Competitive And Safety PressuresA promising rival candidate with strong efficacy data and potential safety concerns could shift prescriber and payer preferences, intensifying competitive pressure on market share.
Operational ScalabilityExtended single-session monitoring requirements create uncertainty about clinic throughput and staffing scalability, which could hinder broader commercial roll-out.
Trial Integrity RiskPrior patient experience with psychedelic medicines may compromise blinding in PTSD trials, creating risks for trial conduct and the perceived robustness of efficacy results.