Wednesday, June 30, 2010

VFC's Stock House Back Soon

Thanks for all the comments and emails on this site and on Seeking Alpha - I'll be back to posting soon. Appreciate the interest, and thanks to the "VFC's Stock House" 'Get Bash Crew' for keeping my name alive on the message boards.

On a side note to stock trading, how about those 'Silly Bands' that all the kids are buying? Here's VFC's theory on silly bands...

...The bad economy has hurt the implant market enough to where the excess silicone, and silicone that needed to be replaced, had to be put to good use...and so the new kid brand of 'Silly Band' was born.

Nice to know that Pamela Anderson's trash is now every kid's joy.

Only in America.

Be back soon.

Saturday, June 26, 2010

CELH: The Celsius Dip

Shares of Celsius Holdings dipped as low as below $1.50 during this past trading week, before rebounding slightly on Friday to close at $1.83.

No news and average volume (at best) accompanied the drop, although the company did announce that Coast Brands LLC has agreed to manage west coast distribution. Coast brands has the reach to help place the product in a variety of locations, including grocery chains, drug stores and gas, convenience and club locations, according to a PR released last week.

New distribution is great, but it's still yet to be seen if the current marketing strategies will bring in the sales numbers.

The first quarter numbers were somewhat discouraging, showing an actual decline in total revenue, but the previous quarter had produced sales at a growth rate of 77%, so it's still yet to be seen just how much of an impact that Celsius and its calorie burning beverage can make in the market place.

There's no doubt that the business plan needs to start demonstrating some significant sales growth - and quick - because even the company's revised $18-$22 million sales target has left many investors sceptical, and the riff-raff with nothing but time on their hand will use the least bit of scepticism to create the mood of fear, panic and doubt in order to serve their own financial goals.

Let's be honest here, CELH is one of many stocks that have been attacked by a very aggressive 'Get Bash Crew', and let's look at the forces of common sense and human nature for a minute; there are two reasons why someone would dedicate day after day, night after night and hour after hour on stock message boards under multiple IDs trying to create hysteria by speaking in half truths and immature innuendo.

The first reason is that someone or some group of people have a chip on their shoulder. The other reason is because these guys have a nice-sized financial interest as a motive behind their actions. There's no chance that in the financial world of America that anyone would spend that amount of time on one stock without having one of those motives behind them, so don't be fooled - because there's still a few out there that are new to the game that can't see through the BS just yet.

On that note, it's also somewhat satisfying to see that yours truly has his own 'Get Bash Crew' dedicated to discrediting this guy. It just goes to show you, that in America even the average guy (who's better-than-average-looking I will add) with an opinion and a hobby can become relevant, because if VFC's Stock House was not relevant, then these guys would have no reason to dedicate so much time to little ol' me.

I do, however, appreciate the free advertising, because every time these clowns bring up my name in the realms of cyberspace, it keeps traffic coming to the site even when I'm on the road and not writing every day.

As for the subject at hand, CELH, this is still a growth story with potential - in my opinion - and the $1.50 shares are too appetizing to pass up. I'm not going to complain if they bring it back down to those levels - or lower - because I love the risk/reward and the potential for growth.

The volume stinks, there's a general lack of interest in the stock and there's some big players that can easily control the day to day volatility, but this is a story still developing.

Disclosure: VFC is long CELH.

Thursday, June 17, 2010

TTNP: Titan Receives Probuphine Patent Protection Until 2023

It was announced on Wednesday afternoon that the US Patent and Trademark Office has granted Titan Pharmaceuticals patent protection for Probuphine until 2023, barring any term adjustment.

The news was met with little fanfare in terms of share price reaction, although this news solidifies the future potential of Probuphine and confirms the overall value of Titan as a company to any potential suitors out there.

Probuphine has already proven to be safe and effective in three Phase III trials to date and the National Institutes of Health is partially funding the final, confirmatory trial expected to last until the middle of 2011.

Titan also brings in 8-10% royalties on sales of Fanapt, a schizophrenia drug developed by Vanda Pharmaceuticals and marketed by Novartis.

TTNP is an enticing pick while trading for one dollar, especially when considering that VNDA and TTNP have been hammered partly due to some premature performances by a glorified blogger and a Wall Street analyst that can't seem to make up his mind.

Let the players play, but the Titan story is looking very good right now. I still get the feeling that this company is a buyout candidate, although that's just my own opinion.

Disclosure: Long TTNP.

BIEL: Another Product Update, Catering to the Japanese Market

It's been a busy week for the BioElectronics PR staff.

After issuing a company update on Wednesday outlining the status of the pending FDA applications, the company followed up on Thursday with an update on the push into the Japanese market.

According to Thursday's PR, the Allay menstrual pain therapy and ActiPatch products have undergone minor modifications to satisfy the requests of the Japanese market. Among other slight modifications, the Allay patch will include an on/off switch to extend the life of the product.

BioElectronics also announced that the new back pain belt will be made available in Japan first, once the product is officially launched.

Again, I emphasize that BioElectronics is making bold steps to expand international distribution while the FDA continues to move at a snail's pace in response to the pending applications. The potential international growth alone could be enough to support BioElectronics for the short to mid term while the company waits on the FDA. It's also my opinion that BioElectronics may be able to continue to demonstrate growth even if the FDA denies over-the-counter (OTC) clearance in the United States, but the real-deal news for many investors will be an FDA approval and a classification as a Class II medical device.

I've also heard some whispers that the buying restrictions that have been in place by many of the large brokerages are being lifted, although I cannot confirm nor deny those whispers for all of the major firms; I do know that there were never any restrictions placed on the stock with Zecco.

Things are heating up for BIEL, once again, and it could be an interested run later this year. Over the short term, it's possible we could hear news regarding a move to the OTCBB from the pinks - another step towards credibility if that does occur.

Disclosure: Long BIEL.

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ONTY: Stimuvax Back in Business

Shares of Oncothyreon were back to trading for above four dollars on Thursday after the company announced that the US FDA has partially lifted the clinical hold that was placed on the Stimuvax trials in March after a patient in the multiple myeloma trial contracted encephalitis.

Merck KGaA, Oncothyreon's Stimuvax partner, will resume the START and INSPIRE Phase III trials testing the Stimuvax vaccine in the treatment of non-small cell lung cancer (NSCLC).

The Phase III STRIDE trial for breast cancer remains on hold, although Merck KGaA will continue to work with the FDA to get that trial resumed also, according to Thursday's PR.

The fact that the trials are resuming, partially, is good news for ONTY and shareholders of the company, and I still like this one as a mid to long term DNDN-type accumulation play. Updates from the ongoing Stimuvax trials have been encouraging, the company has a solid partner in Merck KGaA and cancer immunotherapy treatments may have gained some momentum in the mainstream with the recent approval of Provenge.

After seeing the reaction of the DNDN stock upon positive Phase III results and subsequent FDA approval, ONTY - with a market cap of just over one hundred million - could realize some huge gains later on down the road if the current trials turn out positive. Any potential spike may not be as dramatic as the one realized by DNDN, however, because Oncothyreon only stands to rake in royalties on sales in the partnership agreement with Merck KGaA, whereas Dendreon developed Provenge without the help of a partner, plans to market the product themselves (in North America) and does not need to pay out royalties to another entity.

I continue to believe that immunotherapeutic treatments such as Stimuvax and Provenge will be the next big thing in the treatment of cancer, although it's also important to keep in mind that many of these treatments have failed in their development, so there is - of course - inherent risk with an investment in ONTY.

That said, I think that the potential rewards outweigh the risks here, but that's just my opinion. Each investor should do his or her own DD.

With the resumption of the lung cancer trials, I expect that we'll here from the company soon regarding the breast cancer trial that is still on hold.

