DI was correct, just as a general observation. There is no mystery as to what jurisdictions. That people on bulletin boards get confused about such clear matters, is part and parcel of why social media campaigns are so destructive and why bulletin boards often don't inform but actually result in both well-meaning and sometimes less than well-meaning misinformation.
While Europe looks like a unified market still, the EMA is generic and the local jurisdictions still have their own medical systems, healthcare systems and reimbursement approval structures. So much still ends up happening locally, ultimately, to determine if you are going to be approved for use and get paid. Germany and the UK are the major markets that US companies typically look to first in Europe.
The relevant jurisdictions and their local autonomy over certain matters have been discussed for years.
Asian regulators are definitely NOT involved, and we'd know if that were the case because those jurisdictions would have been discussed previously as part of the trial, and that was never, ever the case, though hopefully someday. Japan and Australia would be great, someday. China is a whole other animal and it's clearly not someplace you randomly start talking about at any rate.
As for Brexit, no company is going to start talking about indefinite procedures as it is when that is still an uncertainty. I am very well familiar with companies deeply in the midst of Brexit and they have MULTIPLE plans in process for dealing with contingencies, but they don't spend their days telling everyone if this then that, but if this then this and this... The UK is mired in uncertainty because of Brexit, and that will continue yet for a bit. And even if it is certain they will "go it alone", as it seems is likely, no one knows what that means exactly because it has not been done before and could have myriad consequences.
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