Replimune notes additional FDA response to trial submission

 In its Quarterly Report on Form 10-Q for the quarter ended December 31, 2022, Replimune Group, Inc. ("Replimune" or "we") disclosed that we had recently received a response from the U.S. Food and Drug Administration (the "FDA") following submission in September 2022 of our draft statistical analysis plan (the "SAP") for the CERPASS clinical trial. In its response, the FDA raised a number of points and recommendations requiring further discussion, including relating to the study endpoints. We have since met with the FDA to discuss its response. During the meeting and as a result of our discussion, the FDA agreed that no changes would be made to the clinical trial protocol and that no material changes would be made to the data analysis plan (minor changes to the SAP were agreed unrelated to the dual independent primary endpoints of overall response rate and complete response rate). Assuming positive primary analysis data is generated, including demonstrating overall clinical benefit, we continue to expect to make a Biologics License Application submission for RP1 in early 2024.

https://www.marketscreener.com/quote/stock/REPLIMUNE-GROUP-INC-44995240/news/REPLIMUNE-GROUP-INC-Regulation-FD-Disclosure-Financial-Statements-and-Exhibits-form-8-K-43098312/