Forecast Ledgerinterventional psychiatry and psychedelic medicineQuoted, dated predictions scored against public outcomes under one written method. Every score links to the words, the rule and the evidence.

Regulatory decisions

Rules 1.1.0 · as of 14 Sep 2026

109 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 › claims · 23 resolvedA cluster with at least one scored item. Only resolved clusters count toward n. Method › · 94 ground-truth events · Base rates

Approvals, complete response letters, advisory votes, designations, scheduling and rule-making by FDA, DEA, EMA, MHRA, TGA and state regulators for drugs and devices in psychiatry.

Leaderboard

The intervals overlap; no ranking yet.

score95% rangeprovisional (under 30 events)resolved events toward the 5 a score needsreference rowcoin flip 0.25
COIN FLIPANGERMAYER3of 5DOBLINDoblin · 9 of 59of 5MUIRMuir · 0.190.1911 EVENTS00.10.20.30.40.50.6← BETTERBRIER
How to read
Persons are ranked only when both have 5 or more resolvedA cluster with at least one scored item. Only resolved clusters count toward n. Method › events, share a coverage tierHow completely a person's claims were collected: A complete archive, B archive plus search, C search-built. Ranks are shown only inside one tier. Method ›, and their intervalsThe 2.5 and 97.5 percentiles of a statistic over many resamples of the clusters with replacement, drawn with a seeded generator so every run gives the same interval. It shows how much the number could move if the events were redrawn. Method › do not overlap; otherwise rows are alphabetical. The evidence tierHow much resolved evidence a person has: T0 fewer than 10 clusters (counts only), T1 10 to 29 (provisional), T2 30 or more (full). Method › sets whether a row shows a score or a count. Comparators are ad hoc collections (tier C): they get a score at the same minimum, but a search-built corpus under-counts claims, so they are never ranked against the full archive. The reference rowsA leaderboard row that is not a person: the base rate or the market, scored with its own probability on the same clusters. Shows what a rule of thumb would have scored. Method › are scored on the same events; the coin flipThe constant 0.25, the Brier score of saying 0.50 on every item. Drawn as a reference line; not a row on the leaderboard. Method › is the score of saying fifty-fifty every time.

Regulatory decisions · 23 events

Status

6 of 53 resolved claims came true.

TRUETRUE6FALSEFALSE47KNOWN TRUEKNOWN TRUE1PENDINGPENDING36VOIDVOID19109ITEMS1 TICK = 1% OF 109

Regulatory decisions · 109 items

Claims and events

40 claims against 60 events in the field.

