| Outcome | Probability | Yes Bid | Yes Ask | 24h Change | Volume | |
|---|---|---|---|---|---|---|
| Before July 2027 | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| Before October 2027 | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| Before 2028 | 0% | 0¢ | 0¢ | — | $0 | Trade → |
This market asks when the U.S. Food and Drug Administration will grant marketing approval for Compass Pathways' COMP360 psilocybin therapy, an event that would shape clinical availability and commercial prospects for a novel psychiatric treatment.
COMP360 is a synthetic psilocybin formulation developed by Compass Pathways and has progressed through clinical development for psychiatric indications; FDA approval requires robust evidence of safety, efficacy, and consistent manufacturing. Timing depends on the sponsor's submissions, the results and completeness of pivotal trials, and regulatory review steps that can include advisory committee input and facility inspections.
Market prices aggregate participants' expectations about the timing of FDA approval and update as new data or regulatory actions occur; they should be interpreted as a real‑time consensus view that can shift with trial readouts, filings, or agency communications.
The market is structured as three mutually exclusive timing outcomes that divide possible FDA approval dates into different windows (including the possibility of no approval within the last window); check the market interface for the exact date ranges that define each outcome.
Key milestones include the submission and acceptance of a marketing application, release of pivotal trial topline and detailed results, an FDA advisory committee meeting or briefing materials, issuance of a Complete Response Letter or approval, and outcomes of FDA manufacturing inspections.
An advisory committee can influence timing by providing public expert input that the agency may weigh heavily, potentially accelerating clarity if favorable or prompting additional data requests or conditions that extend review when concerns are raised.
DEA scheduling is a separate legal process; FDA approval focuses on safety and efficacy, but scheduling decisions and any required risk‑management program (e.g., REMS) affect how the product can be used post‑approval and can influence commercial rollout timelines.
Watch for public announcements of pivotal trial readouts, formal submission of a marketing application, FDA meeting requests or communications, regulatory filings or press releases about inspections or manufacturing readiness, and any material adverse safety findings.