Adaptive design - glad to see CD-12 has that in the clinicaltrials.gov description. Per the FDA document (thanks!), that means the criteria for an early read-out were prospectively-agreed, complete with auxiliary statistics analysis plans, indicating it should be on auto-pilot, though we don't know those details.

Most interesting subtlety: the interim review would look at "treatment A" vs. "treatment B," making comparisons that don't formally have info which is leronlimab.

NP has also used the phrase: "calling a data safety monitoring board meeting." I don't know if that is meant to be under this guidance or is separate. I think I heard a DSMB ends the study immediately.