Analyst Sentiment And Market RatingAnalyst's Market Perform rating reflects that available information does not clarify the approval outcome, which could limit upside until regulatory clarity is achieved.
Regulatory Politicization And Media ScrutinyPolitical and media pressure on the regulatory agency increases uncertainty around the approval path for RP1, making the outcome harder to predict and the stock more volatile.
Trial Design And Approvability RiskRegulators previously flagged the registrational trial's lack of a control arm and the inability to isolate each component's contribution, leaving material approvability risk despite a resubmission.