Replies to post #764016 on NorthWest Biotherapeutics Inc (NWBO)

[Margin Buu]

You are correct. Ex lies by omission.

Challenges with assessing PFS, particularly due to the phenomenon of pseudoprogression (where immune responses can mimic tumor growth on imaging), led to difficulties in reliably measuring PFS. As a result, the trial's focus shifted, and Overall Survival became a more emphasized outcome in later analyses, especially in the final results published in 2022. The study design was adapted, and OS data were compared against external control groups due to the crossover design, where nearly 90% of patients, including those initially in the placebo arm, received DCVax-L after recurrence.

The shorts have argued the placebo patients should have been left to die for the sake of maintaining a control, even once it was realized how much greater the chances of survival were when DCVax-L was administered.

[exwannabe]

Why are you ignoring the fact that 90 percent of patients in the trial were treated with DCVAX? There is no control in the trial.

99 patients were assigned to receive placebo until progression. That is the control arm. This is clinical trials 101.

If Merck runs a first line trial with K where it is already approved for second line do they cry foul that the trial failed because most all control took K after progression? No. But you are doing exactly that.

That post progression treatment confounds OS is a problem, Life is a bitch. Design better trials.

The P3 was designed to show PFS. As such the crossover did not matter. That was all on NWBO.