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Re: biomaven0 post# 189144

Wednesday, 03/25/2015 4:39:40 PM

Wednesday, March 25, 2015 4:39:40 PM

Post# of 257371
{{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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