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Compass Pathways Submits FDA New Drug Application For Comp360 Psilocybin For Treatment-Resistant Depression

Benzinga Newsdesk 1 hour ago

FDANews

Robust NDA submission supported by data from two highly statistically significant Phase 3 trials and a Phase 2b study that each met its primary endpoint and involved a total of more than 1,000 participants living with

Robust NDA submission supported by data from two highly statistically significant Phase 3 trials and a Phase 2b study that each met its primary endpoint and involved a total of more than 1,000 participants living with highly chronic TRD
Deep commercial capabilities in place to enable successful launch execution and broad patient access with launch readiness on track for expected launch in H12027, subject to FDA approval

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