I will answer your question again. Name a drug that the active ingredient cannot be measured? That is the answer to your question.
The FDA want something to measure. Stem cells are not a drug therefore it needs a whole new method of measurement. How to ensure batch to batch consistency. SI tried to explain this but the FDA could not get their heads around this. Perhaps the meeting higher up in the chain of FDA may help with this. Time will tell.
Ann: DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial, page-288
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