Trials
I am glad these changes were mentioned. ONC/Y now has some very qualified people who know how best to navigate these matters. So, I am hoping that Noteable is right, and from my lay perspective I think he or she could very well be right.
I am just guessing at the following but is it possible that the confirmatory trial is actually the Phase 3 (albeit much shorter than a normal Phase 3) and the Phase 4 is run with the drug approved. If Noteable is correct Roche would have to be involved