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Biotech / Medical : Sepracor-Looks very promising

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To: Biomaven who wrote (3179)6/3/1999 11:11:00 AM
From: Don Miller  Read Replies (1) of 10280
 
Peter or others knowledgeable in FDA workings,

Do you agree these types of FDA letters are "common"? How are they usually resolved?

Must the company concede the issue to FDA, even if data more recent than the original submittal is available?

Have the prior occurrences been as public without the benefit of a web broadcast of the letter?

Does anybody know long have these letters been readable on the web?

Can anybody tell when this letter was placed on the web, and how did you discern the post date?

Don
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