saiddueevent
5 Jan 2022 · Health Canada: Canada Gazette publishes SOR/2021-271, restoring Special Access Program requests14 Jan 2022 · DEA: DEA proposes placing five tryptamine hallucinogens (4-OH-DiPT, 5-MeO-AMT, 5-MeO-16 Feb 2022 · FDA: FDA alerts health care professionals to potential risks of compounded ketamine n27 Jul 2022 · DEA: DEA withdraws its proposed Schedule I placement of five tryptamines after hearin19 Aug 2022 · Axsome Therapeutics (Auvelity, AXS-05): FDA approves Auvelity (dextromethorphan-bupropion), the first oral NMDA receptor29 Aug 2022 · DEA: DEA withdraws its April 2022 proposal to place DOI and DOC in Schedule I, citing6 Sep 2022 · Magnus Medical (SAINT): FDA grants 510(k) clearance to Magnus Medical's SAINT Neuromodulation System (MR8 Nov 2022 · Colorado voters: Colorado voters approve Proposition 122 (Natural Medicine Health Act), decrimina27 Dec 2022 · Oregon Health Authority: OHA adopts final administrative rules implementing Measure 109 psilocybin servic2 Jan 2023 · Oregon Psilocybin Services: Oregon Psilocybin Services begins accepting applications for manufacturer, servi3 Feb 2023 · TGA (Australia): TGA announces final decision to reschedule psilocybin (TRD) and MDMA (PTSD) to S1 Mar 2023 · DEA: DEA publishes proposed rules on telemedicine prescribing of controlled substance5 May 2023 · Oregon Psilocybin Services: Oregon issues its first psilocybin service center license (EPIC Healing Eugene);10 May 2023 · DEA and HHS: First temporary extension of COVID-19 telemedicine flexibilities for controlled 23 May 2023 · Colorado Governor Polis: Governor signs SB23-290 (Natural Medicine Regulation and Legalization), creating26 Jun 2023 · FDA: FDA issues draft guidance 'Psychedelic Drugs: Considerations for Clinical Invest1 Jul 2023 · TGA (Australia): Rescheduling takes effect: authorised psychiatrists may prescribe MDMA for PTSD 4 Aug 2023 · Sage Therapeutics / Biogen (zuranolone): FDA approves Zurzuvae (zuranolone) as the first oral treatment for postpartum de29 Aug 2023 · HHS: HHS recommends to DEA that marijuana be moved from Schedule I to Schedule III of7 Oct 2023 · California Governor Newsom: Newsom vetoes SB 58, which would have decriminalized psilocybin and other plant 10 Oct 2023 · DEA and HHS: Second temporary extension of telemedicine flexibilities for controlled medicati10 Oct 2023 · FDA: FDA warns patients and providers about risks of compounded ketamine products, in18 Oct 2023 · FDA / Janssen: FDA approves Spravato labeling supplement S-012 (package insert update).13 Dec 2023 · DEA: DEA again proposes placing DOI and DOC (phenethylamine research hallucinogens) iDEA: DEA AGAIN PROPOSES PLACING DOI AND DOC (PHENETHYLAMINE RESEARCH HALLUCINOGENS) I13 Feb 2024 · FDA / Lykos Therapeutics: FDA accepts Lykos's NDA for midomafetamine (MDMA)-assisted therapy for PTSD with7 Mar 2024 · FDA / MindMed: FDA grants Breakthrough Therapy designation to MM120 (LSD D-tartrate) for genera13 Mar 2024 · Cybin (CYB003): FDA grants Breakthrough Therapy Designation to CYB003 for adjunctive treatment o13 Mar 2024 · FDA / Cybin: FDA grants Breakthrough Therapy designation to CYB003 (deuterated psilocybin ana21 Mar 2024 · Utah Legislature: SB 266 becomes law without the governor's signature, allowing large Utah health 26 Mar 2024 · Neuronetics (NeuroStar): FDA clears NeuroStar TMS as a first-line adjunct for MDD in adolescents aged 15 16 Apr 2024 · European Medicines Agency: EMA holds a multi-stakeholder workshop 'Psychedelics: towards an EU regulatory f21 May 2024 · DOJ / DEA: DOJ publishes proposed rule to transfer marijuana from Schedule I to Schedule II4 Jun 2024 · FDA PDAC / Lykos Therapeutics (midomafetamine): FDA Psychopharmacologic Drugs Advisory Committee votes against MDMA-assisted the4 Jun 2024 · FDA Psychopharmacologic Drugs Advisory Committee: Advisory committee votes 2-9 that MDMA-assisted therapy is not shown effective f7 Jun 2024 · DEA: DEA stays the June 10, 2024 administrative hearing on Schedule I placement of DO9 Aug 2024 · FDA / Lykos Therapeutics: FDA issues a complete response letter (dated August 8) for MDMA capsules for PTS9 Aug 2024 · Lykos Therapeutics (midomafetamine): FDA issues a Complete Response Letter for MDMA-assisted therapy in PTSD and asks29 Aug 2024 · DEA: DEA publishes notice of an administrative hearing on the proposed marijuana resc26 Sep 2024 · Bristol Myers Squibb (Cobenfy / KarXT): FDA approves Cobenfy (xanomeline-trospium), the first muscarinic agonist for sch4 Nov 2024 · FDA / Janssen: FDA approves Spravato labeling supplement S-015 (package insert revision).5 Nov 2024 · Massachusetts voters: Massachusetts Question 4, a regulated natural psychedelics measure, fails with 419 Nov 2024 · DEA and HHS: Third temporary extension of telemedicine flexibilities for controlled medicatio31 Dec 2024 · Colorado Natural Medicine Division: Colorado begins accepting natural medicine business license applications; the re31 Dec 2024 · FDA / Janssen: FDA approves Spravato REMS modification S-013.13 Jan 2025 · DEA Administrative Law Judge: DEA's chief ALJ cancels the January 21, 2025 marijuana rescheduling hearing pend17 Jan 2025 · DEA: DEA publishes proposed rule creating special registrations for telemedicine pres17 Jan 2025 · DEA and HHS: Final rules allow a six-month buprenorphine supply via audio-only telemedicine a21 Jan 2025 · FDA / Johnson & Johnson: FDA approves Spravato (esketamine) as monotherapy for adults with treatment-resi21 Jan 2025 · Johnson & Johnson (Spravato): FDA approves Spravato as the first monotherapy for treatment-resistant depressio24 Mar 2025 · DEA and HHS: DEA and HHS delay the effective date of the buprenorphine and VA telemedicine fi24 Mar 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-018; the REMS still requires certified31 Mar 2025 · Colorado Natural Medicine Division: Colorado issues its first healing center license