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Friday, 05/13/2022 10:52:00 AM

Friday, May 13, 2022 10:52:00 AM

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Phase 3 trial of its sabizabulin treatment for hospitalized COVID-19 patients at high risk for acute respiratory disease syndrome. Veru expects to submit a request for an EUA application in the second quarter of 2022. "The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19," said Chief Executive Mitchell Steiner. "In the Phase 3 COVID-19 clinical study, sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients on current standard of care with no significant safety signals."

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