Veru, Inc. (VERU) Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin
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Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
May 4, 2023 8:30 AM EDTReached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60
Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities
Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for efficacy
If confirmatory Phase 3 clinical trial meets statistical... More
