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FDA Has Allowed Acasti Pharma To Proceed With The Initiation Of GTX-104 Phase 3 Safety Clinical Trial In Aneurysmal Subarachnoid Hemorrhage Patients

Author: Benzinga Newsdesk | April 04, 2023 08:09am

The FDA concurred with the suitability of the 505(b)(2) regulatory pathway with the selected Reference Listed Drug (RLD) Nimotop oral capsules (NDA 018869), and that Acasti's GTX-104-002 PK study may have met the criteria for a scientific bridge.

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