Aviron Message Board - Msg: 11955316

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Biotech / Medical : Aviron

AVIR 3.250

+0.5%

3:59 PM EST

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To: Edscharp who wrote (502)	11/16/1999 7:16:00 PM
From: Copeland	Read Replies (2) of 645

This is disappointing of course, but it is only a delay. It appears that Aviron is intent on dotting all the i's and slashing all the t's before filing the BLA. It's a delay that probably could've been avoided without stabbing the stock holders in the back. The original BLA was rejected because the Flumist batch that Aviron used in the original clinical trials was made up in a way that differed from the process Aviron submitted to the FDA. No bridging study was done to compare the efficacy of the two batches and Aviron got what it deserved -- a rejection from the FDA. Now they did the bridging study and Aviron states publicly that all's well and they're on tract to submit the PLA by the end of fall (which theoretically could've been up to mid-December). Then suddenly this announcement that there are questions about manufacturing again (from the news release: "The schedule change is due to issues that arose in routine validation tests during the vaccine manufacturing process.") Shouldn't all of that been taken care of earlier, like before the bridging study?

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