Tuesday, May 13, 2025 4:35:22 PM
Bunkum. If you knew the history of this trial as well as you pretend to know, you would know that it was, as has been pointed out ad-nauseum on this board, the FDA that required control arm patients to be crossed over to the treatment arm when they progressed, thus introducing the confoundment that you decry. So, it was not introduced by NWBIO but effectively by the FDA.
A) The JAMA paper says otherwise. The crossover was allowed based on it being a carrot for enrollment. Are you saying the 72 authors lied in that paper or what?
B) That design in question was for a small P2 not designed to demonstrate OS efficacy. That NWBO repuposed the trial into a P3 then changed OS to the primary was on them.
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