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The Food and Drug Administration refused to accept an application seeking the approval of a drug to treat HIV from CytoDyn — a setback that could delay a decision for months, if not years.

The so-called Refuse-to-File letter, issued by the FDA against CytoDyn’s drug called leronlimab, is also the most damning evidence yet that CEO Nader Pourhassan and other company executives might be misleading investors.

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