to The Center Origin (announced7 Apr 2025 · New Mexico Governor Lujan Grisham: Governor signs SB 219, the Medical Psilocybin Act (effective June 20, 2025): DOH15 May 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-021: minor revision to the Patient Mon16 May 2025 · FDA Commissioner Marty Makary: Makary tells NewsNation the FDA will give psychedelic trial data 'an expeditious24 Jun 2025 · HHS Secretary Robert F. Kennedy Jr.: At a House Energy and Commerce hearing, Kennedy says HHS is 'working very hard' 10 Jul 2025 · Czech Senate: Czech Senate gives final approval to a law allowing medical use of psilocybin fr11 Jul 2025 · BfArM (Germany): BfArM approves the EU's first compassionate use programme for psilocybin in trea18 Jul 2025 · Otsuka / Lundbeck (Rexulti, PTSD): FDA advisory committee votes against brexpiprazole plus sertraline for PTSD, cit31 Jul 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-024.FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 4 Apr 2016FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 4 Apr 2016 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 4 Apr 2018FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 7 Apr 2016FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 7 Apr 2016 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 15 Aug 2016 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 19 Apr 2017 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 5 Sep 2017 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 18 Aug 2018 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 18 Nov 2018 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 1 Apr 2019 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 1 Apr 2019 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 18 Apr 2019 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 12 Jun 2019 · p 50%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 31 Dec 2021DEA REGISTERS PRO…DEA registers Prof. Lyle Craker to manufacture cannabis for research · stated 15 Aug 2016DEA registers Prof. Lyle Craker to manufacture cannabis for research · restated 15 Aug 2016 · p 70%DEA registers Prof. Lyle Craker to manufacture cannabis for research · miss 20 Jan 2017FIRST FDA APPROVA…First FDA approval of a psychedelic medicine (class) · stated 5 Apr 2017First FDA approval of a psychedelic medicine (class) · restated 5 Apr 2017 · p 90%First FDA approval of a psychedelic medicine (class) · void 5 Apr 2019FDA CHALLENGES TH…FDA challenges the midomafetamine (MDMA-assisted therapy) Phase 3 results over an unsuccessful double-blind · stated 5 Sep 2017FDA challenges the midomafetamine (MDMA-assisted therapy) Phase 3 results over an unsuccessful double-blind · restated 5 Sep 2017 · p 50%FDA challenges the midomafetamine (MDMA-assisted therapy) Phase 3 results over an unsuccessful double-blind · miss 5 Sep 2019FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · stated 6 Dec 2017FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · restated 6 Dec 2017 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · void 6 Dec 2019FDA LABELING OR R…FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · stated 5 Jan 2018FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · restated 5 Jan 2018 · p 90%FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void 5 Jan 2020FDA LABELING OR R…FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · stated 1 Apr 2019FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · restated 1 Apr 2019 · p 90%FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void 1 Apr 2021FDA LABELING OR R…FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · stated 10 May 2019FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · restated 10 May 2019 · p 90%FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · void 10 May 2021FDA LABELING OR R…FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · stated 10 Sep 2019FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · restated 10 Sep 2019 · p 90%FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void 10 Sep 2021FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 2 Dec 2019FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 2 Dec 2019 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 2 Dec 2021FDA ACCEPTS MAPS'…FDA accepts MAPS' three MDMA program proposals · stated 2 Dec 2019FDA accepts MAPS' three MDMA program proposals · restated 2 Dec 2019 · p 70%FDA accepts MAPS' three MDMA program proposals · miss 2 Dec 2021FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 1 May 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 1 May 2020 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 22 Jul 2020 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 31 Dec 2022FDA APPROVAL OF A…FDA approval of a psilocybin drug product · stated 1 May 2020FDA approval of a psilocybin drug product · restated 1 May 2020 · p 70%FDA approval of a psilocybin drug product · miss 1 May 2022FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 11 Jun 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 11 Jun 2020 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 11 Jun 2022FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 20 Aug 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 20 Aug 2020 · p 50%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 20 Aug 2022FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · stated 26 Aug 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · restated 26 Aug 2020 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · void 26 Aug 2022FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 23 Oct 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 23 Oct 2020 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 6 Nov 2020 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 4 Jun 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 4 Jun 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 