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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?


To: A.J. Mullen who wrote (108)11/3/2003 12:26:00 PM
From: Biomaven  Read Replies (1) | Respond to of 411
 
Isn't that odd?

The whole situation is very unusual. Normally the AC meeting would be before the FDA issued an approvable/non-approvable letter. But the company/FDA couldn't make the original AC date, and so if the FDA wanted to meet the PDUFA date their only real option was an approvable letter. It wouldn't have made sense to give either full approval or a non-approvable letter in the context of a forthcoming AC meeting.

Peter