I am very positive in regards to the CHF trial for several reasons. The P2 results are nothing less than remarkable. While it is obvious that no one fully understands the mechanisms of action this should not be considered detrimental to the potential similar outcomes of a P3 trial.
This was a very costly trial and the therapy won't be cheap, The DSMC would have been given a futility point that would have stopped the trial above what would normally be considered reasonable to continue.
The trial design is not like your standard trial and the read out will not be either. Take a look at the end points of the trial and tell me exactly what results would course a head line, fail report. It will be reported as a successful trial. The question is , How successful ?
Phase 3 DREAM HF-1 read-out, page-68
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