I tend to agree, I doubt the fda is looking to expand the indication on their own. The problem is that they depend on some level of safety issues and/or non-efficacy. Nothing is 100% and leronlimab is darn near close to that. The fda has to be feeling like something cant be this good and that is why they want as much safety data as possible. They want to make sure they don’t approve a drug this good and find out later there is a problem they missed. Not that there is a problem,btw. The fda is not going to extrapolate data and decide this is approved as a mono treatment without a pivotal mono trail with clean data.

On the other hand, the fda is under pressure to speed up the process and not hold back on revolutionary drugs that can save lives. This might be a win -win -win for the fda, cytodyn and the patients. But, Nader sure is not inferring that discussion is happening and Nader historically can’t hold onto that kind of potential without telling the world. Maybe because it involves the fda and he is being extra careful but I think the fda sees the combo approval as good enough as is for the first of many approvals.

It will be more interesting to see what happens for off-label use after the combo approval, that will show the acceptance by doctors more than anything.