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Biotech / Medical : Aviron -- Ignore unavailable to you. Want to Upgrade?

To: Dennis who wrote (442)	12/11/1998 4:11:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 645

Yes there is some new news in the release, but nothing unexpected. The issue (first disclosed a while back) was that the vaccine used in their trials was manufactured in a different plant than the company planned to use for production. The FDA not unreasonably wanted confirmation that the product from the new plant was as safe and effective as that used in the trials. Hence the company plans to do some bridging trials in Australia during their flu season, which is 6 months offset from here. These trials will hopefully demonstrate the equivalency of the products. The schedule they have now announced is what was generally anticipated when the production issue was first announced. Peter

To: Dennis who wrote (442)	12/11/1998 5:00:00 PM
From: Copeland	Read Replies (1) \| Respond to 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