Yes the post-hoc analysis is far from ideal, but I think the USA results are far more damaging for the prospects of an immediate Phase III trial. Without some sign of efficacy in the US population cohort the FDA is not going to give its approval to continue to Phase III.
I wish biotechs were forced to report the anonymised raw data so we can do our own statistical analysis. We really don't know if the trial succeed or not and we just have to take the word of management. This really isn't ideal.
A question for the holders. Does anyone know the clinicaltrials.gov number for this trial? This should at least give us some idea of the inclusion/exclusion criteria.
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