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Re: HyGro post# 500675

Wednesday, 08/03/2022 10:51:35 AM

Wednesday, August 03, 2022 10:51:35 AM

Post# of 822149
Your explanation (cited below) as to what was the cause of the confoundment in the OS arm is incorrect.

NWBO has called their OS data confounded by the crossover as some patients that were DCVax-L dosed were redosed if they were pseudo-progression and therefore received multiple doses. It they had true progression they also had a 2nd dose. That would the confound the reading of the naïve GBM OS arm. That's where the FDA may find the results are questionable because of the multiple dosing that could increase the OS rate. When a placebo treated patients did not have multiple doses



OS is confounded because the randomized control arm received the treatment as well. So the control arm became part of the treatment arm upon crossover due to their recurrent GBM… thus resulting in a confounding of the OS endpoint. It becomes more difficult to compare the two arms when everyone receives the treatment, and for that reason, and in the words of our esteemed and brilliant Linda Liau, “everyone is living longer.”

Additionally all patients (treatment and crossed over to treatment controls) who survived long enough would have received the entirety of all their DCVax-L treatments.
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