Compass Pathways expects earlier FDA approval decision on its psilocybin drug

FAQ: Timeline for FDA ibogaine approval

What is the FDA process? To commercialize a new drug, the Food and Drug Administration requires three ‘phases’ of testing to demonstrate that a molecule is both safe and effective for the treatment of a specified condition. Drug makers (“sponsors”) finance and run trials for which the study design must be pre-approved by the FDA. Upon successful completion of the final phase, the sponsor can submit a New Drug Application to the FDA. If if the F…

Compass Pathways expects earlier FDA approval decision on its psilocybin drug

The company plans a rolling submission of data on the depression therapy after a "positive" meeting with agency.

Compass Pathways Accelerates Psilocybin Launch Timeline by 9-12 Months - Psychedelic Alpha

This morning, Compass Pathways announced that it is preparing to launch its psilocybin therapy (COMP360) for treatment-resistant depression (TRD) at least nine months earlier than previously planned, following a “positive” September meeting with FDA. “We’re excited, we think this is great news”, Compass CEO Kabir Nath told Psychedelic Alpha this morning. “This is a potential acceleration by… Source