A reader should note that the difference does not arise from different patients, but from different rules for deciding what counts as a response. Replimune has said a different FDA review team was assigned to the second resubmission. July 28, 2026: FDA briefing documents released, stating reviewers cannot verify reported efficacy results. June 26, 2026: FDA accepts third submission as a complete class 1 response and sets an August 2 decision date. Why do the company and the FDA report different response rates?