- In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients.
- The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for EUA submission and marketing application submission.
- FDA agreed that the current safety data available for sabizabulin is sufficient to support the safety portion of a request for EUA submission.
- Related: Veru's Stock Nearly Triples As COVID-19 Drugs Cuts Reduces Deaths By 55% In Hospitalized Patients.
- The agency informed Veru that additional safety data that would be collected during the use of sabizabulin under the EUA, if granted, will be sufficient to support marketing application submission.
- Furthermore, no additional safety clinical studies are required.
- The company plans to submit a request for a EUA application in calendar 2Q 2022.
- The company has initiated discussions with government agencies to discuss government purchases of sabizabulin in the U.S. and other countries.
- Price Action: VERU shares are up 24.3% at $9.68 during the premarket session on the last check Wednesday.
- Photo by Gerd Altman via Pixabay
