On Tuesday, psilocybin developer Compass Pathways shared topline data from its Phase 3 program in treatment-resistant depression. We covered that readout extensively:

• BREAKING: Second Positive Phase 3 for Compass’ Psilocybin, Though Modest Magnitude Raises Questions
• Compass Provides Fuller Phase 3 Picture, MADRS Curves, on Webcast

We also reached out to researchers, practitioners, and executives across the psychedelics field to get their perspectives on the data and its potential implications. Below, we summarise their views…

In this Article

• FDA Approval: “When, Not If”?
• -3.8 Delta: “More Approvable than Category-Defining”?
• Incremental Benefit of a Second Dose
• Psychological Support: Safety Baseline or Efficacy Ceiling?
• From Trial Sites to Treatment Networks
• Open Questions and Competitive Ripples

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FDA Approval: “When, Not If”?

A common theme we heard from those we spoke to was the belief that FDA approval for Compass’ program is now a matter of ‘when, not if.’

“I anticipate this will get approved”, Sandeep Nayak, Medical Director of the Johns Hopkins Center for Psychedelic & Consciousness Research, told Psychedelic Alpha. He pointed to various trial design features of the Phase 3 program, including the small proportion of participants with prior psychedelic experience, the generation of durability data, and the collection of ‘adverse events’ related to subjective drug effects. All three of these design features were viewed by FDA as deficient in the ill-fated Lykos Therapeutics (now Resilient Pharmaceuticals) MDMA new drug application (NDA), according to FDA’s complete response letter (CRL). On the safety front, too, he noted that the profile is generally “reassuring”, with no instances of suicidal ideation in the 25 mg arm of COMP006.

Psychedelic researcher Robin Carhart-Harris also believes the results should be sufficient for approval. “The efficacy outcomes were modest”, he told us, “but still the required hit to get Compass past the finishing post.” All-in-all, he added…