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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (7587)	6/14/2004 3:44:35 PM
From: Icebrg	Read Replies (2) \| Respond to of 10280

>>But clearly this re-filing has dragged out longer than they had anticipated even a few weeks ago.>> How do we know that they haven't filed yet? Erik

To: Biomaven who wrote (7587)	6/14/2004 5:35:41 PM
From: jayhawk969	Respond to of 10280

They have also released a lot of "study" information including extended use, drug interaction studies, etc. in the last couple of weeks. My gut is that they are "negotiating" with the FDA and they are still hoping for something better than a Class II (ala your "possibility") or they are now incorporating new data to smooth out the approval process. I have often been wrong on this company but right now I do not expect any negative surprises. J.D.

To: Biomaven who wrote (7587)	6/16/2004 7:36:33 AM
From: tom pope	Read Replies (1) \| Respond to of 10280

So where is the re-filing? It's no longer "late May or early June." Right here, Peter. NEW YORK, June 16 (Reuters) - Sepracor Inc. (NasdaqNM:SEPR - News) said on Wednesday it has resubmitted its marketing application for its sleeping aid Estorra, saying it has answered questions posed by the U.S. Food and Drug Administration after its original application. In February Sepracor received a letter from the FDA saying it would approve the drug contingent on the company answering certain questions. The company said it has now done that. The agency did not require additional clinical trials. The FDA now has 14 days within which to evaluate the submission to determine if it is complete. If it is, Sepracor said it would expect a decision from the agency on whether to approve the drug within six months.