Replimune has received an early August decision date for its resubmission of RP1, setting up a potential regulatory inflection after two prior FDA rejections for advanced melanoma. The FDA accepted the resubmitted biologics license application, with an expected outcome on or before Aug. 2. The agency has also indicated an advisory committee meeting in late July, consistent with the re-engagement of panels around contested oncology submissions. RP1 is being proposed in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for patients with disease progression after prior PD-1 therapy. The regulatory path is tightly watched: the first rejection cited that the pivotal study did not meet “adequate and well-controlled” criteria, while the second found the data package insufficient to support substantial evidence of effectiveness. The timeline now turns the spotlight to whether revisions can withstand that earlier standard.