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Biotech / Medical : Sepracor-Looks very promising
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To: quidditch who wrote (2389)4/16/1999 3:54:00 PM
From: Biomaven  Read Replies (2) of 10280
 
steven,

I think this is just a warning shot across SEPR's bow, and won't have any impact on their relations with the FDA as long as they behave themselves when promoting the drug.

I think all that happened here was that SEPR, with its first approved drug, was thinking with its IR hat on and not its FDA hat on. Before you have an approved drug, it's fine to discuss the trials and interpret the results in any reasonable manner; once it's approved the standards change abruptly for what the company can claim.

Note that this wasn't a "warning letter" which is more serious. Letters like SEPR got are pretty common.

Here's the site where you can see them:

fda.gov

Peter
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