Most will admit that Regen's (i.e., Koos') inexperience has definitely shown over the course of HemaXellerate's lifetime. Lucky for us, the FDA seems to be holding their hand through a lot of this. As far as I can tell, there is no "3 strikes and you're out" policy, so as long as Regen is willing to make the necessary corrections (even if that requires a bit of backtracking), it has a good chance of getting approval, even if it will be 2+ years at that point.
I also have to imagine this process has been quite the learning experience for them, and it's clear that the company is the most structured and capable it's ever been.
$ RGBP $