Day: March 7, 2021

CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19

U.S. FDA Reviewing Protocol for More COVID-19 Critical Patients to be Enrolled to Support Potential EUACytoDyn submitted protocol to U.S. FDA for immediate enrollment of 140 critical COVID-19 patients with same sites as CD12 trial – enrollment to commence upon FDA commentsVANCOUVER, Washington, March 06, 2021 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today multiple regulatory pathways for approval of leronlimab as a treatment for critical COVID-19 patients in the U.S., U.K. and Canada.MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have...

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