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

To: F. Jay Abella, III who wrote (4170)	5/15/1998 11:41:00 AM
From: Linda Kaplan	Respond to of 7041

Wowser. Did you write this: "What they don't tell you - Zonagen. Where to begin? First notable; their marketing partner, Shering Plough, also a presenter at the conference, deferred all discussion of ZONA's erectile dysfunction product, Vasomax, to ZONA. Guess they don't want to be named co-defendants in the dozen-or-so lawsuits waged against ZONA alleging fraud among other things. As for the actual ZONA presentation, the CEO stated that an NDA will be filed before the end of June 98, and will undergo at least a year review at FDA. He also stated that SGP made ZONA revamp its style for NDA submissions, thus the delay in the 350 volumes going to FDA. Didn't we write this to the bulls on the ZONA SI thread last year? Surprisingly, the CEO only mentioned Vasomax for male erectile dysfunction for 5 minutes of the 25 minute discussion. He did go on to say for an equal amount of time that they are looking to test Vasomax in conjunction with other MED drugs. Hmmm. At no point did he mention the pharmacokinetcs of Vasomax or comment on its time to onset of erection. In the breakout session, we asked him why he omitted this key discussion from both his talk and his white paper, issued in December 1997. With tape recorders rolling, he said that the white paper clearly states that the onset of erection is 30-45 minutes. We are still looking for that discussion and invite anyone to cite chapter and verse of where this parameter is mentioned (ZONA only talks about "rapid onset of action" on page 4 - not exactly a quantitative measure of anything). We equate omission of this discussion, or any mention of the pharmacokinetics of oral phentolamine, to be a deal breaker. The problem is that since the FDA submission is six months later than when ZONA said it would be filed last year, the FDA does not have to give it priority review since Viagra is already approved. As such, a lot can happen with this stock in the interim, especially given that ZONA still can buy back up to $6mm worth of shares itself. The ZONA situation accentuates further that the gap between the fundamentals of a company and the price of its stock can assume arbitrary breadths until the FDA day of reckoning. Don't believe me? Answer this question. What do ERGO Sciences and Frank Sinatra have in common today? "

To: F. Jay Abella, III who wrote (4170)	5/15/1998 12:10:00 PM
From: Diamondcutter	Read Replies (3) \| Respond to of 7041

The time needed to file the FDA is a concern to me. Isn't Pharmaco (sp?), the number crunching firm for ZONA, a pretty large and respected organization--and therefore one which would be expected to format the application in a "style" agreeable to SGP the first time? FJA, I don't understand the "onset" issue. Are you indicating there is some problem with the time to react for Vasomax? Or just unhappy that the time data is not in print? If the CEO says its in the white paper and its not, that is one thing, but it is more important to know the data. FYI, rumors still exist that SGP is limiting what ZONA can say publicly for competitive reasons. Obviously, bears will say this is not true because they can't comment favorably on a product which doesn't work (HA! beat you to it). However if the "muzzle" theory is true, it could explain why there is a limited flow of positive news Also, there is a report that 1/3 of Viagra users desensitize to the product after about a year of use. Any medical comments regarding this and whether the same would happen for Vasomax? Diamondcutter