Replies to post #52835 on NorthWest Biotherapeutics Inc (NWBO)

[mapman1010]

yes i agree that scenario II is most likely the confounding issue that brought about the screening halt as it may not be evident until later in the trial.
i wholeheartedly agree with your last sentence.

[Tony888]

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.

Could you give me a link to where the 32 psPD arm is defined/stated. I can't remember I saw this 32 number anywhere. Thanks.

[beartrap12]

Flipper, Mapman, I have long believed that the expanded access trial was created to capture that evidence that DCVaxL is working well with recurring brain tumors. They already knew there was evidence it worked with rGBM because they had the 51 information arm, so why not gather that info in a trial? I don't know whether that expanded access trial meets the FDA regs for approval to use DCVaxL on rGBM, but if all the information they have on rGBM in the expanded trial plus the main trial's crossover arm plus the info arm point to efficacy for rGBM, I would think the FDA would think long and hard about denying this treatment to patients. Ever since they created that expanded access trial I've thought they may use it to push for approval for not only nGBM, but also rGBM.