Well it is not possible to know what the FDA looked at and how they arrived at their position ... I can only imagine they looked at each DP and categorised them by the amount of TNF1 ... there may have only been a small variance between the subgroups, but they may have tried to see if a higher concentrated TNF1 DP resulted in a better clinical outcome.
I think the only way to know is to possibly give a large cohort a dose from a DP with significantly lower concentration of TFN1.. and the other cohort gets a high concentration DP.
Mesoblast were able to demonstrate it in vitro, but the trial wasn’t set up to demonstrate this in vivo
FDA ODAC Meeting Material discussion analysis, page-375
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