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Hi Kjt

Two problems with the above. Firstly, the RBSQ was already agreed by FDA, and met. The idea the FDA is going to change the goalposts after the fact doesn't make any sense.

Changing the goalposts is what Acadia would argue the FDA did in relation to their Nuplazi dementia-related psychosis filing rejection. In its decision, the agency acknowledged that Nuplazid met the primary endpoint of the Harmony study in a broader psychosis population, but it flagged “limitations in the interpretability” of the results, the company said. In that trial, Nuplazid met its primary endpoint of extending time to relapse in patients with dementia-related psychosis. The FDA last year rejected the drug in that use, with reviewers citing concerns over a lack of statistical significance in some patient subgroups of which Acadia were not aware was required.

https://www.fiercepharma.com/pharma/acadias-nuplazid-gets-second-fda-rejection-alzheimers-disease-psychosis-treatment