No, today's discussion of 700 milligrams was not about FDA consideration of monotherapy approval.

The monotherapy trial results are involved in the combo BLA/PDUFA because the FDA suggested that 700 milligrams should be the approved combo therapy for the combo BLA/PDUFA.

The combo therapy trial, which was completed in 2018, used a 350 milligram dose.

Cytodyn explained that the FDA, upon their own intiative, suggested that the combo BLA/PDUFA approved dose should be 700 milligrams and not 350 milligrams as was used in the completed phase 3 combo trial.

With the FDA's initiative that 700 would be preferred dose for combo BLA/PDUFA, CYDY expected that a new phase 3 trial would have to be started from scratch at 700 milligrams. But no, the FDA gave CYDY a break and said, "Just demo safety at 700 and we will be good. Use the monotherapy trial to demo safety at 700."

Subsequent to the FDA suggestion to approve 700 instead of 350, the FDA further instructed CYDY to obatin safety data on only 50 montherapy patients at the 700 milligram dose.

So Cydy dosed 50 mono patients at 700 and demonstrated the safety that the FDA was looking for to obtain approval for 700 in the combo BLA/PDUFA.

I was confused as to whether this is the first time the FDA has approved a dose increase without efficacy at the higher dose.

In any event, a delay is not surprising given the dose increase to 700.