Thanks Mozz! An insightful perspective as usual!
I think the increased blood flow hypothesis is entirely plausible. But if I were a skeptical scientist on the FDA technical advisory panel, I'd be wanting good evidence-based understanding of the MOA. Similarly, if I were designing the PIII trials, I'd want to screen out patients who were not likely to respond spectacularly well to the iPPS treatment. I'd want to be able to identify them with tests devised from a robust understanding of the MOA.
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