I have some call options.. At the risk of being skewered by optimists... I am not sure if I did the right thing. Anyone know any biotech company that was turned down by the advisory committee only to be approved by the FDA? I really can't think of any. If you of any please let me know. I am interested. I can think of PLENTY of companies who won the advisory panel but lost the FDA approval, however not the other way around. I do think that this will finally be approved but my guess is a new trial.
According to an October 2010 analysis, the FDA has heeded the advice of its team of outside medical experts an estimated 76% of the time since 2007. In most of the cases where the agency’s final decision on a drug does not match that of the advisory committee, it is when regulators have said ‘no’ to a drug recommended by the advisory panel. But in three cases, the FDA overruled its advisory committee to give a drug the thumbs up. And in two of these cases, the drug exhibited at best, modest benefits.
It happened again: the US Food and Drug Administration has ignored the advice of an advisory committee by placing the drug Daliresp, described by at least one committee medical expert as “meager”, on the market.
Thanks for the response stocktech. Finally an intelligent answer.. Which unfortunately does not bode well for my speculative option. I do hope it gets approved though even if conditionally. Ultimately it will because it is effective and no serious adverse events have been described so far.