Home / Top News / FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12 The CD12 trial completed enrollment with 394 patients on December 16 VANCOUVER, Washington, Dec. 24, 2020 (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 the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.