FDA built advisory committee around Replimune controversies

FDA has assembled an advisory committee with experience in melanoma treatment, biostatistics and trial design, and radiology to consider Replimune's twice-rejected RP1 vusolimogene oderparepvec. The company is seeking to market the therapy as Tudriqev, in combination with BMS’s PD-1 inhibitor Opdivo nivolumab, to treat advanced cutaneous melanoma that has progressed following treatment with a PD-1 inhibitor. 

The disagreements between FDA and Replimune Group Inc. (NASDAQ:REPL) will formally be heard by the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) on July 30, but only two of the 14 voting members are standing members of that committee. The rest were brought in as temporary members, giving the agency a panel built around the specific controversies that led it to issue two complete response letters...