All very fair comments, too. Obviously the phase 1 trial wasn't powered to show efficacy, but we're in a situation that - while not unique - is not the norm either. That being our phase 1 study was conducted in patients with the actual disease indication we're studying, not healthy volunteers. As such, we can see how the drug is behaving in the real world (rather than simply observing biomarkers as a proxy), but we don't have the benefit of the placebo arm to compare to. Hence the PRO-ACT comparison.
Cheers
Densy
All very fair comments, too. Obviously the phase 1 trial wasn't...
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