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Addressing FDA Concerns in Oncolytic Virus Trials

The FDA's concerns regarding Replimune's RP1 + nivolumab trial in advanced melanoma highlight the challenges in evaluating oncolytic virus therapies. The inability to isolate RP1's contribution, heterogeneous patient population, and response assessment issues complicate the interpretation of trial results. These issues hinder the determination of the therapy's efficacy and reliability.

Science, Medicine, Oncology