The FDA had no problems with the safety of leronlimab until a few cases of heart complications in Brazil. Even though Covid itself can cause heart inflammation and even after the DSMC cleared leronlimab as safe to use. It seems like the FDA used it as one more way to punish Cytodyn.

With the number of previous patients and the extensive safety reporting requirements of the FDA any problems would have been flagged much earlier. Remember this is the same FDA that approved Aduhelm a drug that has shown no benefit and causes potentially fatal brain bleed.