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Posted On: 12/09/2021 9:34:27 AM
Post# of 148878
Just to elaborate a bit on your post: The fact that there is ongoing {cordial} dialogue between the FDA and Cytodyn has to be a positive sign.
"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.”
"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.”
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