Ann: CE Marking Update, page-52

Yes I would say that. If the data was obtained via a powered randomised controlled trial.
BSI also said that some 3 years ago.

No statistical conclusions are possible with this, or any other pilot proof of concept study.

Who then is "they"? "They" who report such results. Why would "they" draw such conclusions? What have "they" got to gain by making such declarations?

Perhaps these are better questions for investors to ask.

It's very simple, like it or not. Until "they" is the independent clinical advisors and BSI there is and will be no CE approval.