Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 14 Jun 2024 · owen-1086
Quote
“We require REMS (Risk Evaluation and Mitigation Strategy) certification on site for Esketamine, and 100% of these medicines will come to market with one of these REMS on the FDA-label.”
The author predicts that every psychedelic medicine that reaches the market will carry an FDA Risk Evaluation and Mitigation Strategy on its label, as esketamine does. He then compares the REMS-as-intellectual-property model to Jazz Pharmaceuticals' Xyrem.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- REMS requirement on FDA-approved psychedelic medicines
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 14 Jun 2026
- Probability
- 0.90 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “100% of these medicines will come to market with one of these REMS on the FDA-label”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- conditional, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0023 · deadline none · bin A
Registry entry
Every psychedelic medicine the FDA approves carries a Risk Evaluation and Mitigation Strategy (REMS) on its label at approval.
Resolved on the FDA REMS database (REMS@FDA) read together with Drugs@FDA. For each drug in the psychedelic class (MDMA or midomafetamine, psilocybin, ibogaine and any other compound its sponsor or the FDA describes as a psychedelic or an entactogen; esketamine and ketamine excluded) that receives FDA approval between the statement date and the item's deadline, check whether a REMS is in force on the approval date. FALSE on the date of the first such approval that has no REMS. TRUE at the deadline if every such approval carried a REMS. If no drug in the class is approved by the deadline, the condition is unmet and the item is void. Resolution source: REMS@FDA, with Drugs@FDA for the approval dates.
Resolution source: FDA REMS database (REMS@FDA), with Drugs@FDA for approval dates
Readings: Psychedelic class: MDMA (midomafetamine), psilocybin, ibogaine, and any other compound its sponsor or the FDA describes as a psychedelic or an entactogen. Esketamine and ketamine are excluded: the author uses esketamine as the comparator, not as a member of the class.; 'Come to market' reads as FDA approval; 'with one of these REMS on the FDA-label' reads as a REMS in force on the approval date.; '100%' is the share of the class, not a probability; the confidence phrase is 'will'.
How to read
Coder A
Resolution
- State
- VoidAn item that cannot be scored: the coders disagreed (AMBIGUOUS), the condition was unmet, or the source never published (UNRESOLVABLE). Counted, never scored. Method ›
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 14 Jun 2026
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- unresolvable · checked through 13 Sep 2026
- Resolver note
- The criterion can only be applied once the FDA approves a psychedelic-class drug. As of 2026-09-13 none is approved: Drugs@FDA (openFDA) has no entry for psilocybin, psilocin, midomafetamine/MDMA, lysergide, ibogaine, mebufotenin or DMT; FDA Novel Drug Approvals 2026 lists 39 approvals through 2026-09-11, none in the class; REMS@FDA lists no psychedelic REMS. Nearest candidates: COMP360 psilocybin NDA in rolling submission, all modules due Q4 2026, launch expected H1 2027 subject to approval (Compass, 2026-08-05); midomafetamine NDA resubmitted August 2026, decision pending (MAPS, 2026-08-10); DT120 lysergide has Phase 3 results but no NDA. The criterion says that with no class approval the condition is unmet and the item is void, so neither TRUE nor FALSE applies: unresolvable as of 2026-09-13. Re-check REMS@FDA on the approval date if a class approval arrives before the deadline.
- Evidence
- Novel Drug Approvals for 2026 (39 approvals through 2026-09-11; no psychedelic-class drug)
- Approved Risk Evaluation and Mitigation Strategies (REMS)
- openFDA Drugs@FDA query: psilocybin (no matches)
- openFDA Drugs@FDA query: midomafetamine (no matches)
- Compass Pathways Announces Second Quarter and First Half 2026 Financial Results and Business Highlights (Form 8-K exhibit) · 5 Aug 2026
- MAPS Responds to Report of Progress for MDMA-assisted therapy for PTSD with FDA · 10 Aug 2026
How to read
Registry
Receding horizon
Muir promised REMS requirement on FDA-approved psychedelic medicines 2 times; it has not happened.
Cluster E-0023
Timeline
1 claim against 59 events in the field.
Regulatory decisions