Exactly. The treatment administered to the previous patients didn't undergo any approved potency assay, so there is no way to know the activity of what went in. And it may even have varied between individual batches or each patient or over time. That is if the potency assay is actually measuring invivo efficacy.
Surely the FDA is going to say use a potency assay that has been approved and then run a new trial to demonstrate that it works.
MSB 2022 - The road to commercialisation, page-1349
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