Looks like the study has only just gone up on the register last week.
It's listed as Phase II/Phase III, not just just Phase II.
I know they probably intended to sort out the EU application quickly(!?!), but it is frustrating that the original trial design wasn't of the standard (double-blind, placebo, 250 patients) they would require for FDA application.
Easy to say in hindsight I guess.
Well done Steve and team !, page-39
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