I agree it is unimpressive that there has been no revenue...

I agree it is unimpressive that there has been no revenue despite regulatory approval in various jurisdictions other than the US. I think this reinforces the view that the success of the company turns entirely on the FDA / success in USA.

They used to (may still do, just haven't watched), open investor calls following each quarterly. From those calls, it seemed to me that they have access to very good operators - see advisory board and non-ex US director - in the US capable of commercialising this once FDA in place.

There has been no indication that they have the equivalent capability anywhere else. I suspect that they obtained regulatory approvals globally but would be spread too thin if they sought to monetise fully. They were probably naive thinking they could pull that off.

A guess (again), but I suspect all focus at present will be on submission/approval from the FDA and commerialisation in the US immediately following. Globally, everything will then flow from that.