It looks like one of the reasons MSB got knocked back by the FDA is because that they need to do a RCT randomised controlled trial. Wasn't this also the same reason for their rejection back in 2020? I think back then they were advised by the FDA to do an RCT. For this reason in my opinion, this is not a knock on MSCs in general, it's simply to do with MSBs chosen path to approval which didn't address one of their concerns, another concern of course may be the batch to batch donor variability safety concerns that Cyanta addresses so beautifully.
Cyanta's phase 2 is RCT btw i.e listening to and addressing the concerns of the FDA.
It looks like one of the reasons MSB got knocked back by the FDA...
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