Tuesday, September 30, 2008

Epicept (EPCT), Nice Price Action as we Await Ceplene Approval

With market bouncing all over the place over the past few days, weeks and months, EPCT is one stock that has had a pretty good run.

EPCT traded in the thirty cent range only a few short months ago, followed by a nice jump in stock price and another minor retreat.

The news that has got this stock rising higher on more than the average daily volume is the pending Ceplene news from Europe, where the EMEA is expected to give Epicept the authorization needed to market Ceplene to the member countries of the European Union.

Ceplene is Epicept's lead Oncology compound that is used for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML).

Ceplene's story is one of peaks and valleys, with the peaks hitting the mid-four dollar mark and the valleys bottoming out in the twenty cent range. VFC was buying all the way down into the twenty cent range because Epicept was not, and still is not, a one-trick pony. One trick pony biotech stocks disappear when their one drug candidate fails (SEE Genitope, GTOP.PK). All biotech stocks are risky (and rewardy), but Epicept has five other drug candidates in the pipeline even if Ceplene fails, as it looked like it might after the original negative trend vote issued by European CHMP which sent the stock spiraling downward in the first place.

The smart ones took advantage of the drop and were rewarded when the CHMP reversed course and changed the negative vote to a positive one and the stock jumped into the eighty cent range. After some profit taking, the stock closed today at 91 cents, a nice triple from where EPCT traded just months ago. Nothing wrong with a triple.
Now the change of vote in the Ceplene decision was not entirely predictable, but the negative vote was close enough (one vote, I believe) and reports by Epicept stated that they would appeal this decision. Indications were that one negative vote may be influenced to the positive side due to Ceplene's safe record and the fact that there is no other treatment out there for first remission AML patients. So, in addition to the five other drugs in the pipeline to fall back on if Ceplene failed, the possible change of course made EPCT a good bet at the time. That's why it's important to do adequate DD when getting involved in risky (and rewardy) stocks.

As for the current pending news, the fact that Ceplene received the positive trend vote indicates that the EMEA will follow that recommendation and issue a market authorization for Ceplene in Europe. There's no sure things in life, especially in the stock market, but the chances are pretty good that Epicept gets their marketing approval and the stock price responds positively.

If you're not convinced, it won't be too late. Ceplene is still a while away from making money, so even if the pending news is good, there'll be some profit taking by the gang that 'Buy on rumor and sell on news'. That gang will give us the chance to buy in on dips (not this low, most likely) and accumulate for a while as we get updates on Ceplene's progress as well as updates on the other drugs in the pipeline.

EPCT has been a bright spot in this crazy market, and there's a lot to offer with six drugs in the pipeline. Even after the recent run, I still think EPCT is running below the radar.

The big one with EPCT, in VFC's opinion, is Azixa to treat Metastatic brain cancer. Epicept has partnered with Myriad on this one, and a past update on the Azixa trial sent the price of EPCT into the four dollar range. We're due an update on Azixa at any time.

I'm sold out of my trading shares of EPCT, couldn't help selling after the recent triple in price, but I'm still loaded up with the long shares I've accumulated, and I'll add more on any dips.

One thing I do like to add, is it was the stock market that attracted me to these new cancer treatments in development, especially the immunotherapies, but first consideration goes to the ones out there that are in desparate need of these new treatments. It takes investors to fund the trials that get these treatments in front of the FDA, but it's life and death for the patients. Too many people that play the markets forget this fact.

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Monday, September 29, 2008

Antigenics, AGEN: A Little Bit of Life When the Market is Down Huge

With Congress battling out the details of the Bail Out Bill, and then not passing it, the Market has responded with a 700 point crash today.

First things first, VFC loves down markets because we can get in on a whole lot of discounted stocks and ETFs that will pay us back when the market picks up again, so try not to get scared. Everyone should pay their bills first, but take any extra money and stuff it in the market right now, because it won't be down forever.

On another note, we spend a lot of time following the progress of cancer immunotherapy treatments and their respective stocks over here at VFC's Stock House, and today Antigenics (AGEN), the maker of the world's first approved cancer immunotherapy, received some good news from the FDA regarding it's drug Oncophange.

Back in April, Oncophage was approved for use in Russia to treat Kidney cancer. Although not approved in the USA, the US FDA needed to approve the export of Oncophage to Russia since the drug is produced in Lexington, Massachusetts.

Today, Antigenics received that export approval from the FDA and the stock has reacted with a 12% gain. Although reaching a high of $1.71 today, the stock closed at $1.68.

Regardless of the immediate price action of the stock, the good news is that Antigenics is one step closer to selling the Oncophage treatment on the Russian market. Patients of kidney cancer will receive a possibly revolutionary new treatment and the AGEN stock will respond accordingly when the numbers and results start rolling in.

Antigenics is also planning on submitting a Marketing Authorization Application to the European Medicines Agency (EMEA) by the end of this year, another bit of news that might cause a small bump in stock price.

AGEN has been unpredictable in it's trading, actually trading down since it's approval, but news that Oncophage will now be on it's way to Russia could start an uptrend with this stock.

With the market as volatile as it is right now, expect some profit taking after any bumps in price, but for the little guy, buying on the dips and holding for a while is the way to go.

I've got a few January 2009 call options at strike prices of $2.50 and $5.00. It'd be nice to see those pay off, but who knows with the market like it is.

