Saturday, August 16, 2025 8:30:58 PM
First and foremost, the PFS was a statistical guess, but the real results were based on the OS, "THE GOLD STANDARD" data results that proved that DCVax works and that is a fact, no need to run a new trial, IMPO.
The trial was negative. While the original primary endpoint of PFS was not statistically different between the groups (SOC plus placebo vs. SOC plus -L), it was numerically longer in the placebo group. The hazard ratio for -L was 1.1 as well. So the trend was towards harm.
The original secondary endpoint was OS, but it couldn't be analysed due to the crossover. However, we know a number of the placebo control group patients did not crossover. If -L works, there should have been a strong trend towards benefit. But based on the company hiding the data, I am almost certain there was no such trend. I think the opposite is true. There is no reason they could not report the data, other than they know people would not like it. Instead, survival was derived from an untrustworthy (cherry-picked), post-hoc analysis that was implemented and conducted years and years after the trial had already been completed!
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