He referenced the “gold standard” and the gold standard is double blind placebo not just double blind (and no placebo). Historical control sadly, and wrongheaded is looked down on even though with diseases like FBM trying to use a placebo is not realistic which is why we compromised and had diluted it with a crossover even when the placebo was what we were using.
In short our trial no longer meets the gold standard and we are not sure how serious the FDA is about reform.
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