Cash Flow ConcernsReplimune will likely need to re-run its clinical studies to get to approval and may not have enough cash on its books to get there, in our view.
Clinical Trial ConcernsThe FDA did not view the IGNYTE trial as an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.
Regulatory ChallengesThe FDA issued a Complete Response Letter regarding the Biologics License Application for RP1, which was viewed as a negative surprise.