FDA recommending continue trial to support “traditional approval on gfr” is basically telling dimx to forget accelerated approval on protien-uria , not gonna happen. So in this ANN why they keep banging on about running a 2nd interim analysis for a “potential” accelerated conditional approval when fda has told them it’s not going to happen is just tone deaf imo.
my nephrology mate has been right all along about this
FDA recommending continue trial to support “traditional approval...
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