Clinical read The ballot was the outcome. Capricor’s application is for cardiomyopathy, but HOPE-3’s primary endpoint was upper limb function, so the committee voted on the cardiac case and only discussed the muscle case, where its feedback ran supportive. A drug’s strongest dataset sitting off the ballot is not a procedural footnote, it is the whole result. Nine to three is what that construction produces. This is also the second round of the same argument. The FDA issued a Complete Response Letter in July 2025 over HOPE-2, and the dispute then, as now, was less about whether patients improved than about which statistical analysis plan governs the answer. Two trials, two fights over the analysis, one consistent agency position. The pattern is the signal, not any single p-value. The access half is harder. DMD cardiomyopathy is the leading cause of death in the disease and has no approved treatment, which is close to the strongest unmet-need argument available anywhere in rare disease, and it did not carry the vote. Unmet need is not currently substituting for statistical clarity at CBER. If the FDA approves anyway by 22 August, read the label before the headline: a narrow cardiac indication with a 9-3 negative panel behind it hands payers everything they need to restrict a repeat-infusion allogeneic cell therapy. And the Rare Pediatric Disease designation means a priority review voucher rides on approval, a balance-sheet event for a company this size regardless of how many patients are ever dosed.