Replies to post #790727 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Yes, and my point is that while biopsy only patients were excluded from the trial, there were some number with significant residual tumor who were included, and they outlived their ECA counterparts. Why? Because DCVax works.

You fail to understand the numbers here.

In the patients with near total resection, where it was apples to apples, -L showed no benefit. In the patients who did not have near total resection is where -L showed the benefit. But it was in this latter group where all the partials and biopsies from the ECA were. Further, most all (including LL) expected -L to do relatively best in the patients with near total resection.

Look at it this way. Consider 3 groups of patients
1) Had near total resections
2) Had close to near total resections
3) Had partials and/or biopsies

Group 1 will be expected to live longer than group 2 and 2 longer than 3.

Because the -L trial had intent for near total resection it will be comprised almost entirely of 1 and 2, while the ECA has substantial group 3.

The reported MSD was group 1 for both arms. And no benefit. The "substial remaining disease" was 2 and 3. Thus that is where the effect of group 3 not being in -L wiould be seen.

One can reasonably argue the data is somewhat foggy here as the ECA reporting had limitations (the patient level data would be much better). Problem is, burden of proof is on NWBO.

[AllSheWrote]

Pretty wild how we've gone from "cures all forms of cancer" to "maybe has some effect on patients with significant residual tumors depending on how you interpret the data."

[HyGro]

Same bias issue. Since the ECA trials included considerable # of patients with biopsy or partial resections as they were all acceptable for a # of ECA trials. NWBO trial required substantial resection when all or virtually all of the tumor was removed. NWBO deemed some as having "substantial disease" even after the substantial resection -- and many of the ECA patients still had substantial disease after a biopsy, A biopsy removes almost NONE of the tumor.
So that comparison still had bias in the nature of the screening.

This is the reason that FDA requires ECA comparator trials be selected, analyzed, reviewed and approved by the FDA BEFORE THE TRIAL IS STARTED. And why NWBO never filed the application with the FDA. FDA won't accept and AFTER THE FACT ECA.