With AGEN getting this good news, the next big thing in the world of cancer vaccines should be the interim results of the Provenge trials. Due in April, not many analysts predict success for Dendreon's (DNDN) prostate cancer treatment, but a positive indication that Provenge extends life could lead to approval here in the United States. If that happens, expect a huge price increase for the DNDN stock, and huge sigh of relief for prostate cancer patients that have been waiting for Provenge's ultimate approval for too long.

Paradysz Matera

The Shepard Investment Strategist

Saturday, September 27, 2008

Cel-Sci (CVM), Multikine and the Baltimore Facility

Cel-Sci and Multikine
Cel-Sci and Teva

Cel Sci will take control of their new Baltimore facility early in October, bringing the company one step closer to launching their Phase III Multikine trials, in which Multikine will be used to treat cancer of the head and neck.

The Phase III trial follows a successful Phase II trial in which Multikine was proved to be safe, tolerable and improved patients overall survival by an average of 3.5 years, according to released reports.

The production facility in Baltimore will be used to produce Multikine for the 800 patient Phase III trial and for the commercial production of Multikine if the drug is ultimately approved by the FDA.

I've been accumulating CVM over the past year, and at fifty cents, you can be assured that VFC will be accumulating more.

CVM is still a few years away from even beginning to pay off, in my opinion, and we should have plenty of time to accumulate at below a buck before this stock makes any significant move up.

If you follow the links at the top of this entry to my previous posts on CVM, there seems to be a positive outlook for Multikine's effectiveness in treating cancer and it's listed as a future blockbuster in the February 2008 issue of MedAdNews.

CVM is definately a long term pick, and a risky one at that, but one that will pay off huge if Multikine fulfills it's promise and actually does become a blockbuster.
Cancer treatment stocks are always risky and can give you quite the roller coaster ride, but I've got the patience to wait this one out; especially when I can accumulate at these low prices. Buying a stock at fifty cents that has the potential to pay off like this one could would make even Crazy Eddy go insane.
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Cel-Sci, for all intents and purposes, is a one trick pony as of right now. Multikine is the big one for Cel-Sci, although they have pre-clinical drugs in the works, but those are years off. By the time any of them come to fruition, Multikine will already be a success or a failure, so if you decide to buy into this company, Multikine is the reason that you're buying in.

The Current State of Cancer Vaccines

One thing that I like about the Multikine trial is that patients will receive the treatment early before the immune system has a chance to break down. Multikine is one of the new breed of cancer immunotherapy treatments, where the body's own immune system is trained to fight the cancer. Many of the trial designs for these immunotherapies have the drug administered in advanced stages of cancer, so the actual effects of the drug may not be accurate. The immunotherapies need a strong immune system to battle the cancer, but if the immune system is already deteriorated, it may be hard to tell if the drug is actually working or not. VFC is by no means a medical expert, I'm just using common sense here.

Multikine has a better chance of a successful trial, in my opinion, since it will be tested in patients who are not in advanced stages of cancer.

I'll be accumulating CVM for at least another year and then I'll sit back and wait for the Phase III trial results. I'll be sure to follow any new information regarding CVM and post it here, at VFC's Stock House.

We're years away with this one, but patience with CVM could pay off big.

Paradysz Matera

Friday, September 26, 2008

Help Carl Fight Prostate Cancer

I'm a little late posting this, but readers of VFC's House, VFC's News House and VFC's Stock House have followed the Provenge Trials and others like it.

The Current State Of Cancer Vaccines

A friend of mine is competing in Athletes for a Cure tomorrow and is accepting donations towards raising money to fight prostate cancer. If you're looking for a cause to support and have a few bucks to spare, please feel free to support Karl in his fight against prostate cancer.

Carl's personal donation page is here, please give Carl a boost as he supports this just cause in fighting Prostate Cancer:

As many of you may know, a small company named Dendreon (DNDN) has developed a cancer vaccine, Provenge, that treats cancer of the prostate. Provenge received an approvable letter last year from the FDA, but indicated that they may approve Provenge if interim results from the ongoing IMPACT trial provide proof of extending the life of patients. Those interim results are due at any time now.

DNDN Up Big In Down Market

Cell Genesys (CEGE) is another company with a prostate cancer vaccine in trials, GVAX, although they have recently halted their trial due to an increased death rate when GVAX was used in combination with Taxatore.

Cell Genesys Halts VITAL I

CEGE Revisited

For more information about Carl's cause, here is the email I received from my long-time friend:
Dear Vinny,

As you may be aware, I have been diligently training for the CrossFit Fight Gone Bad event on Saturday, September 27. In addition, I am committed to supporting both the Prostate Cancer Foundation and the Wounded Warrior Project.

Prostate cancer is the most common non-skin cancer in America, affecting one in six men. Men are 35% more likely to be diagnosed with prostate cancer than women are to be diagnosed with breast cancer.

Athletes for a Cure, a program of the Prostate Cancer Foundation, is a fundraising and awareness program to assist individual athletes in their quest to raise money for better treatments and a cure for prostate cancer. The Prostate Cancer Foundation is the world’s largest philanthropic source of support for prostate cancer research with a simple, yet urgent goal: to find better treatments and a cure for recurrent prostate cancer.

