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

To: Linda Kaplan who wrote (6019)	12/30/1998 2:51:00 AM
From: VLAD	Read Replies (1) \| Respond to of 7041

Linda, Does the FDA use any set guidelines in terms of placebo compared efficacy in order to determine if a drug is actually showing a significant effect above placebo? If so what are the percentages? I understand that in clinical trials Vasomax only had a small improvement over placebo. If this is so why should the FDA approve a drug that is insignificantly better than placebo? This links shows only a 13 to 15% improvement above placebo. Is this considered significant enough to allow this drug approval for the treatment of erectile dysfunction?? www3.techstocks.com Also, I understand that Vasomax can be very dangerous in men with cardiac problems: www3.techstocks.com www3.techstocks.com I believe that in order to be granted FDA approval a drug has to be proven safe and effective. Based on the information presented to me so far, it appears to me that Vasomax is contraindicated in the cardiac patient and is not much more effective than a sugar pill. Given these fact, I see no reason that the FDA would be inclined to grant approval.