Disclosure: Long ONTY.

Covestor Investment Management

Wednesday, June 16, 2010

BIEL: BioElectronics Updates FDA Application Status

Shares of BioElectronics began the week on a positive note, and a press release (PR) issued on Wednesday updating the status of the company's FDA applications only added to the upward momentum as the stock traded as high as .027 during intra-day trading.

The basic gist of Wednesday's PR is that BioElectronics has provided the FDA with additional information and data to better support the pending classification applications for ActiPatch and Allay.

Additionally, the company has already filed, or plans to file, additional applications either expanding the use of existing product lines or introducing new items altogether.

Regarding the ActiPatch, BioElectronics has provided the FDA with additional information to better support the existing pre-marketing applications. The company also plans to file another 510k application for the approval of an alternative over-the-counter (OTC) product for the temporary relief of pain associated with sore and aching muscles, according to Wednesday's PR.

BioElectronics also requested to change the 510k review of the Allay menstrual pain patch to a Section 513(f)(2) review, citing supporting data that the technology behind the patch is an effective treatment for dysmenorrhea.

On the RecoveryRX front, the company looks to broaden the scope of existing FDA approvals in order to reach a larger target of Doctors and their patients; the current approvals only cover plastic surgery procedures and the new application will open the market to all medical specialties.

In addition to the already existing product lines, BioElectronics will seek FDA clearance for a newly-developed product that treats chronic pain. This product will be eligible for Medicare and Medicaid reimbursement, in addition to coverage by private insurers.

On the international front, already an area of strength for BioElectronics, the Korean medical authorities have approved the ActiPatch for the treatment of muscle soreness and Canada has issued a license to market the Allay patch as a therapy for menstrual pain.

It's been a rough year-to-date for shareholders of BIEL, but Wednesday's PR provides a glimpse into the potential of the company and its products. News has been very forthcoming about the advancement of the BioElectronics technology on the overseas markets, but it's been a while since the company outlined the status of the current FDA applications, as Wednesday's PR did.

There's still nothing finalized or predictable about how the FDA will decide to rule on these pending applications, but for the first time in a while shareholders can get the feeling that the company has a definitive plan and is moving forward accordingly - that's an encouraging sign, in my opinion, and the current movement in the share price would indicate that others feel the same.

There will most likely be some profit taking if the price continues to hang out at the current trading levels - or goes higher - but the strength of the outlined FDA progress and the growth on the international front could line this company up to enjoy a late-year run, if events at the FDA turn out positive.

However, even if BioElectronics is met with additional FDA delays, the fact that over 200,000 devices have already been sold around the world indicates that the company could do very well just based on international growth alone.

BIEL is still a speculative play, but I maintain my position that the mid to long term risk/reward profile of buying this stock for the current trading levels (give or take a penny and a half) is excellent, in my opinion. My personal 'heavy buy' price is still three cents while my 'load the boat' price is still .025 - and I'm still adding.

Keep in mind, the company is far from in the clear and although Wednesday's PR looks very encouraging, there's no way to tell how the FDA will rule. It's also likely that many investors will not consider the potential international market growth as a factor when conducting DD on this stock. Some do not believe that the product will take off in other markets and some just inherently believe that America is the center of the financial world and that no other market could support a significant growth in sales and/or share price.

It's the same mentality that people use when bashing the World Cup over American sports.

When it's all said and done, however, BioElectronics has products that are safer and possibly more effective than the status quo of Tylenol and Ibuprofen, which come with their respective side effect profiles of liver, kidney and stomach damage.

Monday's action made BIEL a 'Stock to Watch' for the week, and now that we know more of what is developing behind the scenes, there's a chance that things can get exciting once again for shareholders of BIEL, maybe as soon as later this year.

Personally, I'm not ready for the price to rise much more than it already has because I'm still looking to accumulate, but I'm not complaining.

Keep it on the radar.

Disclosure: Long BIEL.

Tuesday, June 15, 2010

Briefs: PPHM, CTSO

PPHM: It's been a while since I've mentioned PPHM, but I thought that the highs of April and May were a better time to sell than accumulate, so I left it alone. The mini-run earlier this year was based on a flurry of PRs outlining encouraging results from the ongoing Phase II trials that were to be presented at ASCO.

Now that the hype has died down a bit and the stock is back to trading for around three dollars, Peregrine Pharmaceuticals may be worth a look as a "Phase II accumulation" pick with eyes towards the conclusion of the ongoing trials and the future potential of both Bavituximab and Cotara.

Bavituximab is an anti-tumor antibody that alerts one's immune system to attack the cancerous cells and is being investigated for effectiveness in multiple Phase II trials, including advanced breast cancer and other solid tumor indications. Peregrine is also testing this product for use in fighting infectious diseases, and Phase I trials for Hepatitis C and HIV are ongoing.

Cotara is classed as Tumor Necrosis Therapy (TNT) and carries anti-cancer agents into the core of the tumor and attacks them from the inside out. A Phase II trial testing this product in brain cancer patients is ongoing.

There's a lot of potential with these products, although it's worth keeping in mind that Phase II is a long way from market so it's worth it to keep a handful of trading shares in store to take advantage of any sudden spikes, like the one we saw during the April/May time frame.

That said, if either or both of these products make it through Phase III trials, then the share price will most likely be trading for much higher prices, so this stock is worth a look as a good mid to long term cancer pick for the current prices, in my opinion.

There's likely to be some additional volatility associated with this one being that significant news could still be months away, but it's likely that the company could offer up trial results late this year.

I like the potential of PPHM.

Disclosure: Long PPHM.

CTSO.ob: Shares of CytoSorbents enjoyed a late day surge on Tuesday and closed more than 25% to the upside on roughly double the average volume.

No news was released to spur the rise in price and volume, but the company was due to present on Tuesday at the BioNJ BioPartnering Conference in Princeton, New Jersey.

As I've mentioned here many times before, CTSO is a nice risk/reward pick that could realize very significant gains if its medical device treating severe sepsis successfully advances past the ongoing European Phase III trial.

Tuesday's late surge could be nothing but mere accumulation, or it could be that the company drew some interest at BioNJ.

Keep an eye on the developments.

Disclosure: Long CTSO.

Monday, June 14, 2010

Briefs: HWEG, GCKO, MCET The orders continue to roll in for Hemiwedge Industries. After recently announcing sales to T. Boone Pickens' Clean Energy company, Hemiwedge followed up with an announcement last week of a $512 thousand order last for the Hemiwedge Cartridge valves. This order originated from an energy services customer headquartered in Houston, Texas, according to the press release.

The deliveries of the product will take place during the remainder of the second quarter and into the third quarter of 2010.

These most recent orders from new customers are a nice indication that the Hemiwedge cartridge valves are gaining traction in the market place.

In addition to news regarding orders, I'm also expecting a move to the OTCBB from the pinks at some point, once the company becomes current in terms of reporting financials.

This is one to watch and possibly accumulate on the dips, in my opinion, because if orders continue to roll in and company moves from the pinks, then it's possible that this relatively light-traded stock could make a larger move to the upside.

Disclosure: Long HWEG. GeckoSystems International Corporation, the producer of the CareBot, a home elderly care robot, has issued a couple of PRs lately offering investors insight into recent company developments including the progression of the elderly care robot trials.

On Monday, GeckoSystems announced that the company has been approached by an Indian robotics company interested in a joint venture/licensing agreement to bring the CareBot and the technology behind it to India.

Company officials estimate that their product(s) could have significant presence in the Asian markets, and an Indian partner would certainly boost the future potential of GeckoSystems, although talks are in the very early stages, if we're to take anything from the PR.

It's my opinion that the news is encouraging, but I like these deals when they are completed, not when they are in the 'idea' phase, although shares traded more than 20% to the upside on the news.

