The FDA will assign that to a cohort of doctors wh

The FDA will assign that to a cohort of doctors who have "expertise" in that particular field. They report back to the lead (may have been Strayhorn) who should abide by their consensus. In our case those doctors should be specialists in virology but I have a suspicion that leronlimab being an HIV drug they may have passed it off to the same people already handling our HIV trials.