Lets help the process and start NOT making this more complicated than it needs to be , or ALREADY IS.
How many studies are necessary for "clarity" to emerge? That is the ultimate question of whether the data meets the endpoints sufficiently to gain approval.
IMO, RWD and QOL facts is what (probably all) we need from here, along w/solid clinical records and fundamental performance information. Looking for a solution , IN OUR LIFETIME.