Gecko also announced last week that it has updated the company website using a more user-friendly interface which allows users to browse through the latest insights, updates and progress from the ongoing trials for the home trials. Since this company loves to issue PRs, whether of significant relevance or not, any valid information has been tough to find, but the re-vamping of the website should fix that problem.

GCKO is highly speculative, but I like accumulating this one on the possibility that the CareBot and/or the hardware and software behind it will eventually make it past the testing stage to the manufacturing and sales stages.

A product such as the CareBot could be a bit ahead of its time, especially in the midst of a global economic meltdown, but the risk/reward for the penny prices is worth a bit of 'out on the town' money, in my opinion.

Still keeping an eye on Gecko.

Disclosure: Long GCKO.

MCET.ob: MultiCell Technologies, Inc. issued a PR on Monday announcing the hiring of a clinical research organization to manage an upcoming Phase IIb trial for MCT-125, a treatment of primary multiple sclerosis-related fatigue (PMSF).

MCT-125 is MultiCell's lead drug candidate and the Phase II trial has been long-awaited and heavily anticipated by investors who have loaded up at these low levels.

That said, there is no indication as to when the trial will commence or how the company will pay for it, so the question begs as to whether or not there is additional news pending or something in regards to a partnership that is being worked out behind the scenes that would incline the company to start preparations for the trial.

It's possible that the move is just to keep investors interested, but it's also possible that this news is a precursor for more to come.

MCET enjoyed a recent spike in price after the European patent news was released a couple of months ago, but the swift retracement in price has offered investors who may have sold into the spike a chance to re-load for right around a penny, a nice buy, in my opinion.

Monday's PR could be nothing or it could be the start of some real development by the company. Either way, MCET is one worth watching - and accumulating - for the time being.

All just my opinion, each investor should do his or her own DD and invest accordingly.

Disclosure: Long MCET.

Stock Watch: TTNP

Titan Pharmaceuticals is a company and a 'Stock to Watch' this week after shares closed over ten percent to the upside on Monday, most likely in anticipation of a decision by the United States Patent and Trademark Office that is expected to be rendered on Tuesday, June 15th regarding Titan's Probuphine patent.

Any extended patent life for Probuphine would significantly boost the value and future potential of Titan Pharmaceuticals, a company already reaping the 8-10% royalty rewards from the Fanapt licensing agreement. Titan has also been awarded a grant from the National Institutes of Health to cover up to $8 million of the cost of the Probuphine confirmatory Phase III trial.

The Phase III trial is currently recruiting patients and if all goes as planned, will be completed in July of 2011.

Funny enough, driving down the avenue over the weekend I heard a radio advertisement for the trial, recruiting patients for the New York City portion of the trial - the VA Medical Center, NYU School of Medicine and St. Luke's Roosevelt Hospital Center. I know no one cares what I listen to on the radio, but the ad for the product that I've followed for quite a while caught my ear.

You never expect any office the government to meet a deadline - especially when the deadline is self-imposed, but the possibility of a Probuphine patent decision this week makes TTNP a "Stock to Watch."

Disclosure: Long TTNP.

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Stock Watch: BIEL

Shares of BioElectronics traded significantly higher on Monday, before closing the trading day 16% to the upside on relatively average volume. The sharp move, which saw BIEL jump to as high as .019 from an open of .0152, came with no news being released.

The BIEL stock price has been depressed for some time, as developments with the FDA regarding classification and over-the-counter (OTC) approval of the company's products advanced at a snail's pace, at best. There was also a period in time where many large brokerage firms did not allow the buying of the BIEL stock.

The lack of progress on the FDA front and the questionable activities of those brokerage firms tested the impatience of many investors, but in the meantime the ActiPatch, Allay and RecoveryRX products made great strides on the international front, moving into the Japanese, South American, Russian and Canadian markets.

The big news for BioElectronics, however, and the news that investors are waiting on is confirmation from the FDA that the products will receive Class II medical device status which will authorize the company to offer the products OTC in the US as a safer and possibly more effective alternative to Tylenol and Ibuprofen.

Monday's move is far from an indication that BIEL is out of the water just yet, although some will speculate that news could be on the way; possibly regarding a move from the pink sheets to the OTCBB market, or even news regarding the FDA.

News on either of those fronts - or especially news regarding sales numbers - could finally move the BIEL stock price to the upside, but my personal preference would be to see this thing stick to below two cents for a little while longer because I love adding shares down here. Us small investors can't do it all at once, and I like sticking with slow accumulation.

One day does not constitute a rally, but Monday's action has once again made BIEL a stock to watch.

Disclosure: Long BIEL.

CELH: Celsius Launches "The Ultimate Workout Challenge" While The Mario Lopez Tour Continues in Boston

After joining Mario Lopez for Chicago's Healthy Living Challenge earlier this month, Celsius Holdings continued the publicity tour and was a featured sponsor at this past weekend's Boston Health and Fitness Expo at the Hynes Convention Center.

The Celsius booth sponsored the 'Fitness Age Challenge,' according to a press release issued on Friday, a challenge based on a computerized fitness assessment program that offers consumers the opportunity to asses their 'fitness age.' Mario Lopez was on hand to both spread the word of the Celsius product and to also emphasize the importance of practicing a healthy lifestyle.

Representatives of Celsius and Lopez are also on the campaign trail to promote the recently launched "Ultimate Workout Challenge," a summer-long campaign devised by Celsius Holdings to promote a healthy lifestyle and offer workout tips and/or programs. Consumers are able - and encouraged - to upload their own workout programs to the "Ultimate Workout Challenge" website and prizes will be available for the "Ultimate Workout" throughout the duration of the challenge.

According to a brief search on, the new campaign has not caught onto the mainstream in the United States, but has drawn surprising interest in Canada.

The new marketing campaign, which identifies the calorie-burning Celsius as "Your Ultimate Fitness Partner" is full steam ahead, but the true effect of the campaign cannot be measured until we see how it shapes the current and future sales numbers.

That said, any attempt in this country to get off the couch and get moving should be met with enthusiasm, whether it's product promotion or not. Celsius has proven studies behind its health-improving and weight-loss claims, and containing no sugar or preservatives, the product is seemingly a perfect fit to be highlighted in any ongoing health & fitness campaign.

However, it's yet to be known whether the new awareness will translate into sales. Last quarter's numbers were not in line with the company's or investors' estimates, so a bounce-back quarter may be in store if Celsius is to approach the revised 2010 guidance of $18 - $22 million.

The "Ultimate Workout Challenge" is a great idea, let's see if the plan gets turned into great execution.

Disclosure: Long CELH.

Saturday, June 12, 2010

ACTC: Advanced Cell Technology's Stem Cell Line Eligible for Federal Funding

Advanced Cell Technology announced on Friday that the National Institutes of Health (NIH) unanimously approved the company's MA135 human embryonic stem cell (hESC) line for federal funding. An additional seven stem cell lines remain under review by the NIH, five of which were produced without embryo destruction using the company's proprietary technology, according to the PR.

This news is significant for Advanced Cell Technology because it offers a non-dilutive path to secure funding for the development of the pipeline, which could in turn expedite the start of additional clinical trials.

Shares of ACTC continue to trade for under ten cents, a level where I'll continue to accumulate and hold based on the long term potential development of the company and its stem cell pipeline.

I also like Advanced Cell Tech as a potential partnership play. The company's MyoBlastm RPE and HG programs could attract the interest of larger companies looking to boost their stem cell lines, especially if the NIH approves any additional of ACT's lines for federal funding.

While the news is very significant for this company, I wouldn't be so bold as to assume the end of dilutive financing altogether. The pipeline is still in the earlier stages of development and the potential treatments are far from market, but the approval of federal funding is a milestone step for Advanced Cell Technology and re-affirms my confidence that we could be onto something with the ACTC stock.

