Folks, I now have a chance to digest all the figures in the release.
Here are my thoughts:
The numbers certainly sounded exciting.
We need to the cautious though as they are quoting relative rather than absolute risk, so the significance would also depends on the absolute risk. In other words, of those 500+ patients, a reduction of death from 100 deaths to 40 is much more significant than a reduction from 10 deaths to 4.
Also worth noting is that they chose the NYHA class 2-3 patients as eligible to enter the study, which is not the people with the most advanced disease (that would be NYHA class 4) and therefore not as likely to die imminently. So I suspect the absolute risk of dying for the control group is not too high, and I guess it is for that reason they chose non fatal admission rate as their primary endpoint, so that the absolute reduction of burden of disease is much more significant.
I am a LT holder - all is not lost but FDA will take some convincing!
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