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Biotech / Medical : Sepracor-Looks very promising
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To: tuck who wrote (7586)6/14/2004 3:12:32 PM
From: Biomaven  Read Replies (3) of 10280
 
So where is the re-filing? It's no longer "late May or early June."

The only positive reason for a delay might be their brief mention in response to a question at the Annual Meeting of the (small) possibility of separating out the 1mg dose from the 2mg and 3mg doses in their application, hoping to get a Type I review for the more important 2mg and 3mg doses and a Type II for the much less important 1mg dose. Doing this would certainly delay the re-filing some, but it would be clearly worth it. Pretty long-shot though that this is the reason for the delay.

But clearly this re-filing has dragged out longer than they had anticipated even a few weeks ago.

Peter
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