I'll continue to be a buyer as long as this one continues to trade for under ten cents.

Disclosure: Long ACTC.

Thursday, June 10, 2010

Readers Respond: CTSO

A comment regarding CytoSorbents Corporation:

Hi Vinny,

I am wondering if for the time being we can still see a pop to the quarter range.... or is the sub 10 cent level will continue until later this year.


VFC's Take: The story hasn't changed much for CytoSorbents, aside from slower than expected enrollment and dilution that may limit the upside potential that many predicted back when it looked like trial results would be out early in 2010. According to the most recently released information, it looks more like we'll actually see the results in early 2011.

The stock (then trading under the symbol MSBT) enjoyed a healthy run to over forty cents last year, shortly after having traded for as low as four cents. That run, in my opinion, was based on the assumption that results would soon be forthcoming, but there was also a lot of hype and stock pumping behind that run.

It's a new year now, and we're closer to trial conclusion than last year, so the potential is there for another move to the upside based on expected results - not to mention the fact that there's still room for another round of hype.

Should the trial prove successful enough to be considered a potential approval by European regulators, CTSO can run significantly, although the recent dilution no longer has me looking at a pre-results run of over $1. I do think that we could see forty cents again, however. Upon commercialization of the product, if it gets that far, then I would expect to see much higher prices. There's a general lack of effective treatment for sepsis out there, and CytoSorb could prove to be a blockbuster treatment, if approved.

Keep in mind, this is all just my opinion, each investor should do his or her own DD and invest accordingly.

It's hard to predict exactly when stocks will move and by how much - especially in this highly volatile and uncertain market - but when the speculative stocks move, they usually move quickly before the shorts take it back down. Keeping that in mind, I like to be in before a run materializes, even if it means waiting - and accumulating - for some time.

Right now I like the price of CTSO as a speculative accumulation stock. The risk/reward is still fantastic, in my opinion, although it's important to keep in mind that there's nothing in the immediate pipeline to support a drop in price is CytoSorb fails - the company is putting all resources towards the advancement of this product for the time being. Consider it a 'one trick pony' for now.

The time is ticking, we've just got to be patient and wait it out.

Disclosure: Long CTSO.

Readers Respond: BDSI, KERX, SPPI

A follow-up from Spry regarding BioDelivery Sciences:

There was no fearmongering intended by my comments. I'm just bringing up some points, and I'm glad you responded. I'll be happy to tell you and others about better plays with more diverse pipelines; SPPI and KERX just to name a couple. I believe there are good things about BDSI, but I am also concerned of further short-term dilution if a partnership isn't announced. Also, why didn't Mike Havrilla buy BDSI back after the price fell? He stated he owned BDSI through the approval last July. And yet, in his latest article, he states he has not position. Isn't that a bit odd? Remember, just because someone questions a stock like BDSI doesn't automatically make him or her a basher with an agenda. Thanks.


VFC's Take: Thanks for clarifying your previous statements regarding the BDSI stock. If your intent is to truly share ideas and opinions, then we all appreciate it. The first comment you left was laced with ambiguous generalizations (why buy BDSI when there are better options out there?) with no suggestion and sarcasm (Whatever happened to $7-8+ sustained upon Onsolis approval?). We all know the prices didn't hold. Keep in mind, it's not the fact that you raised questions about BDSI that maybe labeled you a "basher," people do that here all the time, but sometimes the tone of a comment over-rides the actual words. That's a problem that is slowly discrediting, in my opinion.

Regarding your alternative picks to BDSI, I agree with your assessment that both KERX and SPPI are also decent, speculative mid to long term picks and I've stated as much on this board many times before.

My issue with KERX, however, was the quick rise after the Phase III trials were announced and since the trials are still a long way from being completed, I felt it worthwhile to sell into the spike and wait for the price to come back down to earth, as it has over the past few weeks. Keryx has made for great trades over the past year, with all the spikes and dips, but BDSI's steady drop has made it a better accumulation play, in my opinion. I've liked BDSI for around three dollars as a better speculative play than KERX while it was hovering around six dollars.

When comparing KERX for five or six (where the stock had been trading until very recently) and BDSI for three (with an already approved product and technology on the market), I liked the BDSI buy better at the time.

I look at SPPI the same way as BDSI - a decent mid to long term speculative pick, and again - I've stated as much fairly recently.

Which one is the best pick for the current prices? That's up to each investor to decide for his or herself based on DD.

As for Mike Havrilla, you'll have to ask that guy those questions. This is VFC's Stock House, not Mike Havrilla's Home, and I don't know the guy. That's like asking me why Jimmy "Three Shoes" buys and sells stocks. I don't know Jimmy "Three Shoes."

I would assume, however, that many investors probably started unloading at much higher prices around approval time - I did so myself, but as to Mike buying and selling? I don't buy and sell based on what anyone else does. I trade based on my own investing styles and my own DD.

Thanks for the comments, I appreciate the input.

Disclosure: Long BDSI, no position KERX, SPPI.

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Wednesday, June 9, 2010

Readers Respond: MCLN, SSWC, BIEL

MCLN held yesterdays gain on good news to close even today. Very good IMO. This is not a pump & dump scheme to achieve wild yet short lived highs. Volume was fair but modest today which means a whole lot of longs are holding out for better days. The kindling has caught fire here. Now we just need a little oxygen to set it ablaze. The rest of this year should be very interesting.

Yesterday I mentioned SSWC. It reached 35 approx. % more gains today and then retraced a bit to close up one tick. I see a lot of new faces onboard hyping up a storm with this one. It's possible they have showed up to entice a bunch of bagholders in. However if you've got the stomach for it, I'd say there may be at least another double here if not more. High risk, high reward.

BIEL is frustrating the heck out of me, and I haven't been buying anymore. However they claim to be expanding distribution agreements overseas which might just result in some nice sales. That should help regardless of what happens with OTCBB/FDA issues.

These are my thoughts for the day.

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VFC's Take: Thanks for the thoughts, Shep, alwasy a welcome addition.

Regarding MCLN, I still like this one as a mid to long term accumulation pick and will continue to do so as long as progress continues to be made on the growth front.

A lot of potential here, in my opinion.

Disclosure: Long MCLN.

SSWC: Haven't looked much at this one - SpeechSwitch Inc. - but it has gone on a nice run lately on news that the company has reduced its debt-load and has also announced the expansion of the Kenergy Scientific Group, seemingly the sales brand of SpeechSwitch.

According to a recent release, products will go on sale in July of this year.

SpeechSwitch has moved from being a voice recognition company to one that develops alternative energy products - a typical move for these sub penny stock companies that try and play in whatever fields are popular in the market at a specific time.

That said, the potential of this one to pay off as a trade is definitely there, although I'm always hesitant to chase and I always emphasize using 'night on the town' money when playing with these sub penny picks.

Good luck to all - there's a lot of money to be had in these penny plays, but be careful and don't get greedy! Always take profits!

Disclosure: No position.

BIEL: Regarding your comments on BIEL, I understand completely where you are coming from. I liken this one to TTNP when that stock was at a penny or three, pick up some shares and just throw the stock out of sight and out of mind for a while, unless you're adding to the position.

It's sickening for some to see one of their stocks drop so much over such a short period of time, but it's also important to keep in mind that when stocks like this one run, they run big and they run quick. It's hurt me more in the past to give up on something when the story really hasn't changed only to watch it spike big on good news than it has to hold on for a while and accumulate.

If the BioElectronics story had really changed that much, then I might reconsider, but that's not the case. It's a patience game that has also been marred with alleged price manipulation and some shady practices by big brokerage firms.

