I think 525 milligrams was in the mono trial. I think in the combo trial they only used 350 milligrams.

700 milligrams was not a request by CyDy. I think the request to include 700 mg in the combo BLA was made by the FDA and CYDY simply said ok because the request did not include a do-over of the combo trial at 700 mg.

The FDA simply said. "If you run safety oin the mono trial at 700 mg, then we could approve combo at 700 without a comb trial do-over".

This is favorable to CYDY as it eliminates the need for human trials at 700 for combo therapy.

However, with the FDA's recent "File Letter", or whatever its called, it seems to me that CYDY has lost patience with the FDA.

CYDY wanted a PDUF in HIV combo, and the FDA's failure to provide it has motivated CYDY to see if they can get a very fast PDUFA in the UK at 350 milligrams.

Then if the UK says, "Sure 350 combo is quickly approvable by us" then the FDA has a bit of egg on their face.

I agree HIV is a done deal. I applaud Pourhassan for attempting to pull in the schedule with a 350 milligram combo BLA in UK.

I know nothing about covid in UK, let alone leron