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Psilocybin will be the first classic psychedelic to receive FDA NDA acceptance for review for treatment-resistant MDD, with acceptance by Q2 2028

Predicted 2026-04-27 · Resolves 2028-06-30 · regulation · USA
74%
ORACLE CONFIDENCE
⏳ Pending
Every outcome is scored publicly in the ledger.

The EPISODE trial data, combined with Usona Institute's COMP360 Phase 2 results and the accumulating MAPS/Compass Pathways Phase 2b dataset, represents a convergence of Phase 3-quality evidence that no other classic psychedelic can currently match. Critically, psilocybin's safety profile has no cardiac analogue to ibogaine and no scheduling-plus-DEA-complexity analogue to MDMA. The FDA's January 2023 Breakthrough Therapy designation for Compass Pathways' COMP360 and the clean adverse event profile across 12+ trials create a regulatory runway that is unusually unobstructed. The fluoxetine-psychedelic interaction data (see separate prediction) is a solvable problem — washout protocols — not a blocking problem. The 0.74 confidence is calibrated against two real risks: (1) durability data from EPISODE's 12-month follow-up, expected within 18 months, must hold above ~40% sustained response or

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