Is BIEL a sure thing? Nope, nothing is.

Is there a chance the investment will become zero? Yup, always.

Is the risk reward good? I love it, especially at these prices - and I'm not going to complain about the prices, I'm taking advantage of them.

I completely understand the other side though, so I encourage all to do their own DD and invest (or sell) accordingly.

I've got the patience to wait this one out.

Thanks again for the comments and the input.

Disclosure: Long BIEL.

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GNBT: Ready to Roll?

The slide continues for the Generex share price, as the stock now trades for under forty cents, but the question remains as to whether or not GNBT is still worthy of an investment as a good, mid to long term speculative stock pick. In the past I've supported this stock as such and I continue to do so and I especially like adding shares for the current, deflated prices - although with the current downturn in the general market, there's a chance that investors will be able to add shares at even lower prices.

Those taking a chance on the potential of Oral-lyn shouldn't complain about these low prices, rather they should take advantage of the opportunity - in my opinion.

Let's clarify one thing from the start by saying that there are no sure things in the stock market, especially in the world of speculative biotech investing; it's a risk/reward game. If you're DD tells you that the possible rewards of an investment are worth the risk of putting up some money, then jump in a little bit, I say, but not all at once. When opening a position I like to put in a fraction of the total amount that I would like to put in a certain stock - this way I'm in if a run materializes, but still have money on the sidelines with which to average down.

I'm also a fan of having a 'core position' of shares that stick around for the long term while using some trading shares to jump in and out if the opportunity arises in order to end up on house money as quickly as possible.

With all of that being said, it's important not to assume that Oral-lyn is a sure thing, because it's not - especially when dealing with finicky, government regulators who are susceptible to influence (political or financial), personal judgements and biases. The product may not even make it out of Phase III.

However, the risk/reward looks pretty appetizing because if Oral-lyn comes out of Phase III looking like the FDA would sign off on an approval, and if the product makes it to market, then there will be some very significant price increases in store for this stock - and even more importantly, the lives of Type I and II diabetics would become a whole lot easier.

The company recently issued an update on the global Phase III Oral-lyn trial and highlighted several favorable comparisons of Oral-lyn when compared to injectable insulin. In these comparisons, it was stated that patients receiving Oral-lyn treatment had better weight gain and BMI profiles than those who were injecting their insulin for treatment, meaning that the Oral-lyn arm did not gain weight or body mass while those on the injectable variant did. Additionally, there were fewer hypoglycemic events for those taking Oral-lyn, according to a PR issued by the company on Monday.

The demonstrated safety of the product is an encouraging sign, although the real meat and potatoes of the trial is whether or not Oral-lyn works at delivering insulin into the bloodstream of the diabetic patient. That's what we need to know, so while this most release of information looks good, let's not get overly excited just yet. Phase III is still a ways away from being being deemed a success.

However, with over 400 patients now enrolled in the trial, according to a report issued in early April, the time for a full analysis of the trial is getting closer and an interim look is expected at some point in July. If at that point it looks like enough information has been collected, it's possible that further enrollment could be terminated and the company could compile data from those treated and move forward with the FDA NDA submission. As always, we can't assume that will be the case, but it's a possibility.

Currently, Oral-lyn is available through the FDA's IND expanded-access program.

Generex also recently announced that two additional patents have been issued for the company's buccal drug delivery platform, one in Japan and the other in the Ukraine. That puts the total patents for the technology at 160, with 103 still pending.

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On another note, a lot has been made of late about the fact that sales of Oral-lyn's equivalent product (Oral Recosulin) in India have been suspended without any real release from the company regarding that fact.

While it does look a bit shady that the company did not issue an official press release to inform investors of this development, and the issue may be worth some consideration, but I don't think anyone sitting around here investing in Generex based on the potential of sales growth in India. Nothing in any previously released financial statements indicated that India was a jackpot - it's US approval & sales that ultimately matter for the short term.

It's also important to emphasize the fact that the Indian issue is based on the fact that Oral Recosulin was approved "for sales in India without local human clinical trials, as mandated by The Drug and Cosmetics Act." In VFC language that reads: The country of India received no financial considerations (kickback) for the drug approval, therefore the clinical trials will be conducted. Of course, that's just my own opinion.

I don't buy the "If the company lied about that then what else can they lie about" story because the same people spewing that line either manipulate, lie or mislead you every day. Not to mention the fact that those same people vote for shady politicians every day, and we all know how well our politicians tell us the truth.

So on that line, cry me a river.

I may pay the issue more attention if the chief culprit out there crying wolf had a credible record for telling the truth. This sounds like a case of, "Hello, Pot? Yeah, this is kettle."

There's also the issue of the Generex lawsuit vs I know there are many out there who suspect that Generex will receive a settlement of this case, but I don't see that happening. At the end of the day, the statements in question were written in an amateurish biotech opinion blog. While there are many at that like to dress up in Batman & Robin underoos and play investigative reporter from time to time, the fact is that TheStreet is just a glorified blog and I can't believe that any good defense lawyer would have them pay a dime.

But I'm just a guy with an opinion, anything can happen I guess, but I wouldn't hold my breath on a settlement.

As for the pending delisting - I don't see it happening in this market. I won't rule out a reverse split if good news doesn't materialize over the next few months, but I don't think that the market has rebounded enough for the Nasdaq to boot a stock like GNBT off the board. I see an extension in the works and there's always the chance for a speculative bounce at some point.

Again - just my opinion.

All in all, I think it's worth adding some GNBT shares for the current prices based on the potential of Oral-lyn and the developing pipeline.

Disclosure: Long GNBT.

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MCLN: MedClean Announces a Million Dollar Mutli-Year Contract

MedClean Technologies announced a multi-year agreement with Barnett Medical Services on Tuesday, a deal that will ultimately be worth over one million dollars to the company. As part of the agreement, Barnett will purchase the MedClean 4400 Container/Mobile technology and services and will also establish a central processing facility in Northern California. The contract also calls for the disposal of confidential documents as well as medical waste.

MCLN has had some volatile moves over the past couple of weeks, after the stock had been beaten down pretty bad, and announcements like this one will go a long way to reminding shareholders of the company why an investment for the current trading levels could end up paying off very handsomely down the road.

The Barnett deal is just one contract, but an investment in MedClean is an investment in the potential of the company to continue its growth strategy by signing additional deals like this one with already-established partners and entities.

The technology is there and the medical waste market is growing, therefore I still like MCLN as an accumulation pick while the stock is trading at the current levels.

Disclosure: Long MCLN.

Tuesday, June 8, 2010

CVM: What's Up With Cel Sci?

CVM is a stock that hasn't been mentioned much in a while, so let's take a moment to do a brief overview of Cel Sci.

CVM is a stock that I have long considered to be a nice long term speculative buy & hold based on the potential of the company's immunotherapeutic treatment for head and neck cancer, Multikine. Multikine proved to be safe and effective in Phase II trials and Cel Sci was given the green light to proceed to Phase III trials, although the company at the time had dedicated all resources to building a 'cold fill' manufacturing facility near Baltimore, Maryland. That facility has since been completed and validated and the Phase III Multikine study is due to commence at some point this summer, assuming there are no delays.

The Cels Sci stock price hit some fairly significant lows during the market crash over the past couple of years, but quickly spiked to over two dollars when it became known that the company's LEAPS technology could be used as a possible treatment for the H1N1 virus. In collaboration with Johns Hopkins University in Baltimore, Cel Sci initiated a trial to measure the effectiveness of LEAPS vs H1N1 during the height of the swine flu hysteria, but the threat of a pandemic quickly faded and the company was unable to fill the patient enrollment goals for the study.

