Aviron Message Board - Msg: 6797273

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Biotech / Medical : Aviron

AVIR 3.260

+0.3%

Nov 7 9:30 AM EST

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To: Dennis who wrote (442)	12/11/1998 5:00:00 PM
From: Copeland	Read Replies (1) of 645

I thought it was rather clear. The company has been forced by the FDA to conduct a minor study concerning the efficacy of the vaccine since its formulation has changed from the vaccine used in the clinical studies. As a result, Aviron will be delaying submission of their PLA until the study is concluded and the results are analyzed, which, according to the company's estimates, will not be until summer of autumn of next year (the PLA that is). Add on another year for FDA evaluation and it looks as if Aviron won't be releasing FluMist until 2000 or 2001. The FDA has not rejected FluMist, but rather upped the requirements for review. Best, Copeland

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