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Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (1119)1/20/2006 10:35:31 AM
From: Biomaven  Read Replies (2) | Respond to of 1154
 
opinion that demonstrating an acceptable risk versus benefit profile for FACTIVE in ABS was not feasible, given the FDA's view of the potential risk of rash in those patients.

I don't like this, and so I sold my position this morning. Doesn't sound like the FDA has an open mind on this issue, and that means the drug will always have something of a cloud over it from the perspective of off-label use and label expansion and hence from the perspective of a partner.

Personally I think the FDA is wrong here given the studies the company did on the rash.

Peter