If the MHRA approves the production facilities, the only holdup from the FDA that is possible I expect would be whether Sawston alone is adequate for initial approval in the US. In that instance, I do not, honestly, expect there to be any “problems” or holdups except their capacity to meet demand.
As for the pathway to Project Orbis, that comes through ILAP potentially, as was well explained and documented not that long ago by Hoffmann here. If they get into that program, I believe the approval will be relatively rapidly global (those decisions for non-COVID, still can take a while), and I think the likelihood of being in Project Orbis is high. Relatively rapid, is a key phrase. But I think they seem to be working well with the UK as proxy for the Project Orbis process.
This is an orphan condition, with orphan status, for an almost 100% fatal disease. They have a substantial improvement alone for recurrent GBM, a condition for which there isn’t even a current standard of care. Not to mention the huge improvements for newly diagnosed GBM. It’s a major breakthrough, but of course being able to make a drug / treatment like this is critical. It was not, however, a barrier to approvals for Car-T, which treatments are, as of yet, still not fully automated and in short supply.
The other issue is they likely need resources, and the Preferred C shares plus pending other events could likely shake a lot more loose than people realize. All IMHO. And of course with substantial soft prognostication.
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