FDA rejects CytoDyn's leronlimab application for HIV

• The FDA has issued a Refusal to File letter to CytoDyn (OTCQB:CYDY) related to its marketing application seeking approval of the combination of leronlimab and HAART (highly active antiretroviral therapy) for highly treatment-experienced HIV patients.
• A Refusal to File letter means that the application was not complete enough to allow for a substantive review.
• The company plans to request a meeting with the agency to discuss the issue, adding that its request does not specify the need for additional clinical trials, rather additional analyses of completed studies, a requirement it says it can provide "as soon as possible."
• On another note, it plans to lock and unblind the data this week from its Phase 2 clinical trial evaluating leronlimab in COVID-19.
• A periodic safety review of data from the Phase 3 trial assessing leronlimab in severely/critically ill COVID-19 patients by the independent Data Safety Monitoring Committee is planned for next week. Results from both studies will be announced this month.
• Management will host a conference call today at 4:00 pm ET to discuss the above.