Replies to post #52833 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Mapman, your theory regarding what is going on, if correct, might be showing up in the trial in a somewhat opposite manner than perhaps one might otherwise contemplate.

I. Most people might/probably contemplate some patients are actually delayed pseudos, but it only becomes apparent they are pseudos at a later time.

II. The other possibility is that certain patients are progressors, and it is only at the time they receive crossover therapy that the progression resolves and/or stabilizes, thus making researchers scratch their heads as well. "Hey Bob, do you think DCVax-L is that good? Jeez Frank, it sure looks like it, but then again, it could have been pseudoprogression."

I'll say it again. Nature might be throwing researchers a curveball, and they'll have to readjust their calibrations to solve it.

I'd suggest again (I think Evaluate has been the lead poster proponent) that the immune response endpoint may become all important in this trial. According to the protocol RK shared, it can be used to support the primary endpoint.

Note: I speculate scenario II above is likely happening more often than scenario I above, only because I think most pseudoprogressors/indeterminates/rapid progressors were removed at baseline I, and therefore because "all" patients seem to be living longer than expected, Crossover treatment may be causing former placebo patients' tumors to stabilize, regress and/or disappear.

If you think about the crossover as doing something we are only really thus far familiar with in DCVax-Direct, and that is stabilizing and/or making progressed tumors regress or even disappear.

So then go back to the statement, "it seems all patients are living longer than expected." The FDA would be sifting through the entire 348 main trial, 32 psPD, 55 info arm, 99 expanded access, German Hospital exemption patients, phase II UCLA adjuvant v. no adjuvant trial, and a few other data sources to determine if Dr. Liau is exactly correct.

Let me end on a positive note here. The FDA would be remiss to take a miracle therapy that is saving lives in a crossover trial they insisted upon, only to revert to another five to seven year without a crossover trial simply because nature is not behaving the way they expect it to.