Yes, this has been mentioned many times now. But that's not how controls work, as it's now a larger trial with a different population. It's a different study. So because it was used as a control previously doesn't mean it shouldn't continue being the control.
Consider this, we have seen many phase 3 trials now that don't support the original findings of the phase 2. Why would that be different for controls?
Keep in mind, they did use just the cells by themselves in the phase three trial and found no significant effect.
The only significance was found when HA was used. They can't prove it isn't the HA having the effect the way they planned this study.
If you think I'm just making this up that's fine, believe what you want. Trial design is complex.
MSB 2022 - The road to commercialisation, page-690
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