NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

iclight,

You’re spreading misleading rumors and your statement is incomplete.

Fact ✅️: OS was always one of the endpoints which is an obvious and verifiable fact.

In any study, PFS is either disproven or confirmed by OS if/when OS data are reached.

OS takes longer to discover, and therefore predictive intermediate measures are used.

Page 3 of FDA guidance document:
https://www.fda.gov/media/71195/download


Besides FDA, you can also find it all over the medical literature…






Actual PFS was subsequently proven by the OS data, but the predictive PFS data were contaminated and therefore the investigators could not use the predictive PFS data as a reliable surrogate predictor of OS. Instead, they had to wait for actual OS data.

Oncologists always attempt to measure and predict PFS as they should. Every cancer trial will seek to predict PFS in advance of OS which of course takes longer to discover and confirm.

OS is the ultimate standard, but you cannot wait until death to begin evaluating whether a cancer drug is efficacious. The physician must evaluate a patient’s response and try to determine whether the treatment is helping.

Today, doctors have better methods for measuring progression, particularly when studying immunotherapy agents which are still relatively new as the emerging field of cell-based science is leading to rapid changes in the understanding of how cancer can be assessed and treated.

The P3 for the DCVax-L cell-based technology spanned many years. If the trial were designed and commenced in 2024, the investigators would appropriately attempt to measure progression and predict survival using the best methods and most current medical knowledge available in 2024, as any cancer researcher would.



https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847