this makes sense to me
The more I think about this, as CEO I'd want the earliest data possible, especially if I'm concerned about FDA decision on Anchor eroding my ability to fund ops.
I'd be inclined to submit a change to the trial power. I'd even go so far as to get a 3rd party biostatistician to study the data and determine trending data, using predictive analytics. If Vascepa is working as we expect, and patient pop is as sick as we think compared to JELIS, then compelling data might be closer than we think.
What would happen if FDA agrees to something less than 90%? Say 80-85% power? That should make Reduce It data available much sooner - right?