Feasibility studies with life human participants are just a possibility at this point - a confusion inspired by confusing FDA criteria. They're just getting ahead of the eventuality, trying "to get things right" and dealing with it the best way they can.
It's not such a big deal as compared to an actual human trial, which is very costly, and would lead to a lot of delays. This was actually at one point in the timeline during Fowler's time, but since then, FDA regulations have relaxed a bit, as long as we're judged to a predicate device.
"To get things right" is pretty much Mac's focus, and to do so to the extent he can get away with, with investors and his eventual legacy.
There's no other conspiracy here, and the fact that it feels late to the game, only reveals the inadequacies of previous planning and previous management. There's nothing more to it than that.
It's people, people, with all that it entails. No deep state, or anything like that.
I had the feeling this was coming ever since that postcast awhile ago, and I posted about it before, in which McNally stated they really want to get this right, and if it takes a little bit longer, then that's okay.
He was referring to the timeline that was changed from previous management, and not to the current change in timeline, but that comment (judged as Flenderson's insider as misconstrued) was enough to convince me that he has absolutely no qualms about delays, as long as it is for the sake of the longer term pay-off. He'll do it again if he has to.
So here we are, with a delay, and a better longer term pay-off. Take it or leave it, it's not that much longer to begin with and relatively minor. Either way, nothing other than that is going on here.
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