The failed enrollment goal combined with an all out attack from the infamous, consummate bashers at - who only show up after a stock enjoys huge gains - contributed to the CVM stock retreating back to previously traded levels.

Additional dilution, the uncertainty of the lawsuit with Iroquois and a general lack of relevant news being released by the company have the stock trading at its current levels of under fifty cents.

It's also worth noting, however, that CVM has once again dropped below the radar (volume has been unimpressive when considering the dollar amounts traded) and the short interest is still growing; both of these factors have also contributed to the recent drop, in my opinion.

The way I see it, an investment in Cel Sci is an investment in Multikine. Any development from the LEAPS platform is icing on the cake, although LEAPS products are in earlier stages of development than Multikine. Barring another H1N1 outbreak this fall that would have the regulators issue 'emergency' approvals again, it's unlikely that we'll see a LEAPS product on the market any time soon. Like I said, consider it icing on the cake.

Multikine, however, is a different story. If this product is successful in Phase III trials, then it's possible that we could have another Dendreon story on our hands. The company's Baltimore-area facility is fully equipped and prepared to produce enough Multikine for the upcoming trial and is also capable of commercial production if the trial were deemed a success and Multikine was ultimately approved by the FDA.

Additionally, the facility houses a state-of-the-art 'cold fill' lab that the company intends to use to bring in contracting money once a sufficient amount of Multikine has been produced.

The last couple of years have proven to be very volatile ones for Cel Sci, but the factors listed in this posting combined with a general downturn in the market have given us a sub-fifty cent stock with some pretty huge long term potential. Of course I'll emphasize that the potential is based mainly on the success of Multikine, and we can never assume success until trial completion - even then the FDA has to issue a decision.

That said, it's all about risk/reward, and I like the risk/reward of Cel Sci, as I always have.

I also emphasize that CVM is no different than all speculative stocks in the sense that I like to have some trading shares on hand (in addition to a 'core position' of shares) in order to take advantage of the spikes and dips in an effort to end up on house money or more as quickly as possible - this way if the investment goes to zip then it wasn't a total wash.

For those with neither the time nor the inclination to try and play the spikes and dips, I'd expect to hold CVM for a couple of years to see how the Multikine story plays out.

Both of these styles of investing paid off for shareholders of Dendreon (DNDN), for example. From 2007 through this year, DNDN offered up many opportunities to trade the stock, but even those that hold from the three dollar level were able to sell for over forty dollars - it just took a few years to see those returns realized.

CVM could very well turn into another DNDN over the long haul, but again - let's assume nothing until the trial gets underway and we start seeing some results.

Still a great long term speculative pick, in my opinion, especially if the company can turn LEAPS into something more than icing on the cake.

All just my opinion, each investor should conduct his or her own DD and invest accordingly.

Disclosure: Long CVM.


AVII: Avi BioPharma Inks Another Government Deal

Avi BioPharma, Inc. is back on the radar of late after releasing some positive news reports. On Monday morning Avi announced that it had landed a government contract worth the U.S. Defense Threat Reduction Agency (DTRA) for the development of AVI-7100 (formerly identified as AVI-7367) as a medical countermeasure to a possible H1N1 virus pandemic outbreak. The contract could be worth up to $18 million. Just two months earlier AVI had announced a similar agreement with the DTRA, with that contract being worth up to $4 million.

Last week Avi also announced the positive results of a Phase 1b-2 clinical study for the company's drug treatment for Duchenne muscular dystrophy (DMD). The study included 28 patients and was well tolerated by all, according to reports issued by the company.

This slew of good news for Avi follows a mid- April shakeup of company management that included the dismissal of then-CEO Leslie Hudson. Changes to the board of directors were also made, all the result of an agreement between the company and a shareholder group.

Earlier stages of the Avi pipeline include treatments for the Marburg and Ebola virus. Early studies of these treatments, tested on primates in collaboration with U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), were encouraging and company is preparing to launch clinical trials on humans.

The recent press exposure and signing of new government contracts by the company would definitely make Avi a tempting long term pick, but I'm still reserving judgement on this one after years of having followed the stock and using it as a trading platform from time to time.

I think that first and foremost Avi is a prime example of how a small company with an 'in' in Washington can survive by hyping the latest viral threat and the lure of attracting government money. I say this because AVII traded for around nine dollars during the Bird Flu hype and the company pulled the same routine again on the Swine Flu hype, only this time prospective shareholders are not as impressed and the stock has failed to climb significantly.

The long term potential is there for AVI, although the pipeline is still in the early stages of development and is years away from market. At some point I believe that Avi will need to land a major partner - one not housed in Washington - in order to boost its credibility and become a real player in the biopharmaceutical market. Until then I would expect sideways trading, with perhaps a speculative spike now and then, and more government money. After all, when Washington decides they have a connection to a contractor, then that contractor can milk taxpayer money for a long, long time.

The news has been decent for Avi BioPharma, but the pipeline is still a ways away from market and the only lifeline has come from Washington.

I'm still not sold on AVII, although I'm watching based on the potential of the company's RNA Therapeutics.

Disclosure: No position.

Monday, June 7, 2010

DNDN: The Dendreon Dip

Shares of Dendreon dropped to under thirty seven dollars on Monday morning, closing the day ten percent to the downside at $36.70. A dip in the DNDN share price had been expected by some during the time between the FDA's announcement of Provenge approval and the commercial launch of the product, but Monday's drop may also have been the result of an 'honest mistake' by CNBC who had reported that the supply of Provenge outweighed the current demand. CNBC corrected their mistake later in the day stating that, in actuality, the demand for Provenge outweighed the supply. By then, however, the damage had been done and the DNDN stock embarked on a 10% downward spiral for the day.

Speculation was rampant around the Internet and in the blog-o-sphere that CNBC's 'mistake' was not quite an honest one, but one intended to help out some Wall Street buddies looking to build on their positions for lower prices. CNBC's already suspect track record of honest reporting - including Jim Cramer's questionable tactics - only add fuel to the fire.

That said, whether intentional or not, the damage is done and both existing and prospective longs of the stock should look beyond the alleged manipulation and take advantage of DNDN's dip in price - at these levels and especially if it drops lower.

For all of the controversial history behind Provenge's path to FDA approval, the product is real and the demand is there - as indicated in black and white in CNBC's later article. To be fair to CNBC, the context of the original article did indicate that the original supply vs. demand comment was a misprint. Dendreon is no longer a speculative company or stock - the company has an approved, groundbreaking product nearly ready for commercial launch that could pull in as much as $120 million during the second half of 2010 alone, according to previous company estimates. By 2011, Provenge could be a billion dollar a year product, and that number will - most likely - only grow as production ramps up in Dendreon's production plant in Georgia.

The future is promising for this company, and over the mid to long term, DNDN could very likely become a pure powerhouse in the market - although those that stuck with the company and rode the wave from three bucks already consider the stock a powerhouse winner. However, the short term could be tricky and it wouldn't surprise me to see the stock drop a little further, unwarranted or not.

The sales revenue from Provenge is not yet rolling in and that gives the big players a little bit more time to load up on their positions, which could mean that the big boys are going to keep this one in their buy zone for a while longer. If that turns out to be the case, then this will be a great opportunity for everyone with a mid to long term outlook to load up, in my opinion.

As always, I say buy a little at a time - this way you're in if a run materializes, but there's still money on the sideline to average down if the stock slides any more.

Monday's move undoubtedly created fear and panic for many investors, but look beyond the emotion and concentrate on DD - are the chances good that Provenge will become a bigger winner in the market? VFC says, you bet.

If for some reason this stock drops to below thirty bucks again, I love it. Either way, I think we'll be looking at significantly higher prices in a couple of years from now.

All just my opinion.

Disclosure: No position.

