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Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups

Executive Summary

Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.

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Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.

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