Cabel,

Don did this in the presentation - see slide 13.  If Hospitalization for CHF (congestive heart failure) had been used in place of stroke as one of the MACE components the overall P value for the primary endpoint of the trial would have been 0.02 instead of 0.11.  The trial would have been considered a success.

So, yes, it truly sucks to pick the wrong endpoints for your trial.  I suspect the FDA will be more interested in how well the trial identified the patients in which apabetalone provides benefit (and in which it doesn't) than in absolute P values.  In this respect, we unfortunately have mixed results.  Apabetalone seems to benefit the high risk CKD patients - this is as expected and consistent with the understanding of how the drug acts.  However, apabetalone did not benefit the second group of high risk patients (high LDL) that was also expected to derive benefit through many of the same drug actions.  How this mixed message from the trial gets explained (if it does) will likely be a factor in how the trial is viewed (success or failure) in the fullness of time and in the course of action prescribed by the FDA for moving forward.

Jupe