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Dynavax Technologies Corporation Message Board

  • timothysoup timothysoup Feb 5, 2013 10:49 PM Flag

    Has the FDA approval date changed?

    This was posted 5 days ago on Investor Place... note the date (Sunday, Feb. 10)

    Dynavax Technologies
    If you like trading binary events like drug approvals, then be sure to mark Sunday, Feb. 10, on your calendar. That’s the day Dynavax Technologies (NASDAQ:DVAX) will get the thumbs up or thumbs down from the FDA regarding its hepatitis B immunization drug Heplisav.

    The stock has been eerily tame for a biotech name just a couple of weeks away from an approval decision. Most of the time, traders start jockeying a few weeks ahead of time, just to make sure they get a good price on their trade, and to beat others to the punch. Perhaps the lack of trading interest now should be an omen. Or, maybe the market’s indecision just reflects the advisory panel’s.

    Although the FDA’s pre-PDUFA advisory committee — the committee that makes recommendations to the FDA’s final decision makers — voted favorably (13 to 1) when asked if Heplisav was effective, the same committee also voted against (5 to 8) the drug clearly being safe enough to approve it.

    The odds still slightly favor an approval, and the fact that the hepatitis B market is relatively under-served helps. Still, there’s a slight shadow of doubt here that could work to speculators’ advantage.

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