Seems the justification for asking for a randomised study was the failure of two previous randomised studies that occured a decade ago with different treatment regimens and the fact that the FDA couldn't work out what an appropriate null hypothesis is - seems flimsy to me and I guess 9 of the ODAC committee agreed that the FDA were barking up the wrong tree. Cest la vie I suppose
Seeking Alpha hatchet job, page-117
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