We have this from the FDA Dec. 9th as a response:
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Posted On: 02/22/2022 1:09:47 PM
We have this from the FDA Dec. 9th as a response:
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.”
Again, has anyone seen a critically ill trial in Brazil, i.e., CD16? I only see moderately ill and I think our forte is critically ill since we would have no competition.
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.”
Again, has anyone seen a critically ill trial in Brazil, i.e., CD16? I only see moderately ill and I think our forte is critically ill since we would have no competition.
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