| Outcome | Probability | Yes Bid | Yes Ask | 24h Change | Volume | |
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| before September | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| before October | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| before November | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| before December | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| before 2027 | 0% | 0¢ | 0¢ | — | $0 | Trade → |
| before April 2027 | 0% | 0¢ | 0¢ | — | $0 | Trade → |
This market asks when Compass Pathways will formally submit a New Drug Application (NDA) to regulators for COMP360, their psilocybin-based therapeutic candidate. The timing matters because an NDA submission is the formal step that begins regulatory review toward possible approval and commercialization.
Compass Pathways is a clinical-stage company developing COMP360 for psychiatric indications; the program advanced from early-stage proof-of-concept trials into larger, later-stage studies and regulatory interactions. An NDA typically follows completion and analysis of pivotal trials, demonstration of manufacturing and product quality (CMC), and preparatory meetings with regulatory agencies.
Market prices reflect aggregated expectations about when those regulatory, clinical, and manufacturing prerequisites will be met and when a formal filing will be sent to regulators. Prices update as new trial readouts, company announcements, or regulatory developments arrive.
A submission generally means the sponsor has formally filed the NDA dossier with the regulatory authority and the agency has recorded receipt. In practice that is the date the agency logs the application as received. Some markets may specify alternative criteria—check the market rules if you need the precise operational definition.
In a rolling NDA the sponsor files modules over time; some observers treat the date of the first electronic receipt as the submission date while others wait for a complete filing or for agency acknowledgement of a rolling submission. How this event treats rolling filings depends on the market's definition, so watch announcements from the market operator.
Sponsors commonly hold pre-NDA (Type B) meetings to align on submission content, review safety database adequacy, and confirm CMC plans. Prior interactions can include end-of-Phase-2 or end-of-Phase-3 meetings and ongoing correspondence about trial design, statistical plans, and manufacturing controls.
Key signals include announcement of completed pivotal trial enrollment or data lock, public top-line or full data readouts from pivotal studies, completion and release of required stability and batch-release CMC data, and formal pre-NDA meeting outcomes indicating a clear path to filing.
Delays can come from unexpected safety findings that require more analysis, requests for additional or longer-term data, CMC problems such as failed stability or batch release tests, data integrity or site inspection issues, or strategic corporate decisions such as seeking extra funding or changing commercialization plans.