I don't know. I find the statements from SI very confusing compared to the previous announcement that the FDA still wanted a well controlled clinical trial in adults. Now SI appears to be trying to walk that back and is saying that it was just about ensuring the potency of existing inventory is the same as that used in the trial and they can "generate more data" to show that it is? And that it was Mesoblast that proposed doing a trial in adults?
It doesn't seem to completely "align" with the last announcement. Although it does tend to align with the reluctance of the company to actually do a properly controlled clinical trial, and perhaps they are still looking to avoid this if they can?
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