Amarin Corp Plc (AMRN)

[IslandOfMisfitToys]

Phase II trials are generally not powered to show results with p-values at the traditionally stat sig level (p < .05, two-sided).

p < .10 is more common, as an example. The trials are intended to be hypothesis-generating, informing Phase III trials.

Phase I -- safety, largely
Phase II -- hypothesis generating
Phase III -- for approvals
Phase IV -- confirmatory, long-term safety or effectiveness

Of course, a blowout Phase II result in a high-impact indication like Alzheimers could lead to an accelerated approval, no doubt.