FDA States that Veru Should Submit Request for Emergency Use Authorization (EUA) Based on Positive Efficacy and Safety Data from the Phase 3 Clinical Study of Sabizabulin in Hospitalized COVID-19 Patients
— FDA Agrees that No Additional Efficacy Studies or Safety Data are Required to Support a Request for EUA
— A Request for EUA is Planned for Submission in Calendar 2Q 2022–
–Company Plans to Meet with U.S. and Ex-U.S. Government Officials to Discuss Advance Purchase Agreements
–The Company has a Planned Investors Conference Call at 8:00 AM ET on May 12, 2022 and will Discuss the Outcome of the FDA Meeting and Next Steps
MIAMI, May 11, 2022 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that in a Pre-EUA meeting held May 10, 2022, FDA has agreed that the efficacy and safety data from the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome are sufficient to support the submission of a request for Emergency Use Authorization (EUA).
Read entire article here: https://www.globenewswire.com/news-release/2022/05/11/2440597/11676/en/FDA-States-that-Veru-Should-Submit-Request-for-Emergency-Use-Authorization-EUA-Based-on-Positive-Efficacy-and-Safety-Data-from-the-Phase-3-Clinical-Study-of-Sabizabulin-in-Hospital.html