If you wish to believe some dodgy business owner that was forced to re-locate to the Cayman Islands for fear of being shut down by the FDA, be my guest, and go ahead. It’s says more about that company and its founder that they did this. The whole point of the FDA’s fight against dodgy stem cell operators is to ensure that only ethical companies operate in the US. Regenexx moved for a reason.
You know as well as I do that safety and efficacy are no longer an issue otherwise the FDA would not have backtracked. The CMC issues are what are preventing approval, at present. If MSB have addressed these, in the re-submission to the satisfaction of the FDA, then the big tick of approval will be given.
Time will tell.
Back pain trial, page-26
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