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FDA fires broadside at CytoDyn over COVID-19 antibody data

May 19, 2021


It’s not uncommon for drug developers put a positive spin on lacklustre clinical data, but CytoDyn’s attempts seems to have irritated the US regulator, specifically relating to its use of subgroup analyses to try to indicate a benefit for leronlimab.

The biotech has run two studies to try to repurpose HIV and cancer candidate leronlimab as a COVID-19 therapy, neither of which achieved their primary objectives, but has said it will nevertheless file the data with regulators in countries including India and the Philippines.

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