Friday, June 4, 2010

Readers Respond: BDSI

From Spry regarding BioDelivery Sciences:

Management is not supporting the shareholders. I wrote investor relations several times to voice my concerns about the short manipulation occurring and never received a response. Be very careful here.

VFC's Take: Spry has commented here about BDSI before.

Concerns about short manipulation are understandable, as are concerns about the company's lack of effort or ability to do anything about it, but this should be used as a time of opportunity, in my opinion.

BDSI is a mid to long term keeper - I've stated before that I've got this one in my IRA - and any short term manipulation to the down side makes the current prices attractive for those with longer term mindsets.

Onsolis has barely been on the market for very long, is partnered with a well-standing pharmaceutical company in Meda and the product's presence on the international market is growing. Additional products utilizing the BEMA drug delivery technology are in the pipeline.

With the potential of future sales revenues, royalties and milestone payments - BioDelivery stands as a nice long term pick, in my opinion, and any immediate manipulation to the downside is great picking grounds for undervalued shares, when considering the long term potential.

The broad market reached very significant lows in March of 2009 - and I would presume that there was some manipulation by the shorts involved with that one - and I stated then that it was a time to buy, not to sell. I think BDSI and quite a few other stocks are in that same position right now; getting driven down, but I don't believe that they'll stay there.

Disclosure: Long BDSI.

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TTNP: Dr. Rubin of Titan Lands a Position at Curis, Inc.

It was announced on Friday that Dr. Marc Rubin, the executive chairman of Titan Pharmaceuticals, has been named to the board of directors for Curis, Inc. Curis, Inc. is a developmental stage drug company that is developing small molecule cancer drugs to treat currently unmet needs. Curis' three Phase II products are partnered with Genentech and there are two Phase I drugs also in the company's pipeline.

It's possible that Dr. Rubin's new position with Curis is nothing more than him taking on another job in addition to his responsibilities to with Titan, but because of where Titan stands as a possible takeover candidate, the move will certainly lead to some speculation that there is more to the story than him just moonlighting on a second job.

I've long suspected that Titan was a prime candidate for a buyout, I've stated as much many times before in this forum, and it's possible that this move by Rubin is a precursor to additional news that Titan may already be - or is going to be - purchased by a larger pharmaceutical company.

Titan has the 8-10% Fanapt royalty revenue coming in and the potential of Probuphine and the ProNeura drug delivery technology in its back pocket - both could be very attractive assets to a prospective buyer.

Additionally, the company has just recently moved to the OTCBB, adding another level of legitimacy to Titan and its stock. That move off of the pink sheets could have been a precursor to completing a pending acquisition.

It could very well be that Dr. Rubin just decided to take on another position and his decision to do so is completely unrelated to Titan Pharmaceuticals - he also serves on the board of Medarex, Inc - but combine this move with recent speculation that Titan is a buyout candidate and you get some good fodder for speculation.

Regardless of the outcome, TTNP is still a great buy for a dollar, in my opinion, and an even better one if the market were to take it even lower.

Disclosure: Long TTNP.

CELH: Celsius to be a Featured Sponsor at Chicago's 5th Annual Healthy Living Challenge

Celsius Holdings issued a press release on Friday afternoon announcing that the company and its celebrity spokesman, Mario Lopez, will be featured at the fifth annual Chicago Healthy Living Challenge on the fifth and sixth of June at Chicago's Navy Pier.

According to the PR, Lopez will take part in a workout on the Celsius-sponsored main stage and will promote the company's 'Ultimate Workout Challenge' that we've heard so much about up to this point. Little of the talk regarding the challenge has turned to action, and you almost have to wonder if the delay in kicking off the challenge (it was originally supposed to start in May) has to do with a general lack of interest from the public.

Lopez, as the "national spokesman", has done little in terms of active promotion for Celsius thus far, but maybe this kick-off event in Chicago is the beginning of the next phase of promotion for the calorie burning beverage and its celebrity sidekick.

The former 'Dancing With the Stars' contestant and host of the celbrity gossip show 'Extra' has tweeted about the product a few times, but his tweets are an obvious sales pitch that even have his followers asking "How much did you get paid to say that?" If that's the best that Mario has to offer, then it may be best to pull the plug on this guy and move on - kind of like the Mets need to do with Ollie Perez.

It's crunch time for Celsius Holdings, especially after last quarter's decline in sales. With company estimates in the range of $20 million for 2010, the strategy of building loyalty by giving away freebies of the product is being well tested right now, and this event in Chicago needs to indicate the start of some real promotion from Lopez; it's a step in the right direction, at least.

However, a press release issued on Friday afternoon the day before the event starts does not indicate to shareholders that the company is serious about hyping the event.
That's what the politicians do when they don't want to hype the fact that they just raised your taxes - they announce the news on Friday afternoon.

That said, let's see what Mario can do now that he's actively promoting the prodcut and not just himself - well, that's yet to be seen, because we know that guy doesn't like to share spotlight with anyone or anything.

The downturn has stalled in the $2.30 range, but any more stalling or missed numbers from the company in this market could send the stock even lower. I'm expecting the sales numbers to bounce back a bit in the next report, although I'm not expected blow-away numbers and I'm reserving judgement on the company's projections for 2010 until further notice.

I think that we'll see another run in the share price at some point because sooner or later the hedge fund will want to do something with their investment - they're either waiting for a buyout or waiting for the right time to run it, in my opinion, but I don't think that these guys bought in just to watch it drop. There's more money to be made to the upside than the downside - especially when the stock is trading at these levels.

The potential for Celsius the calorie burning product is still huge in the beverage market, in my opinion, and I'll pick up a few more shares before the next report - unless it looks like the promotional campaign is stalling in its tracks. Sales do need to pick up quick, however, because another major financing event would test the patience of many investors because it would be an indication that the product is not selling according to the estimates of the company. In my opinion.

Let's keep it real - I'm a fan of Celsius, but I'm not caught up in Mario Lopez - he gets caught up in himself enough for all of us. Call me if Oprah shows up at this event, espcially if she picks up a can of Celsius. Then we'll be talking.

Disclosure: Long CELH.

Thursday, June 3, 2010

ONTY: Buying Back In

In March I announced that I had sold all of my position in Oncothyreon after information became public that Merck KGaA, ONTY's partner for the clinical development of Stimuvax, had halted all trials of the product after a patient had contracted encephalitis in one of the trials.

Stimuvax is one of the new breed of cancer 'vaccines' being tested in multiple common forms of cancer, including breast and lung cancer.

The share price of ONTY has remained relatively stable since the news, and although I don't fully believe that the stock is out of the clear just yet, I thought it was worth starting a new position based on the future potential of Stimuvax and the possibilities that the trials could resume at some point in the short to mid term future. The company has indicated that the case of encephalitis is not related to Stimuvax treatment, but the medical regulatory agencies will still need to sign off on that theory before the trials could resume.

Additionally, it's still too early to tell whether the lapse in the trials could negate any data that were already gathered. I would have to presume, however - and this is just my own speculation - that there would have been enough data collected over time to get an idea of just how well Stimuvax was performing; maybe not enough to bring before the FDA for approval, but enough to give Merch KGaA and Oncothyreon the confidence to move forward with the advancement of the product.

There's still quite a bit up in the air regarding the resumption of the trials, but the potential of Stimuvax still holds true and the company is not in immediate need of a cash-raising event, so I'm liking this one again as a mid to long term accumulation pick.

There will be another Provenge out there sooner or later, and there's no reason to believe that Stimuvax couldn't make ONTY another DNDN in due time. I'm no Doctor, but I'm speculating that the one case of encephalitis in a patient that received more doses of cyclophosphamide than other patients will not stop Stimuvax in its tracks.

Aside from Stimuvax, Oncothyreon also has two products in Phase I at the current time.

