Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?

To: Dauntless who wrote (491)	1/1/1998 2:52:00 PM
From: Dauntless	Respond to of 834

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 (491)	1/1/1998 2:54:00 PM
From: Dauntless	Read Replies (1) \| Respond to of 834

FDA info #2 More goodies from the FDA web site: Go to the following FDA website fda.gov I urge you to browse around , but make sure you look at the link "Benefit vs Risks: How the FDA Approves New Drugs". There you will find the following: ================================================================== FDA participates actively in the drug development process, seeking to provide clear standards and expectations. Sponsors are encouraged to meet with FDA, Temple says, at an "end of phase 2 conference" before carrying out the large-scale controlled clinical trials. (For information about the various phases of drug study, see "Testing Drugs in People.") At this conference, FDA gives advice about the design of the sponsor's study plan to ensure that the trials will be acceptable. As Temple puts it: "We try to find and eliminate flaws in the individual studies and overall development plan that we know will give us trouble later on in the NDA review. We don't want people to carry out a large study that has no chance of being considered adequate and well-controlled." FDA also provides advice, he says, in the form of guidelines on how to study particular classes of drugs and on how to submit and analyze data in a marketing application. In addition, to ensure that institutional review boards meet FDA's rules for the protection of the rights and welfare of research subjects, the agency routinely inspects the boards every five years. "We may go more often, if there are problems," says Frances O. Kelsey, Ph.D., M.D., director of FDA's division of scientific investigations. ================================================================== Now, how well does this description of the process fit with the accusations that the TXB Clinical trials were a sham, obfuscated, statistically insignificant, etc. How did TXB ever complete Phase III trials? Once again, real information from - as Al Gore would say - "the controlling legal authority". Or as I submit, from the horse's mouth, instead of ..... well... let's just say.... the other end of the horse.