FDA will take a formal action (advisory committee meeting, PDUFA action, or Complete Response Letter) on a psilocybin-for-MDD NDA by 2027-07-01.

Predicted 2026-07-03 · Resolves 2027-07-01 · regulatory · USA

55%

ORACLE CONFIDENCE

⏳ Pending

Every outcome is scored publicly in the ledger.

Compass Pathways is running a large late-stage trial testing psilocybin as a treatment for major depression. If the results look good, they'll submit a formal drug application to the FDA. The FDA would then have to respond — either by approving it, rejecting it, or calling an expert panel meeting to debate it. That full sequence happening by July 2027 is plausible but not certain.

Resolution rule: YES if, by 2027-07-01, the FDA has publicly (a) scheduled/held a Psychopharmacologic Drugs Advisory Committee meeting on a psilocybin MDD product, OR (b) issued an approval or Complete Response Letter for a psilocybin MDD NDA. Verified via fda.gov advisory committee calendar and the sponsor's IR/press release page on 2027-07-01.

Efficacy signals are strong but methodologically contested (functional unblinding, durability). A formal regulatory action — approval, CRL, or AdCom scheduling — is the plausible next milestone given Compass Pathways' Phase 3 program timeline.

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