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Biotech / Medical : Aviron
AVIR 3.260+0.3%Nov 7 3:59 PM EST
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To: Arthur Radley who wrote (330)9/1/1998 2:50:00 PM
From: Gerald Walls  Read Replies (1) of 645
 
From the news, it appears there is a problem with manufacturing, but could be more.

From the news release there doesn't appear to be a problem. The FDA just wants more info.

Fortunately I sold this for a profit a couple of weeks ago.

biz.yahoo.com

The company on Monday said the U.S. Food and Drug Administration had not accepted its marketing application for FluMist because the agency needed more information on the manufacturing processes and the facilities where the vaccine will be manufactured.

...

The company said Monday that the agency was not seeking any additional information on safety or efficacy of the vaccine.

But it added that the FDA might require another clinical trial to ''bridge'' from the manufacturing process used for producing small amounts of the vaccine in the Phase III trial to the process planned for producing larger commercial supplies.

...

'The real nuts and bolts of FluMist, its safety and efficacy, do not appear to be an issue,'' Van Den Broek said.

''What Aviron needs to show is that its manufacturing situation is in order -- that it can replicate the same product in far larger amounts. And companies generally resolve these types of manufacturing issues,'' Van Den Broek added.
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