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FDA will formally request endpoint renegotiation or place a clinical hold on at least one active psilocybin or ibogaine addiction trial citing mismatch between extinction-enhancement mechanism and relapse-prevention primary endpoint by Q2 2027.

Predicted 2026-05-01 · Resolves 2027-06-30 · research · USA
38%
ORACLE CONFIDENCE
⏳ Pending
Every outcome is scored publicly in the ledger.

The FDA (US drug regulator) might put a clinical hold on or ask researchers to redesign at least one big psilocybin or ibogaine addiction trial because the main goal (stopping relapse) doesn't match how the drug actually works (helping people forget trauma). This matters because if the FDA thinks a trial is measuring the wrong thing, it can freeze the study until researchers fix it.

If the psilocybin-ibogaine extinction-without-relapse-prevention finding is robust and published in a high-impact venue, FDA's Division of Psychiatry has grounds to question endpoint validity. However, FDA clinical holds and formal endpoint renegotiations are rare and require substantial evidentiary threshold. The specific mechanism-endpoint mismatch argument requires FDA staff to accept a contested neuroscience interpretation. Confidence is moderate-low. Prediction is falsifiable via FDA correspondence, hold notices, or sponsor disclosures. Original title truncated mid-sentence is now completed and sharpened.

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