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Biotech / Medical : Biotech Valuation
CRSP 53.50-1.3%3:59 PM EST
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To: NeuroInvestment who wrote (10749)3/1/2004 3:33:05 PM
From: Biomaven  Read Replies (1) of 52153
 
Thanks for the CRIS update, Harry.

On SEPR, resubmitting the NDA is I believe just shorthand for resubmitting with answers to the questions raised by the FDA in their approvable letter. These answers are such that they will almost certainly fall into the "Class 1" resubmission category, with a two-month clock on the FDA. Thus adding the 1-3 months that SEPR says they will need for their response, we get 3-5 months before approval. That puts us in the May-July time frame by my reckoning - i.e., 2Q-3Q.

SEPR promised to tighten up their 1-3 month response window once they have spoken with the FDA later this month.

Peter
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