In a recent executive perspective, “Approval Is a Milestone, Access Is the Mission,” Lumanity’s Katie McCarthy made the case that strong data doesn’t defend itself. The narrative around it does the work, and that narrative has to hold up not just with the FDA, but with every audience that follows. Capricor’s deramiocel is the example she used to make that point: a panel that voted against approval not because the underlying science was in question, but because of how the statistical analysis and missing-data assumptions were interpreted under scrutiny.
That case highlights a challenge every sponsor now faces: building a defensible narrative that holds up at an AdCom, even though whether you’ll face a panel, and what kind, is harder to predict than ever.
That’s the question this piece explores.
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