By a 10-3 vote, panelists concluded that the efficacy results from Replimune’s key study were “evaluable and clinically meaningful.” Their decision heightens the chance that the FDA will finally approve that treatment, “RP1,” after twice turning it back. that treatment, “RP1,” after twice turning it back. The drug’s future has been closely watched, as Replimune was one of many companies charging the Marty Makary-led FDA with backtracking on previous agreements. Those questions, in turn, rendered the survival data Replimune compiled and that compared “responders” to “non-responders” unreliable, FDA reviewers wrote.