# Fact-check: PASSED

Source: https://research.dreamlab.institute/psilocybin/  
Rounds: 2  

Cited sources (claims may quote these as well as the tracker page):

1. [FAQs: Commissioner’s National Priority Voucher Pilot Program | FDA](https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-pilot-program)

## Round 1: 2 issue(s), sent back to the writer

- line 5 "Yeah, but the extra-dose benefit is just company-reported, uncontrolled data. Grain of salt.": The extra-dose benefit is company-reported, uncontrolled data. — not supported by the page (suggested: "Yeah, but the extra-dose benefit is just company-reported, open-label data. Grain of salt.")
- line 6 "So it's the FDA decision and the label's dosing wording that settle it, not this readout.": The FDA decision and the label's dosing wording settle it. — not supported by the page (suggested: "So it's the FDA decision that settles it, not this readout.")

## Final claims

| line | claim | verdict | page quote |
|---|---|---|---|
| 1 | Compass says one more dose extends depression relief to a full year. | supported | shows additional benefit from another COMP360 dose, extending durability out to 1 year |
| 2 | The 52-week data come from Phase 3. | supported | Compass Pathways' 52-week open-label data from Phase 3 COMP005 |
| 2 | A 2027 launch is targeted. | supported | Compass Pathways targets potential COMP360 launch in 2027 as FDA review advances. |
| 2 | Before the 52-week data, the benefit was durable to 6 months. | supported | two doses beat one; durable to 6 months. |
| 3 | The headline effect was 3.8 points on MADRS versus the 1 mg control. | supported | 25 mg vs 1 mg: both met primary endpoint, MADRS -3.8 at week 6 |
| 3 | The effect is modest. | supported | the effect is modest and depends on multiple doses |
| 3 | The 52-week follow-up is open-label. | supported | 52-week open-label data from Phase 3 COMP005 |
| 4 | The Phase 3 trials enrolled over 1,000 patients and two doses beat one. | supported | Two Phase 3 RCTs, >1,000 patients, 25 mg vs 1 mg |
| 4 | A priority voucher cuts FDA review to 1-2 months. | supported | review drops to 1-2 months after filing. |
| 5 | The extra-dose benefit is company-reported, open-label data. | supported | 52-week open-label data from Phase 3 COMP005 shows additional benefit from another COMP360 dose, extending durability out to 1 year. (vendor-claim) |
| 6 | Whether psilocybin is approved is settled by the FDA's decision, not by the trial readout. | supported | Decisions regarding drug approval remain within the FDA Centers and follow the usual FDA processes. |