As the FDA Commissioner Califf has indicated, it's all about the data, the process to be used to obtain it was previously recommended by the FDA, nothing's changed on either front.
It's all down to SI now, funding looks to be the big hurdle to implementing the process to get the required data.
Good luck all.
"FDA Commissioner Califf:
“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...”
Onward, page-24
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