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Re: Rdunn88 post# 215355

Thursday, 02/01/2018 11:59:56 AM

Thursday, February 01, 2018 11:59:56 AM

Post# of 403226
Recommended reading about probable trial size for ABSSSI.

Brilacidin trial for ABSSSI would require a trial comparable to antibiotic trials. That means a larger and costlier trial than a typical cancer trial. To make things worse FDA has been a wind vane about the sort of trial it wants to see, requiring tightening non-inferiority criteria and, hence, even larger trial one day, then, surprise, saying: "well, maybe not". That flip flopping has pissed industry off and has made them abandon some promising antibiotics.

I recommend enlightening excerpt here.
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