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Neurocrine’s Bad Dream Continues: Indiplon Approval Requires 3 More Trials

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

An FDA "approvable" letter for Neurocrine Biosciences' beleaguered insomnia agent indiplon requests an additional safety study comparing the 10 mg dose to a marketed product, the firm reported Dec. 13. The firm was "very surprised" by the letter, which requests three new studies in all, Neurocrine CEO Gary Lyons stated during a same-day conference call

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