Cytodyn Inc (CYDY)

[ClosetInvestor]

“— FDA did everything not to approve HIV combo , even that study finished in February of 2018 with 81% efficacy.”

The phase 2b/3 trial from 2018, with 81% efficacy, only had 47 patients complete the 25 week protocol. The results from the PR look great, but the FDA is never going to approve a drug that completed a trial with only 47 patients COMBINED in the control and placebo arm. CYDY would likely have needed a larger phase 3 for 350mg had the higher dose path not been chosen. Additionally, the data from the 47 patients has never been published, which is unusual for a drug so close to approval.