Thursday, February 10, 2022 2:07:50 PM
In CytoDyn’s recent discussions with the FDA regarding potential marketing approval of leronlimab for critically ill COVID-19 population, the agency stated: “While there are currently fewer U.S. patients hospitalized for COVID-19 daily in the U.S. compared to when you submitted your initial request for an expanded access protocol in August 2021, the CDC reports that 38,332 patients were hospitalized daily in the U.S. during the week of November 7th-13th, 2021. In this context, conducting a clinical trial in the U.S. that could support marketing approval of leronlimab for the treatment of critically ill patients with COVID-19 appears feasible.”
https://www.businesswire.com/news/home/20211209005635/en/CytoDyn-Submits-Protocol-with-the-FDA-for-Phase-3-Registrational-Trial-of-Leronlimab-for-Critically-Ill-COVID-19-Population
Before you go putting your spin, I never said the trial had been approved yet. I said they're letting them move forward which means submitting the protocol.
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