Acadia Pharmaceuticals Inc
(Get Free Alerts for ACAD) has resubmitted its FDA supplemental marketing application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).- This resubmission responds to the FDA's Complete Response Letter (CRL) to the supplemental marketing application initially submitted for a proposed indication for pimavanserin for dementia-related psychosis.
- The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for ADP and is intended to address the issues raised in the FDA's CRL.
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