EMA Fails to Follow Legislation and Its Own Policy, page-17

Much deleted above.
I do see that, people are emotionally invested, I have to slap myself sometimes.
(though lately it more put cushion on the desk to save my head)

However, you say "If the US FDA trial ever goes ahead, "
umm errr, if the stuff gets CE in EU.
There is an income stream in the EU
Cost benefit, of also selling in the US mandates, going down that route.

Not sure, the "If the US FDA trial ever goes ahead," really properly and fairly characterises that as the only real impediment would be cash flow, from EU sales.
I dont know how it works, but being on sale in another area, I think kind makes it easier to get ethics approval and do the study on patients in the area where its on sale.
I might be wrong perhaps FDA thinks USians are special enough you have to test on USians... but Id be guessing, the EU doctors that ran the first trials would be up for doing the study and publishing the papers.

and its been costed...

I know you're upset with the upbeat tone of the thread, but perhaps you're overcompensating a touch?