CytoDyn Files CMC Of Interim Order Application To Health Canada For COVID-19 - Quick Facts

By RTTNews Staff Writer ✉ | Published: 4/19/2021 6:35 AM ET

CytoDyn Inc. (CYDY.OB), a late-stage biotechnology company developing leronlimab, has submitted the manufacturing section of the application for an Interim Order to Health Canada for COVID-19 under a rolling review. This documents the company's manufacturing practices are in full compliance with GMP requirements.

CytoDyn also noted that, in Brazil, two clinical trial protocols for COVID-19 will be submitted to ANVISA, the Brazilian regulatory authority. In the U.S., the company will soon finalize a COVID-19 trial protocol to potentially include a dosage regimen utilizing IV as the first dose and three subcutaneous doses thereafter.

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