Even if all goes well, then there is still the "folks" at the fda to get through, and those protecting a multi-BILLION dollar business, well, I just would put anything past them.
Like an acus, even with an fda approved Ph3, at final meeting, knowing they were out of cash, suddenly bringing up, out of nowhere, they didn't test it against, literally, nothing. My mouth still hits the floor thinking about that open call meeting. I think 17 on panel, many I would guess getting some funding from the multi-billion dollar business they were trying to crack, radiating patients and all, vs. no radiation. Just a guess, that wouldn't really happen would it? ugg.