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Alias Born 12/07/2016

Re: None

Wednesday, 07/22/2020 8:25:57 AM

Wednesday, July 22, 2020 8:25:57 AM

Post# of 3196
Great time to accumulate, as we still await FDA approval for Nuplazid for the treatment of dementia-related psychosis.

"On July 20, 2020, ACADIA  announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

The FDA has assigned a standard review with a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021. The FDA has also informed the Company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting."

I remember listening intently to the Advisory Committee meeting for Nuplazid before approval for Parkinson's use. Based on trial data and no plan for meeting, I feel like it has a great chance for approval for dementia use.

I work in long term care with residents with dementia and this new approval would be an immense help for the lives of those residents, family and caregivers.

All IMO.
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