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 EUA
CytoDyn submitted protocol to U.S. FDA for immediate enrollment of 140 critical COVID-19 patients with same sites as CD12 trial a?? enrollment to commence upon FDA commentsVANCOUVER, Washington, March 06, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (a??CytoDyna?? or the a??Company"), a late-stage biotechnology company developing Vyrologixa?? (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 been enrolled, but the results have not yet been communicated to any agency.The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.
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