From what I can tell is that the FDA is not doubting that the treatment works... but that is not enough,
''The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity''
They want to know the specific active characteristic or exactly why its working and want to understand how they can determine effectively the potency of every dose. It's not enough for them just to show good outcomes
I guess its part of being on the cutting edge of medicine... You understand something that the rest of the world who you need for acceptance don't get it yet.
From what I can tell is that the FDA is not doubting that the...
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