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

To: Bill Wexler who wrote (1512)	1/6/1998 9:42:00 PM
From: BigKNY3	Respond to of 7041

Bill, please move the needle! BigKNY3

To: Bill Wexler who wrote (1512)	1/6/1998 10:41:00 PM
From: Dauntless	Read Replies (3) \| Respond to of 7041

Willie boy's lie # ?? - take you pick. "Vasomax will never be approved by the FDA" - or something. For those of you who are maybe not in the business & wonder about some of the recent claims on this site, I thought this info might be enlightening. The following is a brief description of the clinical trials process & the "survival rates" for drugs at each phase. This info can be found at: fda.gov ==================================================================== Testing in Humans Phase 1 Number of Patients: 20-100 Length: Several months Purpose: Mainly safety Percent of Drugs Successfully Tested: 70 percent Phase 2 Number of Patients: Up to several hundred Length: Several months to 2 years Purpose: Some short-term safety but mainly effectiveness Percent of Drugs Successfully Tested: 33 percent Phase 3 Number of Patients: Several hundred to several thousand Length: 1-4 years Purpose: Safety, dosage, effectiveness Percent of Drugs Successfully Tested: 25-30 percent For example, of 100 drugs for which investigational new drug applications are submitted to FDA, about 70 will successfully complete phase 1 trials and go on to phase 2; about 33 of the original 100 will complete phase 2 and go to phase 3; and 25 to 30 of the original 100 will clear phase 3 (and, on average, about 20 of the original 100 will ultimately be approved for marketing). ==================================================================== NOTICE - Out of 100 drugs that start the clinical trial process, approximately 25 - 30 will clear Phase III testing and "about 20 will ultimately be approved for marketing" - that's 66.7 - 80% of those finishing Phase III. Some time ago I estimated a slightly higher percentage than that (I think I said 85-90%) & I still think that's correct for certain circumstances - low side effects, no alternative therapies, entity submitting the NDA (large pharma does better than little guys),etc. In any event, based on FDA supplied statistics, Vasomax appears to have a pretty good chance of receiving FDA marketing approval - especially with a big pharma partner handling the NDA - they don't just provide $ & distribution. For what it's worth - an opinion, but backed up with FDA published data (read: real proof) - for a change. I urge anyone that's interested to look around the FDA link I provided - lots of "stuff" to help you evaluate the information provided, by some, on this site.