"Primary gain is ours as a society. Children having the opportunity to survive & thrive. Parents buying their children toys rather than having to choose a coffin for them. Because that’s what in reality it actually comes down to"
No it isn't, because even with the favourable outcome touted by SI, survival is still only 50% not the 100% you are implying, and even that outcome wasn't supported by the results of the two previous RCTs carried out by Osiris. And the p value of the open label trial depends on the hypothetical control group that is different depending on which study you choose to quote. The Osiris trials had favourable phase 2 trials as well that weren't confirmed in the phase 3 RCTs. That's what concerns SI and its the real reason he doesn't want to take the chance on a proper RCT. Really the aGVHD trial is of a size, design and quality you would expect from a phase 2 trial not a phase 3 pivotal trial for the FDA.
Just to remind you of the outcomes of the Osiris trials
https://www.evaluate.com/vantage/articles/news/osiris-left-clinging-niche-after-prochymal-failure
2023 The Final Countdown, page-1246
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