Thursday, May 15, 2008

DNDN in the News Again

With the recent rise of CEGE, due to its partnership with Takeda, it’s easy to overlook Dendreon (DNDN) and the fact that they should be releasing interim Phase III results for their Provenge trial, which could lead to approval if the results show an extended survival rate for the prostate cancer patients.

I’m pretty heavily loaded in Dendreon Jan 2009 options, which I gobbled up after the big drop last May with some of the profits I took after the big runup last march. If results are positive, however, it’ll be a nice payday, but at this point I’m leaning towards not expecting too much, so I’ll probably start selling those options on any spikes we get beforehand.

On that note, some more attention will be drawn to Dendreon and Provenge on May 30th when Care To Live will organize a multi-state protest against the FDA’s decision to not approve Provenge last year, after their very own advisory panel recommended approval.

The panel voted 17-0 that Provenge was safe and 13-4 that Provenge was effective.

When the FDA decided not to approve at that point, many prostate cancer patients, and patient activists, lobbied against that decision, and continue to do so now. Two doctors that were on the panel were charged with conflicts-of-interests, since some of their financial investments were tied to a company with a competing prostate cancer drug.

Now it’s a waiting game, waiting on the interim results of the current trial. Dendreon CEO re-affirmed his pledge to release the news in second half 2008, but did not get any more specific than that.

The only other mover for the stock price would be news of a partnership or to a lesser extent, news of a New Drug Application in Europe, or even Russia, where Antigenics received approval for their own cancer ‘vaccine’ Oncophage last month.

Dendreon, at this point, is a short-term hit-or-miss. The stock price depends on the outcome of the interim results. I still like the risk-reward, because as we saw last year, the payoff could be huge. On the other side, the stock will sink on negative interim results and the wait for final results could take up to two years. I do believe that Provenge will eventually be approved, as I believe the FDA and the rest of the world will start accepting these cancer vaccines as standard treatment, especially for those with late-stage cancers that are not able to be effectively treated with chemo and the likes.

I also believe, as I’ve previously stated, that we are on the verge of some big things in the form of cancer treatment, and these vaccines are just a start.

In the meantime, I’ll sell some of my call options on any significant rise in price, and I’ll buy some more of the stock on any significant dips, but investing here is not for the faint of heart.

Gotta have some cajones to go with DNDN right now, but if you hit, you’ll hit big. (Hanesbrands Inc.)

The Wine Messenger

1 comment:

  1. VFC, if you're not a journalist or in the media, you need to consider such an avocation; you wrote about the Provenge saga with clarity, concisely and told the story fairly and accurately. It is a well-balanced story you've told.


    To aid those not up-to-speed on exactly how badly one doctor’s Conflict of Interest situation appears to be in the FDA Provenge Advisory Committee meeting, take a look at these alleged COI for Dr. Howard Isadore Scher of Sloan Kettering in NYC.

    In order to sit in judgment of Provenge, Scher certified to the FDA that he had 3 Conflict of Interests. These 17 (SEVENTEEN) have been found on the internet for Scher.

    *** NOTE particularly items 1 & 17

    1. NOVACEA: Grants & Research support; STUDY CHAIR of DN-101 ;

    …. and DIRECT COMPETITOR to Provenge

    2. GPB BIOTECH: Financial Conflict of Interest per Scher in MedPage

    3. PHARMION: Financial Conflict of Interest per Scher in MedPage

    4. SANOFI-AVENTIS: Grants & Research support

    5. BRISTOL MYERSSQUIBB: Consultant, Grants & Research

    6. MILLENNIUM PHARMCEUTICALS: Grant of Research support

    7. COUGAR BIOTECHNOLOGY: Principal Investigator; Advisory Board;

    8. INNOVIVE PHARMACEUTICALS: Principal Investigator

    9. INFINITY PHARMACEUTICALS: Principal Investigator

    10. BIOGEN-IDEC: jointly held stock with spouse

    11. PFIZER: jointly held stock with spouse

    12. GENTA: Scientific Advisory Board (as of Mar 6, 07; since removed but cached)

    13. CONFOMA THERAPEUTICS: Scientific Advisory Board

    14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

    15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

    16. MEDIVATION, INC: Principal Investigator MDV3100

    …. Board of Directors
    …. Advisor
    …. Novacea INVESTOR (direct competitor to Provenge)

    Despite the above being reported to the Health & Human Services investigate office and the FDA investigative office, nothing has been done for almost a year to investigate these allegations that Scher may have violated the law by his apparently failure to disclose ALL his COI.

    However, when two individuals sent flowers to the FDA Commissioner last month, the FDA sent 2 Investigators--within 1 business day--to the florist who delivered the flowers in order to get the names and other information about those who sent Dr. Andy flowers.

    Now, that's genuine justice, isn't it?

    Finally, remember that Provenge is a treatment for TERMINAL prostate cancer victims... it's not about an aspirin, a vitamin or an OTC supplement... this is about life and death.

    83 men die daily from prostate cancer and some 30,793 have died just since last May 9th when the FDA postponed Approval/Conditional Approval for Provenge... a treatment all AC members voted to be "safe" by a 17-0 ballot.

    Approve Provenge NOW and, Dr. Andy, fulfill your duties of office or resign.

    Tony F


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