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Re: enthalpy post# 7409

Tuesday, 11/24/2020 10:22:16 AM

Tuesday, November 24, 2020 10:22:16 AM

Post# of 8928
This is easy approval for DMD. FDA guidance for AA doesn't actually require clinical benefit but based on surrogate endpoint that an be used to indicate clinical benefit and we are way past that.

https://www.fda.gov/drugs/information-healthcare-professionals-drugs/accelerated-approval-program
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