Most definitely noticed that, but a quote above rings true... Mesoblast were mining for silver and struck gold instead.
60% reduction in MACE (stroke/heart attack) across both class ii and class iii patients.. and 60% reduction in cardiac death in class ii patients. That was a huge surprise, and unpresecented.
It sounded like Mesoblast were very surprised themselves and probably don't know what exactly to do with the data or how the FDA / partners would react to it... you just don't see these type of results at all... nothing has ever come close to it.
the rationale of using recurrent hospitalisations as a primary endpoint is that it was believed to have been a surrogate / predictor of cardiac death... but recent trial results and today's appear to suggest otherwise.
we've seen trials that have met their primary endpoint or reducing recurrent hospitalisations, but had no or little reduction in survival... and those treatments were dumped by their partners.
and today we again see no correlation of recurrent hospitalisaions and cardiac death ... and cardiac death is the ultimate end point, however it is financially not feasible to conduct a large scale phase 3 trial using cardiac death/mortality given it would require many more patients in the trial to show up as a statistical clinical benefit (hospitalisations, and MACE events occur more frequently, so require less patients/events to calculate a result.. whereas cardiac death may take a long time and one patient can only count as one data point/event).
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- Ann: Mesoblast Phase 3 Chronic Heart Failure Results
Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-371
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