Avid Bioservices Inc (CDMO)

[entdoc]

Moby, the statement,"...the FDA and bigfinance respond only to sufficiently large, randomized trials..." is erroneous. There ARE other avenues to FDA approval, many.
In regard to; "Where [what] is the threshold for a sufficiently large, randomized trial publicly documented?"
No documentation exists as such, but the parameters driving test- subject size is related to statistical method. That is, at what "confidence interval" are you comfortable.
The "numbers" generated in India PPHM trials reported at ASCO were said to be good to the .05 confidence level. Thus the observed results for Bavi in India, if they had occured from chance, could have only done so 5 times in a hundred. The .05% confidence limit is not generally considered good enough, but a barometer, and an easily duplicable number, and duplication is the name of the science game. Bavi has earned undisputed right to confirm its numbers in this country, a great leap forward. So pick your "confidence level," and given the same numbers generated in India, a statistician can tell you the patient trial cohort size.

Does Peregrine's "flagship gold-standard" (AKA repeat phase II) trials exceed that threshold?