On my point about the FDA possibly not granting the request to go straight to Phase III, my understanding is that companies don't typically go straight to Phase III when they enter the US, hence requiring a "favour".
I get the impression that it's likely to be approved, but that there's more than an outside chance the request will be rejected.
Expanding on that point, for the US trials, apparently they've already got patients identified and trial centres already set up (7 in Arkansas, for example), ready to go as soon as the green light is given and the northern spring rolls around.
agm tomorrow, page-18
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