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

To: tom pope who wrote (7596)6/16/2004 9:10:06 AM
From: quidditch  Read Replies (1) | Respond to of 10280
 
<<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.>>

And, from the release the corollary to that statement:

<<Sepracor expects, based on discussions with the FDA, that the FDA will characterize the resubmission as a Class 2 resubmission.>>


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