Sepracor-Looks very promising Message Board

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Biotech / Medical : Sepracor-Looks very promising

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To: Biomaven who wrote (7587)	6/16/2004 7:36:33 AM
From: tom pope	Read Replies (1) 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.

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