CytoDyn's Leronlimab Suffers Refuse To File Letter; US FDA Concerned About Dosing, Manufacturing

US FDA declines to review the CCR5 antagonist for use in highly treatment-experienced HIV patients. Safety data from an ongoing study should be sufficient to address the agency’s concerns about the higher 700mg dose, CytoDyn management says, but FDA also has questions about the production of the self-injectable syringes.