You said, "autologous Mesencymal stem cells, amongst many, many other applications of and types of stem cells have been in use commercially for years in multiple countries, approved by the FDA and EMA for example."
Unless I missed something (possible), the FDA has not approved an MSC therapy, either autologous or allogeneic as yet. NurOwn, the latest autologous MSC treatment (in ALS) got knocked back late last year and just recently agreed to a further Phase IIIb study for a future BLA application.
Special Access Scheme would not fall under "in use commercially" and does not require an approval such as a BLA.
I'm not trying to mix any words and apologies if I am oblivious, but I am aware of FDA approved stem cell, but not MSC products, which is one of the reasons why MSB's pathway with the MSB has been a rather lengthy one. Future MSC therapies are likely to benefit from MSB's pioneer work, funded by its shareholders and uni friends.
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