The known problems in US approval may be less than the known...

The known problems in US approval may be less than the known problems we had in the EU process.
(rmemeber the EU process looked like a (doddle/walk in the park) before we started it.
When we get to near the and of the US process and all the currently unknown stuff comes up you may have a differing view.
On the other hand having been through the mill in the EU process may mean TIS gives all the right answers during the US process, and no issues will now crop up... but they would have cropped up if we had gone the US route first. So I wont even regard a subsequent breeze through US approval to mean it would have been easier in the first place.

Irrespective. Even with the trial results we had and the information we had, to go the US route there would have to have been a double blind trial, and significant extra expense, and that was all before we could actually finally apply.
I believe the experience of the other companies and products that brought stuff to market before also indicates the EU route would be best route for us, and then there are the

I rather like the reassurance that, expert and influential wound clinicians, who were (IIRC) part of the case studies and hence have a seen it with their own eyes kind of evidence will be in the jurisdiction where they can purchase use and then endorse, the effectiveness of vitro gro. That will go long way towards the next hurdle of getting it (subsidised as a standard treatment regime) in the EU market. (AKA not only approval to sell, but fast and deep market penetration.)

The EU route still seems like a no brainer to me.