Ok Planning is underway. That's not a commitment yet in my opinion to doing a phase 2. Its just considering it, getting ready.
There's a thing called a feasibilility study that I would do in Ross's position prior to doing a proper plan. A proper plan involving full costings. A feasibility study just quickly looks at the key success factors to see if they can be met. Like recruiting 60 in a reasonable period when others like MSB may also be trying to recruit for say a phase 4 - adult confirmation.
If you need 60 patients look at the feasibility of getting those 60 patients from specific clinics based on their historical records of treating people that end up getting GVHD.
If you can't find 60 patients to be a likely gettable number from a doable number of clinics in a variety of countries including the US, Australia, Canada and some others then you don't start the trial.
Before full planning there is planning the plan. A feasibility study is a right sized approach - not in my opinion opening an office in the US as you've suggested that is an expense that has to be justified. Maybe it would be justified if it was necessary to build relationships with clinics in the US - maybe that is why SI has an office in the US rather than that the FDA needed him to.
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