Okay, lets see how the panel will discuss these points:
Point 1-3: patients from 001 trial used the same lot of cells. thus, there is little variability of TNFR1 expression in the same lot of cells. the outcome (ie: responder vs non-responder) might be purely attributed to variability in patients and their immune system and disease severity/stage.
Point 4: Significant was observed (as shown by SI) the optimized protocol produced better outcome. But importantly, TNFR1 expression level correlates with survival/better outcome.
Ryoncil: ODAC/FDA Meeting Discussion, page-402
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