vida: extract claims from 2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360

- Source: inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md
- Domain: health
- Claims: 0, Entities: 1
- Enrichments: 2
- Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5)

Pentagon-Agent: Vida <PIPELINE>

domains/health/psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability.md

@@ -32,3 +32,10 @@ Oregon's real-world implementation shows facilitators specializing in trauma (83
 **Source:** Bendable Therapy Oregon Measure 109 study, March 2024-April 2025
 
 Oregon real-world naturalistic study shows large effect sizes at 30-day follow-up (PHQ-8: -4.63 points, d=0.90; GAD-7: -4.85 points, d=1.04; WHO-5: +10.67 points, d=2.14) with average dose 27.8mg TPE. However, follow-up limited to 30 days, preventing durability comparison with Compass Phase 3's 26-week endpoint. Study population differs from treatment-resistant depression trials: only 51.1% had depression diagnosis, 64.8% had prior psilocybin experience, and clients were self-selected paying customers rather than trial participants.
+
+
+## Extending Evidence
+
+**Source:** Compass Pathways press release, April 24, 2026
+
+COMP360 completed two consecutive positive Phase 3 trials (COMP005 n=258, COMP006 n=568), becoming the first psychedelic to achieve this milestone. COMP006 showed 39% response rate vs 23% control with rapid onset from next day, and 40%+ of non-remitters achieved remission after second dose. FDA granted rolling NDA review and Commissioner's National Priority Voucher, compressing review timeline to 1-2 months (vs standard 6-12 months). Rolling NDA completion expected Q4 2026, with potential FDA approval as early as Q4 2026-Q1 2027.

entities/health/comp006-trial.md

@@ -0,0 +1,28 @@
+# COMP006 Trial
+
+**Type:** Phase 3 randomized controlled trial  
+**Sponsor:** Compass Pathways  
+**Intervention:** COMP360 (synthetic psilocybin)  
+**Indication:** Treatment-resistant depression (TRD)  
+**Status:** Completed (results announced February 2026)  
+
+## Design
+- **N = 568** participants
+- **Arms:** 25mg vs 10mg vs 1mg (placebo-like control)
+- **Dosing:** 2 doses administered 3 weeks apart
+- **Primary endpoint:** MADRS change from baseline
+
+## Results
+- **Primary endpoint met:** MADRS change -3.8 points vs control (p<0.001)
+- **Response rate:** 39% vs 23% control at week 6
+- **Onset:** Rapid improvement from next day post-dose
+- **Second dose benefit:** 40%+ of non-remitters after first dose achieved remission after second dose
+- **Durability:** Part B 26-week durability data expected early Q3 2026
+
+## Significance
+COMP006 is the second consecutive positive Phase 3 trial for COMP360, making it the first psychedelic compound to achieve two positive Phase 3 results. Combined with COMP005, this formed the basis for FDA rolling NDA review and Commissioner's National Priority Voucher (April 2026).
+
+## Timeline
+- **2026-02** — Results announced
+- **2026-04-24** — FDA granted rolling NDA review based on COMP005 + COMP006 data
+- **2026-Q3** — Part B 26-week durability data expected (final dataset for NDA)

inbox/archive/health/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md

@@ -7,10 +7,13 @@ date: 2026-04-24
 domain: health
 secondary_domains: []
 format: press-release
-status: unprocessed
+status: processed
+processed_by: vida
+processed_date: 2026-05-11
 priority: high
 tags: [psilocybin, Compass-Pathways, FDA, NDA, COMP360, TRD, regulatory, psychedelic, approval-timeline]
 intake_tier: research-task
+extraction_model: "anthropic/claude-sonnet-4.5"
 ---
 
 ## Content