CAPR · Capricor Therapeutics Inc.
AI read · Bad for CAPR
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That leaves the approval case weaker. FDA staff said the HOPE-3 results, read with HOPE-2, do not show substantial evidence that Deramiocel works. A July panel also voted 9-3 that the evidence was insufficient and cited changes to key analyses after the trial ended. The extension results point the other way: arm-function loss slowed in the delayed-start group after it began treatment, and the early-start group’s scores changed little between years. But the FDA’s concerns about whether the combined studies prove the drug works carry greater weight as its decision approaches on November 22.