Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-133

Gotta laugh as you are not being mindfull of a few things eg

1) the very strong p value for pain releif at 12 months
2) the alarming opioid abuse problem in the states leading to
3) pressure to ''do something''
4) the incoming head of the FDA has point 3 as a major focus
5) the incoming head of the FDA wants to speed up approvals
6) a halt due to overwhelming efficacy stats is likely quite early in the piece given the strong p values obtained previously.

The p value will enable ''doing something'' quicker then normal time lines

I think that’s just legalese for please don’t launch a class action if things don’t go according to plan. I wouldn’t use it as a barometer for anything else.