2023 The Final Countdown, page-1260

Actually I don't think that's really the case. It's more like SI and Dr Kurtsburg playing politics in the same way as the trial itself appears to have been engineered more as a way to circumvent FDA approval to provide access to the treatment for her patients. In claiming that it would be unethical she's actually trying to elevate her opinion to a higher level of evidence than it deserves. There was no such claim with the previous Osiris trials which she was also an investigator and which failed to achieve the primary end points so it's completely inconsistent to insist that it's the case. If you look at the response of the various regulators to that claim it's clear they're not impressed.