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

To: BigKNY3 who wrote (6480)	5/6/1999 11:24:00 PM
From: BDR	Read Replies (2) \| Respond to of 7041

Mr. BIG- Thanks for the post. Facts are so much better than fantasy and there has been plenty of the latter on this thread lately. Can you explain the following passage from the SSB report? Can we deduce that the FDA will act by July 14? If the fee isn't paid the process starts again? "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."

To: BigKNY3 who wrote (6480)	5/7/1999 10:25:00 AM
From: Linda Kaplan	Read Replies (3) \| Respond to of 7041

Thank you for posting that comprehensive, balanced, report. There are a lot of negatives in this report, and I was unaware of many of them. It sounds like it's possible that the FDA decision will not be by mid-July but by January. And there are plenty of side effects to Vasomax, despite claims otherwise in this thread. Tachycardia and fainting are not trivial. And the nausea, vomiting and diarrhea, which some posters here denied, is back in the pot. I still don't think that nausea, vomiting and diarrhea are conducive to a pleasant sexual experience. Silly me. Plus, the nitrate question is still open in regard to Vasomax, since people on them were excluded from the trials, and a secret separate study is being done or was done on that issue. Certainly if initial dosage of Vasomax must be provided by a physician in office, that would be a deterrent to sales. I don't know why there would be better efficacy in an uncontrolled study than in a study that was controlled by placebo. Do you? Linda