NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

OS is a “real endpoint”, PFS is a surrogate or proxy measure for OS that often may not actually be a good surrogate measure, which is why it is often required that for drugs, companies prove survival benefit or some other real benefit later.

And by the way, you keep pretending OS was THE endpoint for Optune, it was secondary. PFS was their primary, which is why the trial ended early and why they did not keep it open to show actual 5 year survival. They were also not blinded, apparently. So your constant refrain that the NWBO trial was “manipulated” and then comparing to Optune is always so thoroughly bogus, since optune is a device and simply did not need to meet the standards of a drug.

OS was originally secondary for NWBO, but before they unblinded, they had the right to change it. They actually have the data on real life survival. It is not projected from assumptions about PFS, which it turns out are frequently wrong due to pseudoresponse.

One trial has real survival data, for a disease that to this day is almost always fatal. DCVax-L.

Running the trial out, as the patients are enrolled, so that there is an actual measure of survival, takes a long time, a surrogate measure presumes a connection and uses PFS to estimate survival. That’s why sometimes it turns out though, with pseudoresponse, that it is often a bad measure for survival.

Only DCVax-L ran its trial out long enough to get actual 5 year survival. Period.

The Optune trial was a very large trial, many more patients were in it, and I think it ran, from beginning to end, 6 years, or so. You can’t actually measure 5 year survival when a trial that large ends early like that, unless you use a surrogate for OS, which is what they did. It being a device, really, the regulations are low and they don’t need to meet further standards for a drug.