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

To: Hank who wrote (3818)	5/3/1998 12:21:00 AM
From: LoLoLoLita	Respond to of 7041

Hank, Agree fully. Further, if ZONA has a poster presenting those results without a full explanation of how they were obtained, it could well be interpreted by FDA staff as ZONA "promoting" a drug without supporting scientific data, a potential violation of FDA regulations. However, just because this info does not appear to be in the poster itself, there is no rule or custom to prevent a presenter from offering additional information, such as a technical report, to the people walking by. If I was an FDA staffer responsible for handling ED NDAs, I'd be very concerned if ZONA presented these claims without, at a minimum, a detailed written report describing their protocol. Even then. a ZONA/SGP technical report would not be considered to be peer-reviewed, so even with that they might get into problems. I'm sure that at least one FDA staffer will attend the AUA meeting, due to the "Viagra phenomenon." David

To: Hank who wrote (3818)	5/3/1998 12:29:00 AM
From: Linda Kaplan	Read Replies (1) \| Respond to of 7041

Hank: The filing certainly has been delayed considerably, but I personally think they may file in the next few months. Basically there's only so much massaging of their data that can be done, and they'll have to submit it to see if it'll fly eventually. The stock price is inflated due to Viagra but remember how it went up before the patent came through? I expect some of the recent runup is due to expectations of the filing. I think they have to file and that some of the considerable hype on the part of the company, suggesting that the drug will help 30% of the ED population and 40% of the ED population (neither figure is remotely supported by the stats we have) has been to try to prep the FDA, hype the FDA, pressure the FDA to give approval. Lots of hype of Vasomax can be thought to pressure the FDA. I'm not saying it CAN influence them, but why not try? If it was a jury rather than the FDA, they wouldn't be allowed to read the papers. hehe But the FDA probably does read the papers and maybe they can be influenced by the phony info being circulated about Vasomax. Linda