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Wednesday, January 05, 2022 8:05:47 AM
Because the last 32 patients went on drug, and placebos all likely crossed over after the Aug 2015 halt in placebo meaning the last 3 months of enrolled placebo probably crossed over to DCVax before progression, the people marching from 1.5 to 3 years in 2017 to 2018 were highly enriched with DCVax. This is supported by the 85% treated number growing to over 90% in this time frame. This means that there is a high probability that the difference seen year 2 to year 3 is attributed to this enrichment at enrollment and over the past few months of non progressors.
What was the Intent To Treat those that crossed before progression and which arm do you place them in when analyzing the original cohorts if at all?
It wasn’t a mistake that switched their spots, it was the intent to move them to the treatment group. Those are questions regulators probably debated.
The original data set may be 232 vs 79 or even possibly but not likely 252 vs 79.
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