"Sometimes the question...is it's own reply"...damned if it isn't...I have never believed the FDA was moving the goalposts...as many have asserted...IT is rather "the proof is in the pudding"...show us your pudding.
I see it as HIV...Mash...and Cancer...in that order...albeit the order could enhance in a different timeline... ALL predicated on the partner/suitor agenda/priority .
This, at sometimes rudderless ship...is not in the water by itself.