Aviron Message Board - Msg: 6796593

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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 4:11:00 PM
From: Biomaven	Read Replies (1) 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

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