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To: Terry Maloney who wrote (232638)4/1/2003 10:33:56 AM
From: reaper  Read Replies (1) | Respond to of 436258
 
terry i think this guy is a little off in his expectations.

they filed the Estora NDA on 3 Feb. what is coming up is notice of acceptance of the NDA (i.e. that the filing is sufficient, data in good form, etc), not the ruling on the drug. i can think of no good reason for the FDA to reject the NDA submission, though it certainly could happen. rejection of the NDA would be a large downside event, although acceptance is just normal course of business. the FDA will likely review Estora on a 10-month timeline, which would mean the decision date is in December 2003. fwiw this isn't expected to be a huge drug (maybe $300-400mm peak sales).

Cheers