Nice interview however the CEO didn't explain FDA's question about the manufacturing process.
"Studies have shown batch to batch variability in MSC's taken from different donors and expanded under different conditions.
How Sponsors / Donors have defined manufacturing process and described MSC's in regulatory submission to the FDA?"
Who are existing donors and where are new donors coming from to support the company in a process to make a product in the US in light of a pandemic travel restriction?
The product was absolutely fine.
MSB Trading 2020 - a new dawn, page-3647
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