COMPASS Pathways or a competitor will likely submit an NDA (formal approval application) to the FDA by November 2027 for psilocybin as a treatment for severe depression that doesn't respond to other drugs. They have completed Phase 3 trials (the final human testing stage) and have publicly said they're preparing the application. This doesn't mean psilocybin will be approved or legal yet—just that the formal FDA review process will begin.
COMPASS has completed Phase 3 trials and has publicly signaled NDA preparation. The 18-month window (to November 2027) is realistic for NDA compilation and submission given existing data packages. However, competitor filings are uncertain, and COMPASS's own timeline has slipped before. The cocaine use disorder data is not directly relevant to an MDD NDA label and should not be treated as pivotal for that filing. Confidence is moderate: the incentive and data exist, but regulatory preparation timelines are frequently underestimated and capital constraints persist.