Reuters Today eIND Resumes FDA Resumes eIND Appro
Post# of 148288
FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix™ (leronlimab) Following Full Enrollment in CytoDyn’s Phase 3 Trial
BY GlobeNewswire
— 6:00 AM ET 12/22/2020
FDA’s decision will enable CytoDyn ( CYDY ) to respond to ongoing requests for leronlimab until Phase 3 trial data is unblinded
VANCOUVER, Washington, Dec. 22, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. ( 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 a treating physician has received authorization from the U.S. Food and Drug Administration (“FDA”) to administer leronlimab for a COVID-19 patient under emergency IND (eIND).