The mission of the Wounded Warrior Project is to honor and empower wounded warriors.

I am dedicated to this race and hope that you will support me in reaching my fundraising goal.

If for nothing else it would be great to hear from you.

Follow This Link to visit my personal web page and help me in my efforts to support Prostate Cancer Foundation

Thanks for any support to Carl and the cause for which he is fighting.

Saturday, September 20, 2008

Titan Pharmaceuticals (TTP), I'll Buy in For a Quarter

In what was supposed to be the Year of the Titan, Titan Pharmaceuticals has done nothing but disappoint in 2008. Share value was obliterated on a slew of bad news over the past few months, and I sold half of my TTP position at around sixty cents, for a loss of course. The other half I've rode down to the current levels. I've been on the sidelines to see if the stock price would drop any more.

I'm comfortable buying shares of TTP at the current levels. Any tidbit of positive news can bump the stock up for an easy double and investors can recoup some of their losses. Even for those that are averaged in over two dollars, buying shares here at a quarter could go a long way to recouping losses if any good news is released.

At this point, the most imminent news could be an announcement on a partner for Probuphine. Marc Rubin, CEO of Titan, has indicated in recent earnings calls that a partnership deal may be in the works. Finding a partner for Probuphine could push the stock over a buck, which would be a quadruple from here.

Other potential good news would be Vanda's (VNDA) complete response letter to the FDA regarding the non-approvable letter for Iloperidone. I don't logically see why a response would bump up the price of either VNDA or TTP, but investors are fickle, and sometimes silly, people. VNDA rose ten percent the other day on news of the response. Another Phase III trial is likely before the FDA will even consider Iloperidone again, so it could be another year from now before VNDA is even thought about again. From these levels, TTP is the far better bet to make any significant move up.

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The Spheramine news was somewhat shocking. Previous updates from both Bayer and Titan seemed positive regarding the ongoing trial and patients had stated on medical blogs that they had responded positively to the treatment. I'd hope that the company would provide more insight into what happened there. Simply put, the trials failed, but I wonder if Spheramine is dead or if there still may be life to the treatment.

In any case, a quarter per share is low enough for VFC to buy back in and make up for some losses. This doesn't mean I'm buying back in for the long haul, the second we get a double I'll sell those trading shares that I'm buying at this level, but I'll still hold onto the shares that I didn't sell after the tumble in July and August to see what happens with Probuphine.

Another possibility is a buyout. Titan has a fifteen million dollar market cap right now which is absolute chump change for an established Pharma. Probuphine has potential for two indications (opioid addiction and cronic pain) and Titan has some unknowns (DITPA, Galium Maltotate) that may be worth the risk to a big Pharma. A buy-out over a dollar, in my opinion, is always a possibility.

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SIRI, Loaded With Debt, The Shorts Have Unleashed on the Stock

The SIRI stock has taken quite a hit lately, even following the news that the FCC finally bought off on Sirius' merger with XM. A few factors contributed to the sharp decline in share price of the SIRI stock, but the biggest factor is investor jitters about the huge amount of debt that will come due next year for the company.

It's been argued that the DOJ and FCC killed the company by taking 18 months to approve the deal; both companies were left up in the air about how to move forward. For VFC, it was a huge surprise that it took our Government eight months longer than they had planned to make a decision. It's a good thing these guys aren't on the front lines where you make real decisions.

Another major factor contributing to the downward spiral of the stock is the large amount of short selling of SIRI.

Short sellers have been getting a lot of attention from Government regulators and the Fed these days, albeit a bit too late. They're becoming the scape goats for the collapsing financial stocks and much of the blame for the down market should fall on these short sellers. However, the fact that the shorts have been so unregulated by the SEC for the past decade has just as much to do with the collapse of the market as the short sellers themselves. If you keep letting the kid take the cookie from the cookie jar without saying anything, the kid is going to take more and more until you finally put a stop to it; or until the kid collapses from having too much of a good thing. That's what's going on now, the SEC and the Feds are trying to save face because they've turned their back on this for a long time.

Short sellers are investors that bet on a stock price to decline. In short, (no pun intended), they borrow shares and sell them at one price while betting that the stock will decline. Once the stock declines, they buy the shares back at a lower price and pocket the difference before returning the shares. Covering is the term used when the shorts start buying the shares that they 'sold' back so that they can be returned to their rightful owners. When shorts start covering all at once it puts buying pressure on a stock which moves the stock north. Naked shorts, on the other hand, don't even have the shares to account for (naked), but play the same game without ever delivering the shares. The naked shorts are the ones getting pinged on most by the Feds right now.

Most of the attention is being paid to the financials, but it's a good bet short sellers from around the entire market are going to start covering, and many have already begun. That may be why SIRI recovered some of it's value last week. I couldn't see SIRI staying at under a buck for too long anyway, but a mass short covering around the market may help the stock recover quicker than we expected. Once the debt issue is settled, or Karmazin outlines his plan, the stock should rebound a bit more.

Slowing subscriber growth is also putting downward pressure on the stock, but little by little the company is signing up quality talent for lower costs than what Stern cost; and commercial free music like the BEAT on Sirius channel 36 make the $12.99 a month more than worth it.

Sirius may reap some benefits from short covering, but probably not to the extent of DNDN.

