Veru Inc. announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase 3 clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS. The Phase 3 study may suffice as a single study for NDA submission. FDA agreed to a Phase 3, randomized (1:1), multicenter, placebo-controlled, parallel group design study to evaluate the efficacy and safety of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in hospitalized adult patients with any type of virus inducing ARDS: Novel indication (patient population) for sabizabulin has been expanded to include all hospitalized adult patients with any type of viral induced ARDS Endpoints: Primary efficacy endpoint is all-cause mortality at day 60, Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, and proportion of patients alive without respiratory failure; Given the high mortality rate for viral induced ARDS (27-45%), the expected size of the study is 408 patients; If Phase 3 study were to demonstrate sufficient benefit on all-cause mortality at Day 60, then this study could potentially be sufficient for NDA submission; As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin.