ABT tried the same kind of “overpowering” pooling ploy with Xinlay, but it didn’t fool anyone on the FDA advisory panel (#msg-7720638) nor did it fool anyone at the FDA itself.
I understand that for the present trial there may well be no clinical significance even if there had been borderline statistical significance. But if the intervention is in fact doing something, then a longer trial on earlier patients may indeed show clinical significance. It might even be that if they continue to follow these patients they will see a clinically significant effect. Or maybe there is some subgroup for which the drug works well.
My point is that I don't think this drug is yet dead.
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