21 Jul 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 21 Jul 2021 · p 80%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 25 Aug 2021 · p 50%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 27 Oct 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 2 Dec 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 31 Dec 2023FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 13 Dec 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 13 Dec 2020 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 13 Dec 2022FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 13 Dec 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 13 Dec 2020 · p 50%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 30 Jun 2023DEA REGISTERS PRO…DEA registers Prof. Lyle Craker to manufacture cannabis for research · stated 15 Mar 2021DEA registers Prof. Lyle Craker to manufacture cannabis for research · restated 15 Mar 2021 · p 90%DEA registers Prof. Lyle Craker to manufacture cannabis for research · miss 15 Mar 2023DEA GRANTS THE SC…DEA grants the Schedule I registration for the Bronx VA MDMA-assisted therapy PTSD study · stated 15 Mar 2021DEA grants the Schedule I registration for the Bronx VA MDMA-assisted therapy PTSD study · restated 15 Mar 2021 · p 70%DEA grants the Schedule I registration for the Bronx VA MDMA-assisted therapy PTSD study · hit 17 Nov 2021FDA LABELING OR R…FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · stated 19 Mar 2021FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · restated 19 Mar 2021 · p 90%FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void 19 Mar 2023FIRST FDA APPROVA…First FDA approval of a psychedelic medicine (class) · stated 10 May 2021First FDA approval of a psychedelic medicine (class) · restated 10 May 2021 · p 90%FDA APPROVAL OF A…FDA approval of a psilocybin drug product · stated 4 Jun 2021FDA approval of a psilocybin drug product · restated 4 Jun 2021 · p 70%FDA approval of a psilocybin drug product · miss 31 Dec 2025TEXAS RESCHEDULES…Texas reschedules MDMA out of Schedule I after FDA approval · stated 4 Jun 2021Texas reschedules MDMA out of Schedule I after FDA approval · restated 4 Jun 2021 · p 70%Texas reschedules MDMA out of Schedule I after FDA approval · void 4 Jun 2023EU APPROVAL OF MI…EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 25 Aug 2021EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 25 Aug 2021 · p 50%EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 31 Dec 2024FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 27 Oct 2021FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 27 Oct 2021 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 31 Oct 2023FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 5 Jan 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 5 Jan 2022 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 30 Sep 2023FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 5 Jan 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 5 Jan 2022 · p 90%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 5 Jan 2024FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 29 Jun 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 29 Jun 2022 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 29 Jun 2024EU APPROVAL OF MI…EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 29 Jun 2022EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 29 Jun 2022 · p 70%EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · void 29 Jun 2024CEREBRAL: GOVERNM…Cerebral: government enforcement outcome over its prescribing practices · stated 6 Jul 2022Cerebral: government enforcement outcome over its prescribing practices · restated 6 Jul 2022 · p 50%Cerebral: government enforcement outcome over its prescribing practices · hit 28 Dec 2023DEA PER-STATE PHY…DEA per-state physical-location registration requirement for controlled-substance prescribing is rescinded · stated 9 Aug 2022DEA per-state physical-location registration requirement for controlled-substance prescribing is rescinded · restated 9 Aug 2022 · p 10%DEA per-state physical-location registration requirement for controlled-substance prescribing is rescinded · miss 9 Aug 2024FDA APPROVAL OF M…FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 1 Nov 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 1 Nov 2022 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 19 Feb 2024 · p 70%FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · miss 30 Jun 2024FDA APPROVAL OF C…FDA approval of COMP360 (psilocybin) for major depressive disorder · stated 16 Nov 2022FDA approval of COMP360 (psilocybin) for major depressive disorder · restated 16 Nov 2022 · p 90%FDA approval of COMP360 (psilocybin) for major depressive disorder · miss 16 Nov 2024FDA APPROVAL OF C…FDA approval of COMP360 (psilocybin) for major depressive disorder · stated 16 Nov 2022FDA approval of COMP360 (psilocybin) for major depressive disorder · restated 16 Nov 2022 · p 90%FDA approval of COMP360 (psilocybin) for major depressive disorder · miss 16 Nov 2025EU APPROVAL OF MI…EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · stated 12 Dec 2022EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · restated 12 Dec 2022 · p 70%EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · void 12 Dec 2024FDA LABELING OR R…FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · stated 12 Dec 2022FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · restated 12 Dec 2022 · p 90%FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · void 12 Dec 2024DEA PLACES MIDOMA…DEA places midomafetamine (MDMA) in Schedule III or Schedule IV · stated 12 Dec 2022DEA places midomafetamine (MDMA) in Schedule III or Schedule IV · restated 12 Dec 2022 · p 70%DEA places midomafetamine (MDMA) in Schedule III or Schedule IV · void 12 Dec 2024TODAY20172019202120232025202720292031

