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Acasti Announces Alignment with FDA on GTX-104 Pivotal Phase 3 Safety Trial Protocol and Confirms Planned Initiation of STRIVE-ON in aSAH Patients in Calendar Q4 2023

Acasti Pharma Inc. has announced its alignment with the U.S. Food and Drug Administration (FDA) on the protocol for its pivotal Phase 3 trial of GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV), in patients hospitalized with aneurysmal subarachnoid hemorrhage (aSAH). The company also confirmed its planned initiation of the STRIVE-ON trial in aSAH patients in calen..

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  • · 2023. 7. 6.
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