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


To: Dauntless who wrote (1460)1/1/1998 1:55:00 PM
From: Dauntless  Read Replies (3) | Respond to of 7041
 
Mr. Wexler, the Purveyor of Poop, has now taken to filling the TXB thread (as well as the Zonagen thread) with his little messages. In order to accomplish this he now has canned messages that he will post over & over & over........

His information is quite valuable if you believe that the following entities are a part of his scam/conspiracy:

Univ. of Texas Med School
Baylor College of Medicine
TXB Board of Directors
Zonagen Board of Directors
All Clinical investigators @ TXB's trial sites (14)
All Clinical investigators at Zona's trial sites
Pharmaco
SmithKline
Schering
M.D. Consultants for both companies
The FDA reviewers of Phase I, II, & III clinical trials for TXB
The FDA reviewers of Phase I, II, & III clinical trials for ZONA

God knows who is next! Maybe Clinton & Gore - no, I think they'd be more likely to be aligned with the P. of P.

The other interesting fact that he ignores is that there has been almost no insider selling at either of these companies - there's a murder, but there's no body!!!!.



To: Dauntless who wrote (1460)1/1/1998 2:22:00 PM
From: Dauntless  Respond to of 7041
 
FDA info #1

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.



To: Dauntless who wrote (1460)1/1/1998 4:30:00 PM
From: BDR  Read Replies (1) | Respond to of 7041
 
<<Dr. Cooley is well known by the investment community to seek out fraudulent
companies as he desperately needs some extra spending cash.>>

I take it this was a facetious statement but there may be some truth to it. If memory serves me correctly, Cooley was a casualty of the Texas real estate boom/bust a decade or so ago and filed, rather spectacularly, for bankruptcy. I remember a write up about his situation in Fortune. I have no idea what his current financial situation is but one can't just assume.