The FDA is just being whimsical. Since we are not pursuing HIV or Covid a new protocol or IND is unnecessary for either. In theory the Phase 1 safety data from Progenics and the data from the Phase 2 NASH trial should be sufficient to proceed with a phase 3 NASH trial. Of course the FDA being what it is they would probably withhold approval of a Phase 3 NASH trial without a review of all safety data.

The bureaucrats at the FDA have little understanding of leronlimab. If they took the time to do the research they'd see that leronlimab's anti-inflammatory and anti-cholesterol effects mitigate the chance of a heart attack.