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Biotech / Medical : Biotech Valuation
CRSP 58.15+5.4%3:59 PM EST

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To: Czechsinthemail who wrote (6422)5/23/2002 5:04:19 PM
From: Biomaven  Read Replies (1) of 52153
 
I think the chances of the FDA overturning an 8-2 decision are small. (Note I'm speaking here without the benefit of seeing a transcript of the discussion.) But they certainly are still capable of giving BGEN only an approvable letter subject to further testing (like with Cialis) - I don't think this is likely though. If they do approve outright, they will almost certainly require some Phase IV testing.

The crossbar for other drugs does get raised some - they can no longer simply point to MTX and cyclosporine as the nasty alternatives. However it's also encouraging that the Panel was prepared to not get freaked out by the safety concerns. It's also good for MEDI-507 in that they didn't throw Amevive out simply because there was T-cell depletion. (As Rick I believe has said, you want some T-cell depletion in psoriasis).

Peter
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