Headline panel · Regulatory decisions

Claims

109 claims since 2016; 53 resolved, 37 pending.

truefalsependingvoid
2017201820192020202120222023202420252026202720282029203020314 APR 2016FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 90%AFF7 APR 2016FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 61%AFF15 AUG 2016DEA registers Prof. Lyle Craker to manufacture cannabis for research · false · p 70%AFF5 APR 2017First FDA approval of a psychedelic medicine (class) · void · p 90%AFF5 SEP 2017FDA challenges the midomafetamine (MDMA-assisted therapy) Phase 3 results over an unsuccessful double-blind · false · p 50%AFF6 DEC 2017FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · void · p 90%AFF5 JAN 2018FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void · p 90%AFF1 APR 2019FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void · p 90%AFF10 MAY 2019FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · void · p 90%AFF10 SEP 2019FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void · p 90%AFF2 DEC 2019FDA accepts MAPS' three MDMA program proposals · false · p 70%AFF2 DEC 2019FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 90%AFF1 MAY 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF1 MAY 2020FDA approval of a psilocybin drug product · false · p 70%11 JUN 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 90%AFF20 AUG 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%AFF26 AUG 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS · void · p 90%AFF23 OCT 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 69%AFF13 DEC 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%AFF13 DEC 2020FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF15 MAR 2021DEA grants the Schedule I registration for the Bronx VA MDMA-assisted therapy PTSD study · true · p 70%AFF15 MAR 2021DEA registers Prof. Lyle Craker to manufacture cannabis for research · false · p 90%19 MAR 2021FDA labeling or REMS restricts midomafetamine (MDMA-assisted therapy) to sponsor-trained therapists · void · p 90%AFF10 MAY 2021First FDA approval of a psychedelic medicine (class) · pending · p 90%AFF4 JUN 2021FDA approval of a psilocybin drug product · false · p 70%4 JUN 2021Texas reschedules MDMA out of Schedule I after FDA approval · void · p 70%AFF25 AUG 2021EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%AFF27 OCT 2021FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF5 JAN 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF5 JAN 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 90%AFF29 JUN 2022EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · void · p 70%AFF29 JUN 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF6 JUL 2022Cerebral: government enforcement outcome over its prescribing practices · true · p 50%9 AUG 2022DEA per-state physical-location registration requirement for controlled-substance prescribing is rescinded · false · p 10%1 NOV 2022FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF16 NOV 2022FDA approval of COMP360 (psilocybin) for major depressive disorder · false · p 90%AFF16 NOV 2022FDA approval of COMP360 (psilocybin) for major depressive disorder · false · p 90%AFF12 DEC 2022EU approval of midomafetamine (MDMA-assisted therapy) for PTSD · void · p 70%AFF12 DEC 2022DEA places midomafetamine (MDMA) in Schedule III or Schedule IV · void · p 70%AFF12 DEC 2022FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · void · p 90%AFF5 JAN 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%AFF23 JAN 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 63%AFF25 JAN 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF22 MAR 2023DEA February 2023 proposed telemedicine controlled-substance rule is revised, withdrawn or replaced · true · p 50%31 MAR 2023FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · void · p 90%AFF4 APR 2023FDA approval of COMP360 (psilocybin) for major depressive disorder · false · p 70%AFF1 MAY 2023DEA extends the COVID-era telemedicine flexibilities for controlled-substance prescribing past the PHE end · true · p 87%1 MAY 2023DEA extends the COVID-era telemedicine flexibilities for controlled-substance prescribing a second time · true · p 70%1 JUN 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%1 JUN 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 90%1 JUN 2023FDA labeling or REMS requires supervised in-clinic administration of midomafetamine, with no take-home dispensing · false · p 90%AFF7 AUG 2023First FDA approval of a psychedelic medicine (class) · false · p 90%AFF14 SEP 2023FDA action (approval or complete response letter) on the midomafetamine NDA for PTSD · true · p 70%AFF29 SEP 2023FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF4 JAN 