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


To: Dennis who wrote (260)7/1/1998 12:30:00 PM
From: Gerald Walls  Read Replies (1) | Respond to of 645
 
Now, how long does it usually take for the FDA to approve the PLA?? Is there any chance we could see this hit the market THIS flu season??????

Two newsletters/analysts have speculated that, partly because of the NIH link, the FDA would give a fast-track approval and the drug would be ready for this season. This is possible but would be unusual. Fast track is usually for drugs that can immediately save lives where there are almost no alternatives. (At least that's the way I the lay person understand it.) We're probably looking at next flu season.



To: Dennis who wrote (260)7/1/1998 2:12:00 PM
From: SJS  Read Replies (1) | Respond to of 645
 
Dennis,

I don't know the exact timeframe for this action, but some I've talked to think that since there trial numbers are already so overwhealmingly positive, that the FDA will "fast-track" the product in time for the 1998-1999 season. I have no personal experience with the process or if this is a reasonable approach, so I really don't know.

Maybe someone else who knows alot about this can chime in here...

Would like a pullback to buy some more. I think I will get a close under thirty for options expiration in a couple of weeks.