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


To: fred hayes who wrote (1122)1/20/2006 3:54:03 PM
From: Biomaven  Read Replies (1) | Respond to of 1154
 
I didn't listen to the CC, but going on the language used it's hard to see the FDA budging anytime soon. They already have a large study showing the rash was pretty insignificant if you just used the drug for a short time, so it's hard to see what more the company can do.

The trouble is there are rashes and there are rashes. The rashes produced in the studies have all been harmless, but at the back of the FDA's mind is that some drug rashes can be very serious or even fatal. Why the FDA didn't state their position before approving the ABS trials I have no idea, unless something in the trial results worried them.

The company could of course request an AC meeting on this and I think they could have a chance of getting the FDA overruled.

I shouldn't really be speaking without listening to the CC, but I just don't have time to do so.

Peter