I just want to hear of approval and then watch all the dominos fall in place. What is holding up the decision after all this time?
GGB himself gave you the answer,
-- A 15-year, multi-country, double-blind, placebo-controlled Phase 3 trial—executed across the U.S., U.K., and Germany, under rigorous oversight.
A randomized trial compares patients randomized to treatment to those randomized to the control arm. And that comparison failed to show any improvement in either PFS or OS.
Any attempt to subsequently compare to ECAs is not going to fly. In the words of an RA, the ECA comp will be hypothesis forming.