Pfizer’s Paxlovid does not hold up as well for those vaccinated, new data shows – Endpoints News
In its quest to submit its Alzheimer’s-induced psychosis drug Nuplazid to the FDA for a CRL, Acadia Pharmaceuticals will have to meet with an advisory committee later this week. And agency officials released their briefings ahead of Wednesday’s hearing, revealing a mixed bag of opinions.
FDA statisticians found that the data supporting Acadia’s resubmission, which includes several post-hoc analyzes of the previous pivotal study, did not appear to conclude that the drug is effective in Alzheimer’s patients. But Acadia also repositioned a previous study as the main focus of the application, and regulators seemed open to considering this new approach.
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