>>may I ask where is it officially stated that the FDA deemed those older trials as being unreliable?<<
Please see the third-to-last paragraph in #msg-4483514, which is taken from GTCB’s 2001 10K report. (The text from the 10K does not use the word unreliable, but that’s the gist of the discussion.)
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”