So if it wasn’t part of the combo trial to begin

So if it wasn’t part of the combo trial to begin with is the FDA saying now that it’s required for BLA or not? And if it is then how long will that take? Will the trial have to expand with new patients or can they just use previous information they already have and it’s just a matter of doing the analysis? Can they use the partial information from the mono trial? How does this work? Nader has said BLA will be filed again first half of 2021, right? Is this truly possible given what FDA is wanting?