Personally, I wouldn't mind SIRI sticking below a buck for a while longer for some good, old fashioned VFC accumulation. Accumulated now should pay back a few years down the road.

Zecco Holdings

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Thursday, September 18, 2008

What to do with the Market Dropping? VFC Says BUY!

When the stock market plunged over 400 points yesterday, millions of people pulled the sell trigger and got out of their investments as quick as they could to avoid further losses. Many of those people were sitting on the sidelines while the market rebounded today, rising by over 400 points. But aside from the rebound, even if the market dropped again today, selling is the last thing on VFC's mind, unless I'm trading in and out of a particular stock.

While people are panicking in a down market, I'm loving the buying opportunities that the down market has created for the average investor, as all down markets create great buying opportunities. If there is ever a time where a small investor can count on fairly large percentage gains, it's when the small investor buys in the down market and rides it up when the market rebounds. And the market will rebound. It may take a little while, but the market always rebound. It rebounded after the crash before The Great Depression, it rebounded after the crash in 1987, it rebounded after the tech bubble busted and it rebounded after 9/11. With the market down like it is, VFC is gobbling up the discounts while others are selling into the downturn.
The old investing strategy of 'Buy Low, Sell High' is tough to abide by because you can never predict when the actual low or high is in front of you, so ya gotta use your good judgement and do your DD. Even though the market may not be at a bottom right now, it's low enough for me put money in places that I wouldn't in an up market; in ETFs and the 401k. I don't put as much money into the funds when there is an up market, because they lose too much value when the market goes down. I'd rather buy funds in the down market and get the bigger percentage gains when the market goes up. I like to buy funds low. But that's just me.

An ETF, for those that may not be familiar with them, are Electronically Traded Funds. They are funds that trade as stocks. There are ETFs made to mimic the performance of an index, foreign markets or whatever else. As they've gained popularity, the amount of funds has grown. They're not a favorite of mine, but right now I'm adding to my positions in SPY (follows S&P) among a few others. Now is the time to get into ETFs, in my opinion, while the stock market is down. The percentage increase will be a lot better when the market rebounds. If you bought ETFs last year when the market was soaring, you're down now, which isn't a thing unless you sell, but when the market rebounds, you'll have a lot of ground to make up just to get even before you are even in the green again. You're in the same boat with your mutual funds. There's very few funds out there that beat the market and fewer that make money when the market is down.

If you're a government employee or a military servicemember, now is the time to funnel your funds into the TSP. While everything is getting hammered, get in on the 'cheap' and reap the rewards later. The rewards may not be immediate, or even next month or next year, but they will come. You've just got to have patience.

I only bring this up because I know too many people that have been selling into this down market instead of taking advantage of the huge discounts that are out there. I'm talking about people that are saving for the future who are scared and are selling now at a loss. If you're in for the long haul, then HOLD for the long haul! The market will rebound. The market will rebound and you don't want to be on the sidelines when it does.

An up market tends draw in more new investors than a down market, and that's a shame. Too many uninformed people buy into the up markets based on a positive feeling; everyone else is making money, so I can too. It's human nature to follow the positive feeling, but unfortunately these people will again sell on the negative feeling when the market drops. These people lose their money and will probably never get back into the market. They'll trust their hard earned money with 'money managers' that will invest them into funds and rape their savings with hidden fees.

That's good for some people, you need stomach to invest in stocks, especially during the bad times and if you haven't got the stomach to invest in a down market or deal with volatility, then you shouldn't be in stocks and the money managers are for you. But ANYONE can do ETFs. I personally hate ETFs and mutual funds because of the relatively small returns you get compared to stock gains, and I don't like all the hidden fees, but I am buying ETFs right now and throwing money into TSP, only because the returns will be worth it after buying at this level.

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The point is, instead of selling now, BUY!. This doesn't go for all of your investments. If you've done your homework on a particular stock, and nothing has changed with the reasons why you bought it, chances are it is only down because the market is down. That means you should buy more of that stock at a discount. If it was good enough that you decided to buy it at a higher level, and the only thing keeping it down now is the broad market condition, then it should be an even better buy now.

There's plenty of stocks being sold at a discount right now. The stocks will rebound with the market. I'm not suggesting getting into financials (the ones still standing) right now unless you've got a huge tolerance for risk, but there's plenty of safe areas and stocks to invest in right now that are only beat down by a bad market and they should rebound nicely. I like General Electric (GE) and Nordstrom (JWN) as two of these. Nordstrom is a victim of a retail slowdown and will bounce back when the economy picks up. Nordstrom's customers are generally those that have money when the market is up or down, so I expect a turnaround there. GE has been hit by bad news as much as a bad market, but I feel confident buying at these levels, just over twenty bucks, because GE isn't going anywhere. It'll be a steal in the long run, in my opinion.

There's a lot going on with Dendreon right now (DNDN) and CPST is a steal at these levels, in VFC's opinion, recent stock offering aside.

The point is, don't be one of those that sells out now only to be on the sidelines when the market rebounds. The economy will rebound and the market will rebound. The truth is, regardless of how much the politicians tell us that we are in a horrific state, downturns in the economy and the market are normal. The economy works in a cycle; you have ups and downs. This downturn is more pronounced because of the housing crash, but that is more the result of predatory banking practices and the fact that most of America did not understand basic principles of finance and took on more than they could chew. The American way is to live by credit and that practice kept getting more and more pronounced until things just imploded.

