AVXL's glacial pace starting to hurt the business.
Very disappointing! -Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. The FDA has granted a priority review and assigned a PDUFA (Prescription Drug User Fee Act) action date of March 12, 2023
6 months behind at the minimum. Not good.
Still no P3 for PD either. What are all the former FDA bureaucrats doing for their AVXL salaries?
And the rare disease trial is a running joke at this point...mentioning it just highlights the failure to deliver.