the FDA’s conclusion and position is that they could not find any relationship between TNF1 and clinical outcomes.
I don’t know for sure if the FDA has looked at the latest document from MSB before putting out their briefing notes... but my main focus is on what the FDA say as they are the regulator. And their conclusions and positions are stated pretty clearly in their briefing documents... at the time of writing their briefing notes, they could not find the relationship between TFN1 and clinical outcomes.
in a sporting field, the players can argue all they want.. but if the umpire says it’s a penalty or goal.. it stands... and in this instance the ODAC is the third umpire and it can give it’s view.
FDA ODAC Meeting Material discussion analysis, page-362
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