Exactly, this is the post I was agreeing with earlier and by mistake replied to another. I think they are likely in process already in ILAP, most likely, and a rolling review is very likely.
Now it may be that there are variations on this process if a company wants to submit to multiple jurisdictions at once and utilize the various programs that the UK is a part of, which can include the Access Consortium and/or the introduction to Project Orbis, though Les’ appearance suggests they may have a separate plan to approach the FDA directly for approvals so Project Orbis may or may not be immediately on the table.
But the Access Consortium could also expedite a larger market access.
I said long ago I thought they would want to validate the automated manufacturing prior to approval because it is easier to do it that way, still lots of work, but easier than if they did it after the fact.
So I think we are very much similar in our thinking.