If the science is false, why isn't it being challenged?, page-41

You guys understand that this is an interim analysis for futility? That's an incredibly low bar.

To meet a primary efficacy endpoint at the end of a trial, you need to gather enough evidence that on that measure the treatment wing is (statistically) significantly better than the control wing, usually at a p<0.05 level.


To cancel a clinical trial for futility, you need to prove to a similar - often higher level of certainty that the endpoints can not possibly be met. That might mean there is a only a 6% chance that the endpoints will be met, and all we would hear is 'the DMC recommended the study continue on protocol'.

In that case, all we would know was that there was somewhere greater than a 5% chance that the trial might meet its endpoint - and more than that, we'd know that if MSB wanted to continue, they'd have to fund it themselves.

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What I have been saying is that the probability that the CHF trial succeeds is diminished (or more accurately not enhanced) by the Phase II results. This was in a direct response to Anjo-Roch who claimed that the Phase II trials showed a strong efficacy singal. As per @Southoz above, the independent peer reviewers of the phase II results thought that was nonsense.

I stand by my analysis.