"FDA approval is pretty much a rubber stamp in this case..IMHO"
IMO, this sort of thinking is flawed at any time for any NDA/BLA. But I am completely at a loss how you can make such a statement given the recent (last 3 years) inconsistencies within drug approval applications in the US and the fact this will be a first filing for a new technology (in US) and comes from a tiny biotech with no other US approvals under its belt.
But then again quite a few things you write make no sense to me.