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Biotech / Medical : Zonagen (zona) - good buy?

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To: BDR who wrote (6481)5/6/1999 11:51:00 PM
From: BigKNY3   of 7041
 
Dale <<"VASOMAX is currently under review at the FDA; the PDUFA (user fee) deadline is July 14, 1999. However, an amendment to the original NDA submission was filed in January 1999, which could extend the user fee deadline.">>

Dale: Under the User Fee Agreement with the pharmaceutical industry, the FDA is required to inform Schering the status of the Vasomax NDA by 7/14/99 (one year after the submission). However, since additional data was apparently submitted in January 1999, this deadline may be extended up to January 2000.

BigKNY3
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