It’s possible, approvals on far less compelling
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Posted On: 10/24/2018 7:43:07 AM
Re: aragon1959 #50272
It’s possible, approvals on far less compelling recent studies. Look at SRPTs DMD approval. The FDA statistician thought they didn’t prove anything on a 12 patients. But no treatment available and patients parents brow beat FDA Director into an approval. I think P doesn’t need a PIII trial either. IMO
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