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Posted On: 12/09/2021 9:36:11 AM
Post# of 154137
Yes, very significant, particularly the full quote, not merely your snippet:
I would assume they would not quote the FDA unless they had the backup to prove that such statement was actually made, such as it came in the form of a letter back to them. Would be hard for the FDA to bash something that they themselves stated.
Quote:
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.”
I would assume they would not quote the FDA unless they had the backup to prove that such statement was actually made, such as it came in the form of a letter back to them. Would be hard for the FDA to bash something that they themselves stated.
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