Ann: Facility Agreement with SIO Partners LP, page-83

As for the competence of WP , I think he and the board expected the EU approval to arrive much earlier than it did .

But is this a question of competence? Approval timelines are unpredictable because you're dealing with bureaucracies that can be capricous. When you have an underfunded company it's going to be a gamble purely because of that fact, and that's the reality.

I also believe they TOTALY underestimated the effects and influence health insurance companies have on what is used in the US market .

Again this doesn't necessarily go to competence. They targetted centers of excellence thinking if they can get the experts in the field (the opinion-makers and leaders) the rest would follow. Health insurers and more importantly, their role as purchasers can have cosy deals with existing comnpanies they won't let go of easily and this is far from about excellence or the best device being used.
This is about entrenched interests, and possible kick-backs and they're not tranparent. Far from it.
Easy to think otherwise though.