False · Brier 0.09
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 10 Sep 2019 · doblin-0095
Quote
“So if somebody wanted to market a generic, they could if they generate their own data. But it’s going to take them more than five years and $35 million or $40 million. So they’ll probably just wait this out.”
Boston Magazine Q&A on the anti-patent strategy and five-year data exclusivity. Doblin predicts generic competitors will not run their own trials during the exclusivity window.
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 ›
- A second sponsor pursues its own MDMA-for-PTSD program with its own clinical data
- 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 ›
- Trial outcomes
- 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 10 Sep 2021
- Probability
- 0.30 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 › B · “probably” · denialA statement that the event will not happen. Its probability on the event side is 1 minus the bin value. Method ›
- 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
- affiliated, denial, 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-0081 · deadline none · bin B
Registry entry
A sponsor other than MAPS Public Benefit Corporation (or its successor) runs its own clinical program for midomafetamine (MDMA) for post-traumatic stress disorder on its own clinical data.
TRUE on the earlier of (a) the ClinicalTrials.gov study start date of the first interventional Phase 3 (or Phase 2/3) trial of midomafetamine (MDMA) for post-traumatic stress disorder whose sponsor is not MAPS Public Benefit Corporation, MAPS, or a successor or licensee of their program, and (b) the date of the definitive public announcement (press release or SEC filing) that such a sponsor has filed its own US marketing application for MDMA for PTSD on its own clinical data. Trials run by MAPS PBC or its successor, trials of MDMA for other indications, Phase 1 or Phase 2 trials, an application that relies on the MAPS program's data, a rumour and a letter of intent do not count. Resolution source: ClinicalTrials.gov, with the sponsor's press release as a secondary source. FALSE at the deadline when no such trial or application is on record.
Resolution source: ClinicalTrials.gov; sponsor press release or SEC filing as a secondary source
Readings: 'generate their own data' = a competitor runs its own pivotal MDMA-for-PTSD trial; 'wait this out' = no such trial is started.; 'Their own data' excludes an application that relies on the MAPS program's clinical data; the sponsor must produce the data itself.
How to read
Coder C
Resolution
- State
- False
- 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 ›
- 10 Sep 2021
- 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 ›
- occurred on 6 Oct 2023 · checked through 14 Sep 2026
- Resolver note
- Criterion (a) is met. The first interventional Phase 3 MDMA-for-PTSD trial with a sponsor outside the MAPS programme is NCT05979844 (Dr. Leslie Morland, VA San Diego), actual start 2023-10-06; it administers MDMA and produces its own data, with Resilient (ex-Lykos) only a collaborator supplying drug. Three later independent records confirm the pattern: NCT06117306 (Healing Breakthrough, 2024-10-25), NCT06394284 (Herzog Hospital, 2024-02-18) and NCT07118839 (VA ORD, Phase 2/3, 2026-05-18). NCT06189027 (USC, start 2018-11-20) is excluded: it is a saliva biomarker add-on to the MAPS trial MAPP1 and gives no drug itself.
- Evidence
- MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD (NCT05979844), Phase 3, sponsor Dr. Leslie Morland, VA San Diego Healthcare System; actual start 2023-10-06 · 7 Aug 2023
- MDMA-assisted Massed Prolonged Exposure for PTSD (NCT06117306), Phase 3, sponsor Healing Breakthrough; actual start 2024-10-25 · 7 Nov 2023
- IISPT2: Examining MDMA Effects in Veterans With PTSD and Moral Injury (NCT06394284), Phase 3, sponsor Herzog Hospital, Israel; actual start 2024-02-18 · 1 May 2024
- MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder (NCT07118839), Phase 2/Phase 3, sponsor VA Office of Research and Development; actual start 2026-05-18 · 14 Sep 2026
- BrierThe squared gap between a probability and the outcome, (p - o)^2. 0 is perfect, 0.25 is the constant coin flip, 1 is confidently wrong. Lower is better. Method ›
- 0.09 = (0.30 − 0)²
- Happened laterFor items scored false whose event later happened: the months between the deadline and the outcome date. Median and quartiles are reported. Method ›
- Yes, 25 months after the deadline
Adversarial recheck
upheld (criterion): Case for an earlier date: ClinicalTrials.gov holds NCT06189027, an interventional Phase 3 study titled 'Epigenetics and MDMA-Assisted Psychotherapy for PTSD', lead sponsor University of Southern California, with MDMA listed as a drug intervention and an actual start of 2018-11-20. Read literally, criterion (a) is met there, five years earlier. The record defeats the reading: the summary says it is 'an add-on substudy to an already-approved clinical trial' NCT03537014, the MAPS trial MAPP1, with MAPS as collaborator. USC collects saliva; the drug arms it lists are the parent trial's. It generates no MDMA-for-PTSD clinical data of its own, which the reading requires. A weaker attack on NCT05979844, that Resilient (ex-Lykos) supplies drug as a collaborator, also fails: the criterion excludes only MAPS, MAPS PBC, a successor or a licensee, and Dr. Leslie Morland is the sponsor. Phase 3, actual start 2023-10-06 confirmed.
How to read
Registry
Timeline
1 claim against 44 events in the field.
Trial outcomes