Psychedelic Brief

Ledger

Open
9
Resolved
1
Falsified
0
Void
1
  1. Issue 1125 August 2026open

    Before 31 December 2026 the ClinicalTrials.gov record for NCT07775300 (Lilly, brenipatide, Phase 3 MDD) will show overall status RECRUITING AND still carry at least one of Germany, Greece, Poland, Spain or the United Kingdom in its location list. Our read of whether the EU-member site list is real intent or paperwork.

    Resolves
    31 December 2026
    Criteria
    Falsifier, two conditions, both must hold for a HIT: on 31 December 2026 the record's `overallStatus` is anything other than RECRUITING → miss; OR all five of DE/GR/PL/ES/UK have been dropped from `LocationCountry` → miss.
  2. Issue 1018 August 2026open

    No pharmaceutical company will be named as the responsible party on a BfArM compassionate use entry for psilocybin or MDMA before 31 December 2027. Our read, not anyone's stated plan.

    Resolves
    2027-12-31 (or earlier if an entry appears)
    Criteria
    Falsifier: any company named in the *Verantwortliche Person* column for psilocybin or MDMA before 2027-12-31 → miss.
  3. Issue 94 August 2026open

    Compass Pathways will NOT publicly disclose a marketing authorisation application to the MHRA or the EMA for COMP360 before 30 June 2027 — the end of its own guided US launch window. Our read, not Compass's stated plan; the company has said nothing about future European intent in either direction.

    Resolves
    2027-06-30 (or earlier if disclosed)
    Criteria
    Falsifier: Compass discloses a UK or EU application, or a regulator's register shows one, before 2027-06-30 → miss.
  4. Issue 828 July 2026open

    No psilocybin or MDMA therapy will enter a formal health technology assessment or benefit assessment process in Germany, the Netherlands or the United Kingdom before 31 December 2027. Our read, not anyone's stated plan.

    Resolves
    31 December 2027
    Criteria
    Falsifier: a manufacturer submits a psilocybin or MDMA therapy to the G-BA, Zorginstituut Nederland, or NICE before 2027-12-31 → miss.
  5. Issue 721 July 2026open

    Within 12 months of the Lilly/AtaiBeckley deal closing, neither BPL-003 nor VLS-01 will have a registered Phase 3 trial carrying ANY EU-member-state site, AND Lilly will have disclosed no EMA pathway for either drug. Our read of the deal's incentives, not Lilly's stated plan.

    Resolves
    12 months after acquisition close (close date not yet public; backstop 2027-07-21)
    Criteria
    Falsifier: a registered Phase 3 for either drug with any EU-member-state site, OR a disclosed EMA pathway for either, within the window → miss.
  6. Issue 614 July 2026open

    COMP360 (Compass psilocybin) will NOT be commercially available to prescribe in the US by 30 June 2027 — i.e. the guided "first half of 2027" launch slips.

    Resolves
    2027-06-30 (or earlier if launched)
    Criteria
    Falsifier: if COMP360 is FDA-approved AND commercially available to prescribe in the US on/before 30 June 2027 → miss.
  7. Issue 57 July 2026open

    AtaiBeckley's BPL-003 Phase 3 program, when it registers, will use an ADJUNCTIVE design (patients stay on a stable SSRI, no antidepressant washout mandated). BPL-003 commits to the adjunctive camp, not the washout camp (Compass/EPIsoDE).

    Resolves
    BPL-003 Phase 3 registry posting, expected H2 2026
    Criteria
    Falsifier: if the Phase 3 eligibility on ClinicalTrials.gov requires discontinuing a stable SSRI before dosing → miss.
  8. Issue 430 June 2026open

    Definium's Panorama (Phase 3 GAD, DT120 100µg, with 50µg low-dose unblinding-control arm + EU sites) will show a SMALLER placebo-adjusted effect than its sister trial Voyage (same indication/scale, no low-dose arm). Tests whether the Emerge headline is drug or expectancy.

    Resolves
    Both readouts public; guided 2026, target year-end (stays open if Panorama slips to 2027)
    Criteria
    HIT if Panorama's 100µg-vs-placebo separation is LESS than 5.4 points. MISS if it is 5.
  9. Issue 323 June 2026open

    AtaiBeckley will report first BPL-003 Phase 3 patient dosed in Q3 2026 (after 30 June, before 30 September).

    Resolves
    30 September 2026
    Criteria
    Not stated
  10. Issue 216 June 2026HIT

    AtaiBeckley will NOT announce first BPL-003 Phase 3 patient dosed before 30 June 2026. Expects initiation language near the wire; confirmed dosing slips to Q3.

    Resolves
    30 June 2026
    Criteria
    Not stated
  11. Issue 19 June 2026void

    No call made — "The Call" section not yet established in this issue.

    Resolves
    Not stated
    Criteria
    Not stated