So I can tell people don't actually read what is said here, as I've said why that doesn't really matter above.
The truth is they can do whatever control they want to do. But using a control in a phase 2 trial does not mean that control is unnecessary in a phase 3 trial.
They could use saline as a control sure. They could use HA as a control.
By using HA, they could say "we know it's the cells, or the cells plus HA, rather than the HA alone. This is why you should approve/use our expensive therapy".
They can't say that now. They can't isolate the effect of the cells from that of the HA.
Why didn't they do that study? The money? HA isn't expensive, at least compared to the price of doing an inferior study.
So why not?
Maybe they aren't confident the cells will have a significant effect compared to HA. Also why they likely didn't compare to steroids, the standard of care.
Maybe there's other reasons. But I'm extremely suspicious, and the FDA and other clinicians will be as well.
Disagree all you want. But just be wary, and don't believe all the hype you read here.
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