I'm not sure you mean by your statement. Reading the clinical trials protocols, it looks like both stem cell treated and control patients are using current medical therapy (i.e. beta blockers, ACE inhibitors, diuretics, etc). The only difference between the two is one is being treated with stem cells while the control is not.
Based on the Phase 2 results, the stem cell treated cohort had significantly less major adverse cardiac events over 3 years. You have to agree having less major adverse cardiac events is an awesome goal, so much so the FDA has approved that as the approval end point for the P3 trial. Given patients already take current medical therapy, achieving the MACE endpoint means stem cell treatment is better than current medical therapy.
My only question is, I don't understand the mechanism achieving better MACE when secondary endpoints like ventricular volumes and ejection fractions weren't improved.
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