Indeed the FDA were very clear - Dr Bauer was kind enough to spell out what the OTAT were looking for in public and in detail across 9 pages (pages 83-92 I believe) of the document.
MSB after spending $10m on this really have no excuses left but neither does the FDA - if after spending $10m on potency assays that the FDA apparently believe are "reasonable based on in vitro results" the FDA deny MSB then what state does that leave the interests of other cell based therapy companies?
MSB Trading 2021 - paradigm shift, page-7847
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