Zonagen (zona) - good buy? Message Board

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

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To: Tunica Albuginea who wrote (615)	10/5/1997 12:59:00 PM
From: Claud B	of 7041

Perhaps you'd like the real truth. #1. Zonagen is not doing another phase III study. They will be filing an NDA in the 4th quarter. They are completing the long-term carcinogenicity studies (these are done in animals) to supply the data requested by the FDA. #2. MANY patients from their 2 U.S. Phase III studies elected to enroll in the open label studies. Over 1,000 men have enrolled in the open label studies to date. #3. the dose has been established at 40 mg - this was accomplished in the Phase II studies. They are NOT, repeat NOT, doing dose escalation studies. #4. Dr Harim Padma Nathan is NOT currently on their scientific advisory board and hence NOT paid by them. Yes, he has been involved in many studies in this therapeutic field - he is considered an "opinion leader" in the area. He runs "The Male Clinic" in Santa Monica where he treats this problem all day long. (they would love to have him join their SAB as he would bring much to the company.) He also was the driving force behind the BIG impotency meeting in CA in September where every company working in the area presented scientific data. #5 ZONA has always said that the target market for Vasomax is men with mild to moderate erectile dysfunction - incidentally the largest segment of the market. The pivotal trials were structured to eliminate right off the bat anyone who did not have a physical erectile problem - those who "did not need it" were not even allowed in the trials! Perhaps these facts will illuminate you. As an aside, you might be interested to know that during the Phase II dose ranging studies, several men passed out from the placebo(sugar pill.) The power of suggestion, eh? Claud

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