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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: BDR who wrote (6481)	5/6/1999 11:51:00 PM
From: BigKNY3	Respond to 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

To: BDR who wrote (6481)	5/7/1999 1:10:00 AM
From: Bruce Rosen	Read Replies (1) \| Respond to of 7041

<< Facts are so much better than fantasy and there has been plenty of the latter on this thread lately.>> Indeed they are and there has been plenty of fantasy on this thread for a long, long time. To her credit, the SSB analyst did clearly identify the fact that much of what she wrote was her opinion. Many of the facts she reported were actually pretty positive about Vasomax. The only numbers I found to be negative was the incidence of tachycardia in the 80mg dose. There did not seem much difference in efficacy between the 40mg and 80mg doses. Perhaps there is a better chance of approval for the 40mg dose. She did say more than once that if Vasomax did not have the same problem with nitrates as Viagra, it would be a significant advantage for Schering, but Schering had not made that information public. More "stealth marketing" no doubt. She also never discussed the Mexican sales of Vasomax. I guess she doesn't consider that an important enough issue to mention. BigKNY3, nice to see you here. You have always been a fair minded person of reason, even if you are partial to Pfizer in this coming battle. Remember, this is a large enough market for both drugs to prosper. Good luck to all! Bruce