Regulatory ChallengesWith functional unblinding a known challenge in the field and expectations high, the quality and robustness of the Phase 3 data will be especially important in determining regulatory path and commercial viability.
Regulatory RisksMM120’s development strategy includes measures intended to mitigate regulatory risks common to psychedelic trials, which may support a potential New Drug Application submission in 2027.
Trial Enrollment RisksThe primary endpoint in both GAD trials is a well-established regulatory benchmark, and the trials are powered at 90% to detect a significant difference versus placebo.