What you are missing is "the good 'l SI Spin".
They just want "more data", not really another trial in adults...
"The FDA just want "comfort" that "the potency of the current inventory matches that of the trial 001".
Not exactly, I don't think that's what it's really about. Trial 001 was completed over 3 years ago, but it's also not certain that the potency assay actually measures in vivo potency... So the FDA has "acknowledged that the potency assay has been improved", but not that it has been satisfactorily validated to be an accurate measurement of efficacy in the human body. To do that you need another trial to show that the potency assay actually does correlate with biomarkers and outcomes and in the process helps validate the theoretical mechanism of action.
So generating some more data won't be enough. That's not what the FDA wants. Only a new trial that shows everything working the way SI claims it does will do.
Mesoblast CC Transcript 31/8, page-49
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