Replimune receives FDA Complete Response Letter for RP1 BLA in advanced melanoma

Replimune Group, Inc.

FDA issues CRL for RP1 + nivolumab; IGNYTE trial deemed not adequate/well-controlled.
CRL cites heterogeneous patient population and need to address confirmatory trial design.
No safety issues raised; Company requests Type A meeting within 30 days.
CEO surprised as issues not raised during mid- or late-cycle reviews.
Without accelerated approval, RP1 development for advanced melanoma patients not viable.

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