Before anyone goes out and purchases a house they should be well versed on the different types of loans that are out there AND they should be buying a house that fits their budget.

VFC loves the down markets, more than I love the up markets. The volatility is great for trading stocks and it's great for percentage gains down the road.

Don't panic right now, BUY!

Zecco Holdings

The Shepard Investment Strategist

Wednesday, September 17, 2008

Dendreon, DNDN; Market Down Huge, But Dendreon Survives

The big news is coming. Within weeks we should hear interim results for Dendreon's IMPACT trial. The trial will tell us if Provenge, Dendreon's prostate cancer treatment, increases survival rates for patients with advanced prostate cancer. If the news is positive, the FDA has indicated that it will approve Provenge based on these interim results. If the interim results do not show increased survivability, patients and investors will have to wait at least another year for the final results.

Search the pages of VFC's Stock House in the Google bar above or in the blog history on the right to read up on the Provenge saga.

Cancer Vaccines, Where are They Now?

The Provenge news is a few weeks away, but the news today was DNDN rising 10% in one of the worst days in recent Wall Street history. Many took this increase to mean that the interim results were leaked, indicating positive news, but the truth is, if that were the case I would expect a higher increase than the 10% we saw today.

More likely is the fact that the SEC has indicated that it will be clamping down on naked shorts. DNDN is continuously at or near the naked short list, and the fact that the naked shorts will have to cover should lead us to quite a few days like today. Additionally, the fact that the shorts will be covering leading up to the release of the Provenge news sets us up for some volatility. Anyone invested in DNDN for a significant amount of time should be immune to the emotional effects of the volatility in this stock, this hasn't been an investment for those that are weak in the stomach, but the next few weeks will test all our patience and tolerance for risk. If you're new to DNDN, be prepared for the roller coaster ride that's coming up.

- While the shorts are covering, we could get some nice price swings.

- If the IMPACT results are good get ready for a roller coaster ride up, especially if the shorts are covering into the spike. After the rise, I wouldn't be surprised to see the share price get knocked down as new shorts attempt to get some of their losses back after the increase.

- If the results are negative, the stock could get cut in half, or more, and the shorts won't cover until the stock is beaten way down. On negative results I wouldn't be surprised to see the stock at or below a buck for a little while. If that happens, you know VFC will be loading up down there.

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The general consensus on Wall Street, judging by my own research, seems to be that Provenge will not meet the specified interim endpoints.

We can only play the waiting game on this one. The real story is that of the patients waiting for this treatment. Stock gains and losses are always secondary to life. That's something that many on Wall Street and in the financial world seem to forget. And that fact is why the conflict of interest accusations against two doctors who voted on the FDA's advisory committee last year are such a big deal. It's a bad sign when doctors make medical decisions based on their own investments. That's what may have happened last year, and in large part because of those doctors, prostate cancer patients have been forced to wait another year for a treatment that could save or extend their lives, in VFC's opinion.

For now, expect some volatility leading up to the decision as the naked shorts are covered and investors trade in and out of DNDN in anticipation of the big news.

Another prostate cancer treatment, GVAX by Cell Genesys, has recently halted both of it's prostate cancer trials due to an increased amount of deaths in one of the trials.

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Epicept, EPCT, Preparing for Ceplene Launch in Europe

In a recent Press Release, Epicept Corporation (EPCT) just announced that the company has ammended it's December 20, 2006 licensing agreement with DURECT Corporation granting DURECT exclusive, worldwide rights to certain EpiCept intellectual property for a transdermal patch containing bupivacaine for the treatment of back pain.

The terms of the amendment, as outlined in the PR:
Under the terms of the amended agreement, EpiCept has granted DURECT royalty-free, fully paid up, perpetual and irrevocable rights to the intellectual property licensed as part of the original agreement in exchange for a cash payment of USD 2.25million from DURECT.

It looks like Epicept took the cash from this lecensing agreement as an alternative to further dilution of the stock. The stock has been diluted a couple of times since the drop into the thirty cent range. The decision to take the cash from the licensing agreement will carry the company over until the upcoming Ceplene news.
The company anticipates a final marketing authorization from the EMEA for Ceplene sometime in the next several weeks.

Ceplene's path to marketing authorization in Europe has been a roller coaster ride that currently has EPCT trading in the sixty cent range, but earlier this year the stock had been trading in the thirty cent range following a negative trend vote by the EMEA regarding the marketing authorization for Ceplene. Upon review, the EMEA reversed their decision, but the reversal did not instill a whole lot of confidence in investors, as the stock continues to trade under a buck.

EPCT is currently one of my favorites. The risk reward for this stock right now is laughable. If Ceplene receives the marketing authorization in a few weeks, the stock should double almost immediately, to be followed by some profit taking, then an uptrend leading to much higher gains next year. If Ceplene does not receive the marketing approval then the stock will be cut in half, but the company would still have five drugs in the pipeline, including Azixa, that could rebound the stock in a big way down the line.

EPCT is by no means a one trick pony.

