CYDY - CytoDyn initiates rolling submission of leronlimab in COVID-19 to Canada regulator

Under a rolling review, CytoDyn (CYDY) has submitted the manufacturing section ((CMC)) of the application for an Interim Order to Health Canada for leronlimab to be considered as a therapeutic for COVID-19.The application documents the Company’s manufacturing practices are in full compliance with GMP requirements.CYDY anticipates the remaining sections will be submitted in the very near future. "In the U.S., we will soon finalize a COVID-19 trial protocol to potentially include a dosage regimen utilizing IV (intravenous) as the first dose and three subcutaneous doses thereafter. We are moving quickly to advance leronlimab along multiple regulatory paths, including securing additional manufacturing from Samsung BioLogics in 2021 and 2022,” commented Nader Pourhassan, Ph.D., President and CEO.

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CytoDyn initiates rolling submission of leronlimab in COVID-19 to Canada regulator