Or it means that the FDA are not convinced the potency assay actually measures the characteristics that determine efficacy in vivo. So young f the potency assay isn't reliable, then using the same potency assay that was used in the trial 001 wouldn't be able to guarantee that the current or future product is the same. In other words, the FDA still don't accept the potency assay has been validated and the only way to prove that it works is a new trial that shows the outcomes correlate with the potency assay and biomarkers and proposed MoA
2023 Next Steps, page-155
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