Replies to post #172032 on Biotech Values

[biomaven0]

This Phase III trial was registered despite very little in the way of convincing evidence of efficacy and multiple warnings from the FDA:

http://clinicaltrials.gov/ct2/show/NCT01260103?term=antineoplaston&phase=2&rank=1

(There had previously been multiple single-arm trials with isolated claims of efficacy in a few patients).

http://en.wikipedia.org/wiki/Burzynski_Clinic

http://www.randi.org/site/index.php/swift-blog/2263-fda-releases-burzynski-clinic-inspection-notes.html

So yes, normally in order to proceed to a Phase III trial a company would need to see convincing evidence of efficacy. But it's not something the FDA will enforce - the FDA basically takes the view that if a sponsor wants to spend the money to enroll a trial they can, provided safety has been established.

My only point here is that entering Phase III is, by itself, not an endorsement by the FDA of efficacy. It is a modest endorsement of safety.

Peter