There's a massive investment required to commercialise it....

There's a massive investment required to commercialise it. They don't want to raise capital so the plan is to partner with a larger healthcare company who already has the necessary infrastructure. They will begin selling it in Europe immediately upon securing a partnership deal (in addition to launching the pivotal clinical trial). I guess this makes it more complicated to negotiate the deal as the deal isn't just to fund clinical trials but it's to begin selling 2RT immediately.

FDA are quite specific with the data they want in the pivotal phase 3 trial. One of their criteria is that the trial is done in the USA...