With all due respect i think late 2026 for revenue is extremely unlikely. Meetings with the FDA for trial designs will take time, then you have trial enrolments to complete and then the trial times itself which will be subject to FDA requirements. All these add up. If we are lucky enough to have a positive P3 trial then further time is required to submit the NDA, have the FDA review it and, if successful, then prepare the drug for sale. From experience, Acadia completed enrolment in their P3 retts trials on 05/08/2021, positive results were annouced on 07/12/2021, Acadia submitted the NDA on 12/07/2022 with FDA approval on 13/03/2023. First sale was then around 07/06/2023- so approximatley 2 years from enrolment completion to first sale.
PYC Price at posting:
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