"If the proposed trial is one-up[sic: one,] against an approved therapy, then I could see the FDA showing more interest in whether there were plausible signs of efficacy."[I did not understand meaning of one-up, sounded like a tennis match or baseball game]
Has that not occurred with PPHM's Phase III trial? Your 2 "if" examples cover PPHM phase 3 trial in either alternative.
{{If you are testing a drug with little in the way of a safety signal in combination with an approved therapy, then I very much doubt the FDA would ever try to second-guess you on efficacy in deciding on a Phase III. So in that context the FDA OK to proceed to a Phase III has little (if any) significance.
If the proposed trial is one-up against an approved therapy, then I could see the FDA showing more interest in whether there were plausible signs of efficacy. }}
Peter, that is exactly what I was saying. Thanks for spelling it out more clearly.
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