Pending · due 13 Nov 2026
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 13 Nov 2024 · owen-1309
Quote
“Bristol Meyers Squibb is not done yet. They are going to be bringing this drug to bipolar disorder, and other conditions.”
Same Cobenfy review. The author states that Bristol Myers Squibb will bring Cobenfy (xanomeline-trospium) to bipolar disorder and other conditions.
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 ›
- FDA approval of xanomeline-trospium (Cobenfy) for bipolar disorder
- 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 13 Nov 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 · “They are going to be bringing this drug to bipolar disorder”
- 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
- 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-0034 · deadline none · bin A
Registry entry
The FDA approves xanomeline-trospium (Cobenfy) for a bipolar disorder indication.
TRUE on the date the FDA approval letter or the Drugs@FDA entry (or the sponsor's approval announcement) is dated for an application that adds a bipolar disorder indication to the xanomeline-trospium (Cobenfy) label. Any bipolar I or bipolar II indication counts (for example, acute manic or mixed episodes, depressive episodes, or maintenance), as monotherapy or as an adjunct, and the reading is logged. A complete response letter, a positive advisory vote, a filing acceptance, a trial start or a trial result is not an approval. Approval by a regulator other than the FDA does not count. FALSE when no such indication appears on the Cobenfy label in Drugs@FDA by the deadline.
Resolution source: Drugs@FDA (xanomeline-trospium / Cobenfy approval letters and labeling); Bristol Myers Squibb press release as a secondary source
Readings: 'They are going to be bringing this drug to bipolar disorder' is read as FDA approval of xanomeline-trospium (Cobenfy) for a bipolar disorder indication: the observable end state of bringing a drug to a condition. A trial start, a trial result or a filing does not resolve the event.; 'bipolar disorder' includes any bipolar I or bipolar II indication, as monotherapy or adjunct; a label narrower than 'bipolar disorder' counts, per the drug_approval template rule.; 'and other conditions' is split off as owen-1309-b and is not written into this event.
How to read
Coder A
Resolution
- 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 ›
- 13 Nov 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 ›
- not occurred · checked through 13 Sep 2026
- Resolver note
- Drugs@FDA for NDA 216158 lists a single action, ORIG-1 approved 2024-09-26 (schizophrenia), and no efficacy supplement. The current DailyMed label (updated 2026-01-16) states Cobenfy is indicated for the treatment of schizophrenia in adults only. BMS's Q1 2026 8-K exhibit reports only schizophrenia data for Cobenfy; the bipolar I mania phase 3 program remains in trials (secondary coverage places the readout in 2027) with no filing or approval. No bipolar I or II indication of any kind (manic, mixed, depressive or maintenance; monotherapy or adjunct) appears on the label, so the criterion is not met as of 2026-09-13.
- Evidence
How to read
Registry
Timeline
1 claim against 53 events in the field.
Regulatory decisions