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
Ann: Quarterly Appendix 4C and Activities Report, page-17
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