RE:How does Accelerated Approval work Endpoints reported today that OV company Replimmue "aims" for accelerated approval for their intratumorally delivered OV + nivolumab (Optivo) in the treatment of melanoma after reporting a 28.3% all subgroup overall response rates (ORR) in its RP1 IGNYTE Phase 1 clinical trial in PD-1 failed melanoma patients.
https://endpts.com/replimune-aims-for-accelerated-approval-of-melanoma-therapy-structures-upsized-476m-offering/