I think this draft guidance will be welcomed by many trialists because it certainly makes sense imo.

When a drug like ABL has been shown to be safe and just misses P<0.05, and there is an a significant unmet need, I would like to think the FDA will exercise this new flexibility. But at the end of the day it will come down to a subjective consensus of a bunch of people around a table, some of whom may vote one way, and some the other.