Looking at Humira's original BLA filed in 2002 (125057) and then it has 53 Supplemental labels attached to this same BLA (125057). I did not look at the labels to differentiate, but this is how I thought the leronlimab would file their BLAs (original BLA for combo and then all other leronlimab indications would be supplemental filings). I know the clinical trials would all be independent, but IMO supplemental labels would be easier, less paperwork as the non-clinical and CMC portions would be largely the same, cheaper, and faster approval.

I am missing something or do you agree?

https://www.accessdata.fda.gov/scripts/cder/d...lNo=125057