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
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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).
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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.
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