2024FDA authorizes a TMS device for a new indication · false · p 90%19 FEB 2024Israel Ministry of Health approval of midomafetamine (MDMA-assisted therapy) for PTSD · void · p 90%AFF15 APR 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%15 APR 2024A major regulator approves an atai psychedelic therapeutic · pending · p 90%AFF15 APR 2024A major regulator approves an atai psychedelic therapeutic · pending · p 80%AFF8 MAY 2024A major regulator approves an atai psychedelic therapeutic · void · p 90%AFF1 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF5 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · void · p 70%7 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%10 JUN 2024First FDA approval of a psychedelic medicine (class) · false · p 50%10 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 10%14 JUN 2024REMS requirement on FDA-approved psychedelic medicines · void · p 90%15 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 30%16 JUN 2024DOJ charges a second telehealth company over controlled-substance prescribing · false · p 50%21 JUN 2024FDA approval of prazosin for PTSD or PTSD-associated nightmares · false · p 10%26 JUN 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%10 AUG 2024FDA grants the Lykos appeal of the 2024 midomafetamine complete response letter · false · p 10%11 AUG 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 10%16 AUG 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 70%AFF20 SEP 2024Psilocybin, LSD or MDMA drug product approved with retail-pharmacy dispensing · pending · p 20%13 NOV 2024FDA approval of xanomeline-trospium (Cobenfy) for bipolar disorder · pending · p 90%27 DEC 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 70%27 DEC 2024FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 90%AFF20 FEB 2025FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 30%12 MAR 2025FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · false · p 50%AFF9 MAY 2025FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · void · p 50%AFF9 MAY 2025FDA agrees the midomafetamine NDA can proceed without an additional Phase 3 trial · pending · p 50%AFF9 MAY 2025FDA approves a psychedelic drug product with labeling for group-format dosing · pending · p 30%AFF9 MAY 2025FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 90%AFF20 JUL 2025FDA approval of brexpiprazole plus sertraline for PTSD · pending · p 30%21 JUL 2025FDA approval of brexpiprazole plus sertraline for PTSD · pending · p 30%27 JUL 2025First FDA approval of a psychedelic medicine (class) · pending · p 90%28 JUL 2025FDA approval of COMP360 (psilocybin) for major depressive disorder · pending · p 90%AFF28 JUL 2025FDA approves BPL-003 (5-MeO-DMT) on the basis of one Phase 3 trial · pending · p 50%AFF5 SEP 2025FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 10%24 OCT 2025FDA approval of COMP360 (psilocybin) for major depressive disorder · pending · p 90%AFF18 DEC 2025Done Global second federal indictment: conviction · pending · p 70%1 JAN 2026FDA approval of COMP360 (psilocybin) for major depressive disorder · pending · p 90%7 JAN 2026FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD · pending · p 90%AFF4 FEB 2026FDA action (approval or complete response letter) on the COMP360 NDA for treatment-resistant depression · pending · p 70%AFF23 MAR 2026FDA authorizes a TMS device for psychosis · pending · p 90%23 MAR 2026FDA authorizes a TMS device for a new indication · pending · p 90%21 APR 2026Ukraine approves an MDMA or psilocybin drug product · pending · p 90%AFF7 MAY 2026FDA approval of BPL-003 (5-MeO-DMT) · pending · p 90%AFF7 MAY 2026FDA approval of COMP360 (psilocybin) for major depressive disorder · pending · p 70%AFF10 MAY 2026FDA or DEA opens a legal pathway to ibogaine treatment in the United States · pending · p 50%11 MAY 2026FDA authorizes a TMS device for ADHD · pending · p 90%2 JUL 2026First FDA approval of a psychedelic medicine (class) · pending · p 90%10 AUG 2026FDA action on the resubmitted midomafetamine NDA for PTSD · pending · p 90%AFF16 AUG 2026Psilocybin, LSD or MDMA drug product approved with retail-pharmacy dispensing · pending · p 10%19 AUG 2026REMS requirement on FDA-approved psychedelic medicines · pending · p 90%19 AUG 2026FDA approves a psychedelic drug product with no required post-dose monitoring · pending · p 10%19 AUG 2026Psilocybin, LSD or MDMA drug product approved with retail-pharmacy dispensing · pending · p 10%25 AUG 2026First FDA approval of a psychedelic medicine (class) · pending · p 90%27 AUG 2026Psilocybin, LSD or MDMA drug product approved with retail-pharmacy dispensing · pending · p 10%TODAYDOT AREA = P · HAIRLINE = SAID TO DUE

Regulatory decisions · all admitted items