Mav,
If there are no delays in approving the production facility why should approval slip to next year. I know that the U.K. hasn't announced the acceptance of NWBO's application, and even if they've not quite submitted it yet, even a submission in late September could still gain approval in 2022. I believe we're much closer than that, I'd say the odds are better than even that they've already submitted but we'll only be told when they're accepted.
To me the big thing is acceptance of their production capability, once that occurs all else will fall in place IMHO.
Gary