risk and reward

Without delving too much into this, it seems to me (from what I have now read) that US FDA trials were not much more effort (time and money) than the Euro device trials

and it also seems to me that the FDA trials would be far more beneficial to the company in the long run

Considering that it seemed to be well established that device classification was a very grey area right from the very beginning, then I can only conclude this was a huge gamble (comparatively speaking) for very little benefit to TIS. The risk/reward simply wasn't worth it.

I know this is twenty twenty hindsight, but it seems pretty basic stuff for someone at the coalface to make a judgement call at the start, it seems to me all key information to decide this path of execution was well known

If what I am saying is true (and I'm not saying it is), then the board need to go in my opinion