Agree that the approval path remains murky, I think that removing the peripheral neuropathy isn't enough, carfilzomib needs to show at least 25% ORR in Velcade refractory patients in order to get accelerated approval with this open label single arm phase IIb trial, so far it's 18%.
Onyx Pharmaceuticals Announces Agreement with the FDA on a Special Protocol Assessment for Planned Phase 3 Carfilzomib Combination Trial in Relapsed Multiple Myeloma
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