Hi @Far Away Red, the below is a warning letter on the FDA website - it was sent in April 2024 to a questionable stem cell operator, which supports your point that there are these operators, and there will be one Mesoblast, whose treatment has only got some outstanding CMC items (not “issues”) that they need to look at before it can be approved for use in children with ver poor chances of survival.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safari-stem-cell-llc-661023-04052024
Is it by luck or skill that the company is in such a position and so close to approval?
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