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Re: Hazelhurst post# 225850

Tuesday, 04/24/2018 9:21:49 AM

Tuesday, April 24, 2018 9:21:49 AM

Post# of 403074
I think AA would be very iffy. Efficacy in UP might be good enough i.e. astounding, I can't say the same about efficacy in OM - it's good, but by current reading it is not significantly superior to other candidates. Also, probably only Polymedix trials for ABSSSI have a size to satisfy FDA about risk being acceptable. What little I know about accelerated approval is that it still takes evidence from sizeable trial ~ headcount > 100.
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