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Azixa, the company's drug to combat cancerous metastatic tumours, showed promising results during a Phase I trial tailored to treatbrain cancer. The stock has reached nearly five dollars on updates of this drug alone. Epicept has a licensing agreement with Myriad in which Myriad takes care of most of the legwork regarding Azixa's trials, production and marketing, while Epicept will receive milestone payments and a percentage of sales. Azixa is a promising candidate to look to if Ceplene fails. For now, however, the real news regarding EPCT falls with Ceplene.

The news should come soon, around the time Dendreon releases it's interim Phase III results for Provenge.

Search "EPCT" in VFC's Stock House's Google bar, or scroll through blog history on the right, to find more write-ups on Epicept.

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Monday, September 15, 2008

Interview With the CEO of Celsius Holdings, Steve Haley. Celsius is the First Energy Drink That Burns Calories

The recent Celsius launch of two non-carbonated Green Tea flavors was an exciting development for fans of the Celsius product and for investors who are counting on eventual solid returns for their investment in the company's stock, CSUH.OB, which currently trades for about seven cents.

Celsius, the world's first energy drink that burns calories can be bought on Amazon.com and at many other retailers that are listed on the Celsius website. The biggest national chain that carries Celsius is the Vitamin Shoppe.

I emailed Steve Haley, CEO of Celsius Holdings earlier today with some questions that I had, and some questions that other investors have had. As usual, Steve was very quick in his response and I'm posting my email and his responses below. My questions are in Bold and Mr. Haley's responses are in italics.

Mr. Haley,

I have a few questions that myself and some of the blog readers have come up with and I was hoping you could answer them to the best of your ability, within reason.

1. The Jorge Hane deal was announced months ago. What were the specifics of the deal and how can we expect Jorge Hane to benefit the company, the product, the investor and distribution? (Aside from having his name attached to the website.)
We are working with him for his first distribution deal in S. America. Hopefully it will be quite large and impactful. We are also in the beginning stages of some product additions that his network will be able to exploit. It is still early. We announced earlier than we did the Mid-East relationship because we felt it was material. It took almost a year before the Lebanon order became real. Main hold up is the governmental hurdles for each country. We also hope to utilize him more on the marketing front. I know this is not giving you too much substance to discuss but there is not too much more that I can say right now.

2. A recent article in the South Florida Business Journal stated that Celsius had a national advertising campaign, package redesign and retail roll out ahead. We’ve seen the package redesign, and it looks great. Celsius is a great product and many store managers I have spoke with believe that Celsius would fly off the shelves if people knew about the product.

- What are the plans for the national advertising campaign? Can we expect national Television ads, national Print ads or National Radio ads? Are Satellite radio ads being considered? We are in the process of creating both TV and radio ads built on some neat themes and sounds. Took a little longer than planned to wrap up some of the IP. Radio may start this week. TV will be produced soon but we may not start the media buys until after the elections. We will run in some test areas first to make sure we have it right and then roll out to areas where we have distribution.

- Can we get more specifics on the retail roll out? Are there national retailers in the works?
Many in the works. Tough part is they are planning six to nine months out. For example, we had some great meetings last week that will lead to being in two retailers’ ‘plan or grams’. They won’t take effect however until March in one case and May in the other. As I have said on multiple con calls, the results you see now are from ground work laid many months before. We are doing a lot to have a big push in January. I know investors want much more quickly (as I do) but the larger the retailer it seems the longer the planning cycle.

- Can we expect a wholesaler such as Cost-Co to stock Celsius anytime soon?
Maybe. It is a very tough thing to navigate. Local distributors will just about not take on a new brand if it is being sold in Costco at a price that their accounts (retailers) would be buying it from them. We are working on some but have to time it right and do it in the right geographies before we would do it nationally.

- Has the company approached the military exchanges about stocking the product? (Navy Exchange or Army and Air Force Exchange Service)
Not aggressively enough. I really want us to but there is only so much we can do at once. I may have a broker take it on next quarter.

- Are there deals in the works with national Gyms, such as Gold's Gym or World's Gym?
Working on almost all of them. Tough part here is for most of them, the fruit bar/food part is not associated with the gym side. Also, some of them have national exclusive agreements with Coke. We are working to get around them but in some cases, Coke is putting up a strong line in the sand.

3. I’ve encountered numerous occasions where the Celsius website advertises the product as being sold in a specific location when, in fact, it is not. A Bloom supermarket in Odenton, Maryland was the most recent location that did not stock the product while the website listed it as being sold there. A General Manager for Albertsons in Southern California told me earlier this year that they did not re-stock the product once they sold out. Is the company taking any action to ensure the product is on the shelves before putting a location on the website? When we bring on a large chain and their strategy is to use their own warehousing system (like Bloom does) we depend on what they tell us. We don’t have the manpower to go to every store on their list to verify that Celsius was placed as planned. As we grow and get more resources (employees, ambassadors, local reps, brokers, etc) we are better at it but it is still something that we do not control. Also, there are some stores in some locations that the local management overrides the corporate planogram. We try to find this by analyzing the scanning data but when a chain is new it may take months for us to be alerted to it so we can take that location off the store locator.

- Are reorders from current retailers meeting the company’s expectations?
No but they are increasing. I, of course, want them higher. Some retailers get behind the brand better than others.

