Replimune secured an early August regulatory decision date for its third attempt at RP1, an oncolytic immunotherapy for advanced melanoma that has been rejected twice by the FDA. The FDA accepted the biologics license application resubmission and scheduled an advisory committee meeting for late July, with a verdict expected on or before Aug. 2. RP1’s prior rejections centered on the agency’s view that the pivotal study did not qualify as an “adequate and well-controlled clinical investigation” and that the data package was insufficient to support “substantial evidence of effectiveness.” The latest resubmission follows changes in FDA leadership from the period when the first two rejections were issued. The decision timeline is consequential for investors and competitors because RP1 is being developed for accelerated approval in combination with Bristol Myers Squibb’s Opdivo after progression on prior PD-1 therapy. A favorable outcome could return attention to oncolytic strategies in the melanoma space. Replimune’s regulatory process also remains a proxy for how the FDA evaluates evidence quality in high-scrutiny oncology submissions after public controversy around earlier decisions.