Disclosure: Long ONTY.

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CBAI: Still Highly Speculative, but Still Worth a 'Night On The Town' Risk?

Since announcing the opening of the company's Las Vegas facility in January, shares of Cord Blood America have since traded down to below a penny after reaching a high of nearly two cents in early January.

This speculative penny play has been a goldmine for traders over the course of the last eight months or so, but the question still remains as to whether Cord Blood - with a business plan that relies on being 'stem cell storage bank' can make it as a viable company moving forward.

I never was completely sold on the idea that it could, which is why I've used half of my CBAI shares as trading shares and held on to the remainder for the long term, safely tucked away in the back corner of my portfolio.

I can definitely see the argument that Cord Blood and related companies are 'ahead of the times' by offering stem cell storage services, but I'm still sceptical as to whether the company is too far ahead of the times, especially when the global economy is still on the brink. Stem cell storage could be viewed as just an unimaginable luxury and expense to most.

To address that issue, Cord Blood recently announced the "Afford-a-Cord" payment option that reduces the upfront cost of the service to $495, down from $2075. From there, the monthly payment of storage would be $29 a month for 18 years of storage, according to a recent press release.

The company claims that the change in payment options is a result of years of feedback that identified the upfront costs as a major barrier to attracting new customers. It's my opinion, however, that the growth just isn't there yet, and the company is forced to take steps such as this one just to get customers to sign on the dotted line.

After all, even Cord Blood's most recent quarterly report indicated "minimal" growth over the same quarter from the previous year.

When it's all said and done, I still think that CBAI is worth some speculative 'night on the town' money. The service is one that could catch on - especially with the rich, as they can afford it; no doubt Paris Hilton would do it to preserve her future offspring.

Cord Blood is also looking to take a foothold in the world stem cell storage market with recent mergers and acquisitions in Europe and South America.

I'm still accumulating a long term base of shares, but there's no doubt that I'll have a handful of trading shares on hand until there's any indication that this company can make it over the long haul.

All just my opinion, each investor should do his or her own DD and invest accordingly.

Disclosure: Long CBAI.

MHAN: Still a Speculative Accumulation Pick With Potential

A brief recap of some stocks that may be worth accumulating at their current trading levels:

MHAN.ob: Manhattan Pharmaceuticals, Inc. is still a highly speculative 'night on the town' play that could pay off if the company and its joint venture (JV) partner Nordic can bring Hedrin to market in North America. Hedrin is a pesticide-free treatment for head lice and is already on the market in Europe, although Manhattan has no financial interests tied to the European distribution.

The Hedrin Joint Venture became a little more convoluted recently, as Manhattan described a dispute between the company and Nordic regarding the aggregate number of shares beneficially owned by Nordic. The dispute is significant, in my opinion, as the two numbers are not even close - with Nordic claiming 65.5% of the common shares while Manhattan claims that the number should be closer to 42.9% of the common.

It's unclear how this dispute will affect the progression of Hedrin to market in the US based on what information has been made to shareholders, but you have to wonder if internal rumblings about this dispute had anything to do with the drastic decline in price and then recovery of the share price on a day in early March.

There's been a relative silence from Manhattan over the course of the last few months, aside from a recent private placement that netted the company $3 million last month, but past reports have states that a North American Hedrin trial would be conducted in early 2010 - and so far there has been no indication that the trial is taking place, and we're in mid-2010 now.

I wouldn't expect the trial to take very long, and if completed at some point in 2010, the company's estimate of possibly receiving revenue from sales of the product in the second half of 2011 could still be on track. Once the trial is successfully completed, Manhattan will look to the FDA for Hedrin approval as a Class III medical device.

MHAN is trading very much under-the-radar right now - in my opinion - and any positive developments could lead to quick run in the share price, although I'd temper expectations for the short term and take a 'wait and see' approach regarding Hedrin.

I do like the risk/reward with this one, especially if we see another dip.

Disclosure: Long MHAN.


Wednesday, June 2, 2010

Readers Respond: BDSI

A comment regarding BioDelivery Sciences:

Had Onsolis launched into a different regulatory environment BDSI would be trading above $7 dollars. Sadly, the FDA will continue to allow the REMS disparity to continue for the time being... allowing me to load up on cheap shares.

Onsolis is a "best of class" drug and will eventually produce very strong sales around the U.S., EU, and Canada. It's just a very slow ramp-up in the US considering the REMS and unfair playing field.

I think the expectation was for Onsolis to support BDSI operations in 2010, and while this will not be the case, the peak sales forecasts have unchanged. A good REMS will also allow BDSI to expand to "Non-cancer" indications for BTP... another big market.

Patience might be growing thin and I can understand that. It's up to the individual investor to either sell or accumulate or hold. My guess is that in 2 years we'll be wishing we had accumulated more at these levels.

Appreciate your input, VFC. BDSI will likely go lower from here until a major partnership for BEMA-Buprenorphine is announced... but by then, the cheap shares will be gone.

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VFC's Take: Concur with all. Even while the BDSI stock price dips below three dollars, the international story for Onsolis continues to grow with moves into the Korean and Canadian markets announced recently. It is also expected that Onsolis will receive approval in the European Union as well, but that's not a done deal until it's a done deal.

The real value of this company lies in its future, in my opionion, chiefly with the BEMA drug delivery technology that uses the inner lining of the cheek to deliver drugs into the system.

These sub-three dollars shares offer up a great buying opportunity, in my opinion, when looking at the risk/reward profile - whether it's an average-down play or one of pure accumulation.

Disclosure: Long BDSI.

CELH: Celsius Presenting at the Noble Financial Sixth Annual Equity Conference

Celsius Holdings issued a press release on Tuesday announcing that the company's CEO Steve Haley and CFO Geary Cotton will be presenting at the Noble Financial Sixth Annual Equity Conference at the Hard Rock Hotel in Hollywood, Florida on June 8th.
The presentation will include, according to the PR, the current business strategy and future financial outlook.

With the Celsius dog and pony show on the move to the investment banking get-together in Hollywood, Florida, information regarding the long-discussed 'Ultimate Workout Challenge' should be forthcoming pretty soon, too, as it was mentioned in May that the challenge would be pushed to June - just in time for summer.

One would have to assume - although I'm not a fan of making assumptions - that new marketing campaign announced last month by Celsius would play right into the challenge, and we might even see the company's celebrity spokesman making some rounds with the product, as previously indicated.

The 2010 first quarter numbers were a disappointment for many and did little to keep the CELH share price from sliding below the three dollar level, but it's still a bit early, in my opinion, to predict gloom and doom for this company - as the ever-robust Celsius 'get bash crew' loves to do - while it is in the midst of continued distribution and awareness growth.

That said, it didn't look too professional that the company had to significantly reduce sales guidance for 2010 just months after issuing a bold prediction, so it'll take a very solid quarter of growth in Q2 to 'change those frowns upside down,' as they say, and keep potential investors interested.

The trading volume of CELH has trickled to a near standstill, for the most part, but we still know that Pentwater is holding a very significant amount of shares and those guys will be able to play the stock any which way they want right now - especially with the volume so low.

It's my opinion, that the risk/reward for CELH is very attractive right now, because a bounce back quarter could reverse the current down trend - especially if it looks like there's even an outside chance that sales will reach the company's revised sales guidance of $18-$22 million for 2010.

It would be nice if a celebrity other than Lopez and Snooki (is she a celebrity?) would jump on board, however, but the most important thing that the company could do - in my opinion - is get the word out that Celsius is a unique product on the market and not just another energy drink.

It looks like the new marketing campaign is trying to do just that and Mr. Haley should probably pitch that angle at the upcoming investment banker conference in Hollywood, Florida.

Disclosure: Long CELH.

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