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Biotech / Medical : Biotech Valuation
CRSP 55.11-2.6%Nov 7 9:30 AM EST

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To: Biomaven who wrote (7477)12/11/2002 11:23:04 AM
From: rkrw  Read Replies (1) of 52153
 
If anyone ever gets the chance to, attending these meetings is a true eye opener. You'll realize just how much there is out there that as an investor you would have no way of knowing. Such as why did people drop out of a trial? Was it truly unrelated as the co. claimed? They died, the co. says it was unrelated, the fda begs to differ. Has anyone heard a bio claim a side effect was severe? Why are they always manageable and reversible? So the co. takes the soft stance, the fda always will be more cautious. Tinker with the numbers a little bit, alter the definitions very slightly and all of a sudden a trial goes from statistical significance to completely random, a bust. You have to think like a true devil's advocate and there are very few no brainers that go before panels.

To answer Harold: <<Bexxar is an extreme case: I personally can name no other drug that seems so approvable that has been held back for so long to the detriment of so many for no clearly stated reason.>>

Replagal/Fabrazyme were seen as no-brainers until a few months ago. Now the panel is seen as high risk. (I still think its cruel that the fda hasn't approved them).

I have a small option bet on crxa getting approval. I find it very curious that all of a sudden the fda drops its objections 3 weeks in front of the panel.
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