Aviron Message Board - Msg: 16135535

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Biotech / Medical : Aviron

AVIR 3.240

-0.9%

Oct 31 3:59 PM EST

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To: tuck who wrote (610)	7/27/2001 9:19:28 AM
From: Biomaven	Read Replies (2) of 645

tuck, If you look at the details of the study that didn't show significance in reducing febrile illness in adults (AV009), you'll see it was clearly effective in reducing flu-like illness: Any febrile illness: .19 (p-value not significant although about a 10% reduction in illness) Severe febrile illness: .031 (significant) Febrile Upper Respiratory Infection: .011 (significant) CDC-ILI: .0018 (highly significant - this is the CDC definition for flu-like illness) Days taking at least one prescription antibiotic: <.0001 (about as significant as you get). Bottom line is that the amount of flu-related illness got swamped by other minor bugs, but the vaccine clearly worked. Who knows if the panel will see it the same way, but that's my view. I don't like that bit about "There are some manufacturing issues which continue to be discussed," and why on earth hasn't the FDA completed its safety review yet? Peter

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