4. Earlier this year, you stated that the company would be releasing a new product. The Green Tea brands are amazing, especially the Peach-Mango, and I have confidence that they will catch on. Are these Green Tea brands the new product or is there more in store?
There is more in store but we are still refining it. I had hoped we would be launching this quarter. It has taken longer to perfect and as it got delayed, we did not want to take away some focus from the teas. I actually thought the new product line would be out before the teas. I am not sure if we will be able to do it in Q4. We may hold off for a bigger launch in early 2009. Depends on the progress the next few weeks.

End of questions.

One of the reasons why I am confident in our investment in Celsius is the strength of the management team. Mr. Haley and other members of the staff have always been honest and responsive when I've corresponded with them. They're building a business slowly and efficiently and I think we are on the verge of breaking out; not necessarily in the terms of share price just yet, but in terms of consumer awareness.

A review of the responses.

1. The Jorge Hane deal has long been a concern of mine. We haven't heard anything about that deal since it was announced. Now it looks like progress is being made on that front. Hane's push into South America could rival the Lebanon deal. Mr. Haley's answer quenches my thirst for information regarding the Hane deal, only because we have not had an update of any kind.

2. Sounds good to me. Large chains and big business think quarters down the road, so we, as investors, need to practice patience. I do believe there would be a strong following in the military ranks if they could get the military exchanges deal done. The Gold's Gym I've been to is loaded with Enviga, so I could understand Coke's hesitance to let in competition, especially since Enviga is a far inferior product to Celsius.

3. Good explanation to my concern about some stores not carrying the product while the Celsius website lists them as carrying Celsius.
An honest answer about the reorders. They're not meeting company expectations, but they are increasing. The reorders have been a concern of mine and we'll have to let the numbers in the conference call speak for themselves. Once we see the advertising campaign kick in, the reorder numbers should drastically increase.

4. The teas are NOT the new product. This is intriguing. I think the Teas are going to do very well, maybe even better than the original drinks. The thought of another product on top of that is bonus.

Mr. Haley also made a statement in response to question number two that I liked; investors want results a lot more quickly than they're coming. When I invested in Celsius I had a five year plan, I knew this business was at it's beginning stages and I'll sit it through because I think this stock will be well above where it is now in a few years. Admittedly, I started getting a little worried through these last few months, but if the company acts on all the items Mr. Haley pointed out today, then I'm just as confident as ever that we have a winner. The key is the advertising campaign. The website is up and running and distribution is decent, it's time for people to know the product. Once the product awareness is in place, the product will sell itself. Also, once the product awareness is in place, the stock gains attention as well; many people like to chase fads. The key is to be in before the product and the stock takes hold, and thats where we are today. I truly believe we're in on the bottom floor.

If the company can make it through the next few quarters without major dilution or worse, then we could be in for a pleasant surprise with CSUH.OB.

The CEO sounds committed to excellence and I don't believe Mr. DeSantis, who recently climbed aboard the Celsius express, is one who accepts failure.

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Saturday, September 13, 2008

Cell Genesys (CEGE), VITAL-I is Halted

Shares of Cell Genesys (CEGE) plummeted after the company announced that they had halted their Phase III VITAL-II trial due to a high level of deaths in the control arm of the trial. The VITAL-II trial combined GVAX, a treatment for Prostate cancer, with Taxatore.

On September 11th, the FDA gave the order to halt VITAL-I also; this trial treated patients GVAX only.

Both of these events are huge setbacks for patients and the advancement of immunotherapy treatment to fight cancer.

On the stock front, CEGE dropped into the sixty cent range on their initial bad news before spiking to over a buck the very next day. With both trials halted, the share price could be expected to hover in the fifty to seventy cent range until there is some resolution. It's highly probably that the VITAL-I trial will continue after an inquiry into both trials is concluded. By no means do I have a clue, but it's my inclination to believe that GVAX in combination with Taxatore was too much for these patients with advanced prostate cancer to handle.

We may have seen the end of VITAL-II.

I'll still accumulate in the sixty cent range, but it could be months before we hear some real updates from the company or the FDA.

We should get mid-term results from Dendreon's Provenge trial before we hear from Cell Genesys again.

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Friday, September 12, 2008

PCYC Back Into Buying Territory After a Recent Run-Up

MOVED TO:  http://vfcsstockhouse.com/blog/article/-pcyc-back-into-buying-territory-after-a-recent-run-up

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BDSI, Biodelivery Sciences Giving That Second Chance!

Not too long ago we watched BDSI run higher...and higher...and higher...and VFC hated watching that run from the sidelines; those are the times when teardrops fall in the shape of dollar signs.

The news that launched the run gave us the inclination that we may get a second chance to buy in and hold BDSI in anticipation of the FDA deciding the fate of Biodelivery's leading drug candidate, Onsolis, in early 2009. The company received a positive response letter from the FDA stating that they have not seen any major problems with Onsolis, which treats breakthrough cancer pain, indicating that the FDA may approve next year.

It's never safe to have good faith in the FDA, however, as Dendreon knows very well.

Biodelivery Sciences is not a 'one trick pony', there are two other less-advanced products in the company's pipeline, but all bets are on Onsolis right now.

After missing out on the last run-up I'm ready to now take my chances and buy some shares during the upcoming week. The stock price dropping under three bucks gave me the buy signal I was personally looking for, although the stock may drop even lower. Early next year is still quite a ways off, in the stock-trading world, so I expect some volatility until next year.

