Omisirge Review Chronology: From Pre-IND Meeting To Approval
The Pink Sheet charts the 13-year journey from Gamida Cell's initial meeting with the US FDA to Omisirge's eventual approval ahead of an extended user fee date.
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Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
Pink Sheet infographic breaks down the status of origins of 39 programs being pursued by 26 sponsors.