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Acadia’s Persistence With Pimavanserin In Parkinson’s Psychosis Pays Off

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

After meeting with FDA, Acadia announces it needs only one pivotal study for pimavanserin. The company has canceled a second study and expects to file at the end of 2014. Faster NDA pathway could mean launch a year earlier than expected.

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FDA is concerned the change shown by Acadia's proposed Parkinson's psychosis product may not be clinically meaningful.

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