Even so, I'm buying the 'hold' shares now, and if the stock drops lower I'll get some trading shares to play with.

Enjoy the second chance with BDSI!

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Capstone Turbine (CPST), a Great Buy at This Price....

Capstone Turbine, CPST, is back to the level where I'm calling it a great buy.

I found CPST about a while back when I was looking for a 'green' addition to my portfolio, and at the time I started buying CPST, the stock price was sitting pretty at right around a buck.

Capstone Turbine's low-emission and highly-efficient turbines and micro turbines are excellent 'green' products in today's world of expensive oil and gas. The demand is there for the product, and I don't see that demand going away anytime soon. That keeps me confident in this investment. If a company has a good product with long-lasting demand, the stock price usually follows. I feel the same about CSUH.OB.

As the orders for Capstone's low-emission microturbines started pouring in, followed by a slew of Press Releases, the CPST stock price began rising.

Capstone and it's stock got some exposure when Jim Cramer pumped it on his MSNBC show, 'Mad Money'. Usually when Jim pumps a stock, it's good to wait at least a week to buy it because investors will jump the gun and immediately buy-in on his pump. Short sellers will then short at the high and the stock price will drop so the shorts can make their money. It's hard to believe Cramer has that kind of influence, but he does.

On the other hand, if I own a stock that Cramer pumps, I'll usually take advantage of the pump and sell into the spike. I'm not crazy about doing this, especially on a stock like CPST that I have for the long term and just want to buy, hold and forget about it, but it's not worth passing up a nice percentage increase when you'll be able to buy back in at a lower price. It's free money.


Since the Cramer pump, CPST has been slowly retreating, and right now it's low enough where it's a screaming buy for my portfolio, as is SIRI at it's current price.

The reasons for the drop in price may be related to the drop in oil, as companies aren't as quick to look for alternatives when they can afford the oil guzzling products that are more easily accessible, however, I believe the drop could be attributed to the drop in oil price, the down market and a lack of interest in the stock right now. Traders look to trade in these volatile markets, not leave their money sitting in a dead-for-the-short-term-stock when they could be making money elsewhere. That's fine with VFC, because I like to accumulate when no one else is paying attention.

Capstone is still at least a couple of years away from turning a profit, according to a recent quarterly report, but the orders are in, the backlog is huge, and the company is managing to fulfill those orders ahead of schedule.

With the Western world looking at fuel efficient, low emission power sources, I haven't found a company with a better risk-reward bang for the buck than Capstone.

The current market conditions being the way they are, there will be plenty of chances to trade in and out of CPST in the near future, if that's your cup of tea, but as a long term hold, I can see this stock trading at at least five times it's current level within the next few years. I think it could go even higher longer-term down the road, barring any unforeseen events.

The product is strong, the demand is strong, and the stock price is low.

I'll be grabbing CPST shares at any price below two bucks.

We've got an excellent long-term hold here, in VFC's opinion.

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Thursday, September 11, 2008

Celsius (CSUH.OB) Launches Green Tea!

Celsius, the world's first energy drink that burns calories recently released it's tow Green Tea flavors, Mango-Peach and Rasberry Acai, and I just received my first case today. I was pleasantly surprised with the taste of the new product and I have confidence that Celsius' Green Tea will have no problem catching on. It's that good.

Celsius, now offers the non-carbonated Green Tea as an alternative to their five flavors of carbonated drink.

Although Celsius is not Blooming in the Bloom stores, as advertised, I believe that Carl DeSantis means business and will help propel this small company and it's product onto the national scene.

Fans of the Celsius drink and investors in the Celsius stock (CSUH.OB) should expect bigger things as the company prepares to launch a nationwide advertising campaign.

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The Green Tea flavors are delicious, a great alternative to the carbonated drink, and it passed the wifey test; as my wife proclaimed that the new flavors were fabulous. For those that know my wife, she's not easily impressed, so I was pleasantly surprised when she responded so well to the new product. If they pass her taste test, hat tells me that America will love it - but America needs to know about the product before they can taste it, try it and fall in love with it.

That's where Carl DeSantis and the promised national adverstising campaign come in.
Once people know about Celsius, beyond the scope of simple word of mouth, the product should really take off. DeSantis has invested a lot of money into Celsius, and he should use his foothold in the nutrient/supplement business to bring Celsius to the forefront of the 'healthy alternative' and weight loss genre. It's my belief that the company is waiting for the Green Tea to gain some traction before the advertising goes national. Once the distribution is in place, the advertising should follow.

I expect some more insight during the next conference call.

CSUH.OB is trading around seven cents right now, even dipping into the six cent range wich raises some worries, but it's the product, not the stock price, that keeps me interested. The product is just too good to not take a chance with the stock and in VFC's opinion, we're a national advertising campaign away from seeing the stock and the product take off.

Regardless of the long term investment, every few months we seem to get at least a double in stock price for a short time and another one of those spikes would be a great time to sell shares that were bought in the seven cent range, but VFC is keeping a solid base in place for an unexpected run-up.

I'm also still sceptical about how many stores are re-ordering, and I still believe that this next conference call will give us some better insight into this; the money from the overseas order that counted as revenue last quarter will not be there this quarter, so lets see what kind of numbers the company is putting up.

In the meantime, I say go out and try that Green Tea, it puts Enviga's Green Tea to shame!

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