NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

TTP in that paper was specifically back dated to include TTT. The study was very clear on that. That study too starting measuring efficacy at BASELINE. If it had reported PFS, in days, it would have used BASELINE. There was no PFS in days on that chart. How they report and how they measure are different things. They measure progression the same way this Phase III does: from BASELINE.

3.1. OBJECTIVES
3.1.1. Primary objective
The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort in patients with no evidence of disease progression at baseline.

3.1.2. Secondary objective
The secondary objective of this study is to compare Overall Survival (OS) between patients in the DCVax-L group and patients in the placebo group in patients with no evidence of disease progression at baseline

And BASELINE MRI is about 1 week before injection day 0 in this study. There is time to treatment necessary to make the vaccine; and also to treat the patient. It is impossible to truly capture progression from surgery if they need time to make the vaccine as we know they needed to in Phase I/II:

DCVax-L. Both DCVax-L and the placebo are tested at the contracted manufacturer prior to release to the study site. Patients for whom sufficient DCVax-L was not
generated are not eligible to continue on this protocol.
All subjects who had a leukapheresis will undergo external beam radiation therapy (which may include intensity modulate radiation therapy or IMRT) and concurrent temozolomide chemotherapy as part of standard primary treatment, initiated as soon as possible, typically 3-4 weeks after surgery (Appendices A & B).

Two weeks after completion of radiation and concurrent chemotherapy treatment,
subjects will undergo the Baseline Visit, during which the final tests to determine eligibility are performed. Patients who do not have obvious evidence of progressive
disease at the Baseline Visit (as determined by MRI) are enrolled in the main arm of the study (intent to treat), and are randomized to receive DCVax-L in the treatment cohort or autologous MNC in the placebo cohort.

Randomization and treatment
assignment takes place within 1 week of the Baseline Visit. At the Baseline Visit, patients must be scheduled to return to the clinic 1 week later to receive their first immunization.

And obviously since TUMOR progression is MEASURED from BASELINE if the Phase III study were to REPORT data from the median newly diagnosed surgery the Time To Treatment (TTT) would need to be added back in, the same as the N=8 had done.

In the Phase III trial, PFS and survival times will be calculated from time of randomization, which is expected to occur approximately three months after initial surgery.

This is such a simple concept, it shocks me that you don't get that measuring and reporting progression do not include TTT the same way. You seem hung up on the idea of discussing it again and again, and confused by it. Have you considered my advice to go to UCLA?

BTW, she compared that Phase I to both historical and concurrent protocols. But that doesn't mean the Phase I patients had STUPP protocol. You are suggesting they recurrent survival seem then should compared to current day survival which I remind are privy to STUPP. Considering these patients did not get STUPP protocol, they did well IMHO. As for the rest of what you wrote I will review later when I have the time.