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Robert C Jonson

12/31/13 6:56 PM

#172037 RE: biomaven0 #172033

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

Peter, are you aware of any submissions a company submitted for phIII that the FDA failed to register, and if so, was it only for safety reasons?

Or do the companies keep such disclosures confidential?

Thanks for providing the example of antineoplaston.

Bob