It's all about the raw data according to FDA Commissioner Califf , which is why three years ago they recommended a trial, without that raw data MSB ain't going to get off first base, doesn't matter what posters here or BP, Endpoints, anyone else, proselytise, whinge, moralise, conspiracy theorise about, etc, etc...they've gotta come up with raw data that's acceptable to FDA Commissioner Califf and the team.
“I think it's so important that people understand this, the FDA is the only regulatory agency that gets a copy of the raw data set and does its own analysis of the data. One of the early lessons for me, serving on FDA advisory committees, was how often the analysis, when you had all the data, drew you to a somewhat different conclusion...So, this independent analysis is a critical function at FDA...”
Edit: I.e. No more tricky attempts at short cutting.
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