Replies to post #172013 on Biotech Values

[Robert C Jonson]

I said essentially the same thing in #msg-88106650.

Maybe I forgot. :-)

Or maybe I also wanted a second opinion.

Also, in light of this discussion/opinion, I don't know why you would ever have said the FDA would "never approve a phIII based on this data," or words to that effect, if you knew the only bar was safety?

[Robert C Jonson]

After thinking about your and Peter's comments about the FDA and phIII trials, I found this on an FDA website:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm

Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.(emphasis mine)

So it would seem efficacy is at least stated to be part of the FDA process to allow a drug to proceed to phIII.

Bob