CytoDyn and its CEO Nader Pourhassan have known the company’s long-delayed HIV drug was in far more trouble with the Food and Drug Administration than was disclosed to investors, according to new documents filed this week as part of an ongoing civil lawsuit.
The documents reveal that in May 2020, CytoDyn submitted a marketing application for its drug called leronlimab with the FDA, despite knowing the filing was missing crucial information and was largely incomplete.
Two months later, when the FDA declined to review the leronlimab application, CytoDyn executives downplayed the seriousness of the regulatory setback in public statements.
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