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Biotech / Medical : Biotech Valuation
CRSP 55.08-2.9%Dec 26 9:30 AM EST
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To: scaram(o)uche who wrote (23475)4/17/2007 6:27:15 PM
From: Biomaven  Read Replies (3) of 52153
 
On the other hand this is indeed a new and different standard - instead of "safe and effective" we have a somewhat higher standard required for this class. I'm not saying that isn't reasonable in this particular case, but it does raise the question of whether not approving a drug that is equally effective and of at least comparable safety to other approved drugs in the class is even within the FDA's legal mandate.

There are anecdotal claims of idiosyncratic efficacy within this class - folks that claimed that Vioxx was a miracle drug for them compared with other NSAIDS. Maybe the AC would have come to a different conclusion if presented with a trial that actually demonstrated that.

From a pure risk/benefit standard (as opposed to a legal one) I would have voted the same way as the AC. Any new drug has some unquantified risk, and given the 20-or-so other NSAIDS already on the market and the Vioxx debacle it doesn't seem like it's worth the risk, even if that risk is relatively low.

Peter
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