Vote at odds with FDA reviewers
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.
FDA advisory panel backed Replimune's RP1 melanoma data ahead of the agency's August 2 decision despite earlier staff criticism.
Replimune defends its single-arm RP1 melanoma trial data as an FDA advisory panel prepares to vote on whether results are interpretable and RP1 works.
STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.