Wednesday, January 11, 2023 5:33:53 PM
But yet, NWBO post hoc changed everything in the trial -- the protocol, the endpoints, the comparators and the SAP. All the trial had been complete. It is unheard of.
Dr. Liau's 2018 interim analysis publication made statements that they were going to change the primary endpoint. There was already a cherry-picked patient population for recruiting (why the trial took so long), that was not covered when screening for external comparator trials,
The trial failed and they needed to salvage the trial to save the company. Here's a detailed peer-review publication raising considerable clinical trial questions:
https://academic.oup.com/neuro-oncology/advance-article/doi/10.1093/neuonc/noac281/6958519?login=false
Dr. Liau's 2018 interim analysis publication made statements that they were going to change the primary endpoint. There was already a cherry-picked patient population for recruiting (why the trial took so long), that was not covered when screening for external comparator trials,
The trial failed and they needed to salvage the trial to save the company. Here's a detailed peer-review publication raising considerable clinical trial questions:
https://academic.oup.com/neuro-oncology/advance-article/doi/10.1093/neuonc/noac281/6958519?login=false
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