It is easy to read into this in a large number of ways, I personally like that the fda is wanting as much beef in the combo BLA as possible. I doubt they are going to approve with mono also not requiring a pivital trial, but I do think the pivotal trial might be much smaller and shorter because of the combo approval.

We do really have to remember this drug is very unique, how many drugs have such powerful trial results and are in the process of trials in other big indications with also powerful signs? Most drugs with multi indications have them because they do not show very strong results and the drug maker is trying to expand the possibilities of other indications to make the drug look more promising. The fda I’m sure feels very confident about leronlimab mostly for the safety of it, they do not need to worry about bad press later on. Even if the delay adds a couple months, the decision on approval could be a couple months faster.