Sepracor-Looks very promising Message Board

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Biotech / Medical : Sepracor-Looks very promising

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To: Don Miller who wrote (3156)	6/2/1999 1:05:00 PM
From: Biomaven	Read Replies (2) of 10280

Don, The issue here is not whether the FDA will accept data from European tests, but whether SEPR would have the right to use the data that UCB has collected. This is purely a contractual issue between the two companies. The detailed data from NDA applications is not public as far as I know. Don't know how much of it (if any) you could get with a FOI request. The FDA will of course accept data from good quality international trials. I guess they'd look askance at solely non-US data, though, although they probably wouldn't admit this. Peter

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