Agreed ... but it is is far from common-sense to understand conceptually why in a P3 confirmatory trial you have a hierarchical structure of outcomes. And when the primary outcome fails statistical significance on your secondary outcomes is meaningless.
You would have to write a book to explain why this is so.
But on your second point about a terrible choice of outcomes … I would disagree agree slightly. The outcomes for CHF and LBP were not bad per se. Rather it was the process that generated them which was flawed. So I agree with dplanes point about overconfidence on weak P2 results.
The trouble is running P3 trials as if they were exploratory P2 trials – to learn as you go and to generate interesting sub-group efficacy signals on different endpoints for later testing in ……more P3 trials is completely un-viable.
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-290
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