Acasti to proceed with phase 3 clinical safety study for gtx-104 following fda feedback, and upon approval of the full study protocol to be submitted to the ind

Company expects the first patient to be enrolled during the second half of 2023 laval, qc , april 4, 2023 /prnewswire/ -- acasti pharma inc. ("acasti" or the "company") (nasdaq: acst), a late-stage, specialty pharma company advancing drug candidates for rare and orphan diseases, today announced that it received a type c written meeting response and clarifying feedback from the united states food and drug administration (fda) on acasti's proposed phase 3 safety study for gtx-104. the fda provided additional comments on the company's development plan that, pending submission of the final clinical protocol and fda approval of same, will allow acasti to proceed with the initiation of a phase 3 safety clinical trial in aneurysmal subarachnoid hemorrhage (asah) patients.
ACST Ratings Summary
ACST Quant Ranking