Replies to post #509214 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

simply bullshit and against everything every doctor has said about the way this trial operated.

see the red for one such doctor's presentation

[Dr Bala]

Confounding after a highly successful P3 trial is an impossible task.

[MasterBlastr]

LOL, HyGro.

by.

[biosectinvestor]

Incorrect again Hygro. The interim analysis was not undblinded so PFS was not an issue in that context. The focus was on OS/mOS. They did, in fact, reference the potential for confoundment and that PFS was not yet evaluated, but would be subsequently. The focus was OS/mOS and the company had said for quite a long time that their focus was the “long-tail” of survivors and that that could be the key to a “home run”.

2018 you said? This is THE analysis from 2018, and everyone is a signatory, and Dr. Liau is likely a primary author if not the author of the results. This was the published interim analysis from 2018:

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

“Assessments

Baseline assessments included physical examination, neurological examination, vitals, KPS, MRI of brain with and without contrast, hematology (CBC with differential, platelets), and serum chemistries (calcium, magnesium, SGOT, SGPT, alkaline phosphatase, LDH, total bilirubin, BUN, creatinine, electrolytes, glucose). Blood was collected for serum markers of autoimmune disease (anti-DNA) and immune monitoring, at the baseline visit and at treatment visits throughout the trial. MRI brain scans were performed every 2 months, per SOC, after the baseline MRI until radiological tumor progression. All MRI scans were evaluated centrally by 2 blinded independent radiologists, with adjudication by a third such radiologist if needed.

Adverse events were recorded prospectively according to the National Cancer Institute’s Common Terminology Criteria (version 3.0 NCI CTC), until 2 months after the last study treatment. Patients are followed for OS until death.

Statistical analyses

The study’s primary endpoint is PFS, and the secondary endpoint is OS. PFS has not yet been evaluated for this publication and will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon. Analysis of the blinded interim data on OS of the ITT population (using SAS version 9.4) was performed 34 months after the midpoint of patient enrollment, and 16 months after the last patient was enrolled and randomized.

General descriptive statistics include the number of observed values, mean, standard deviation, median, and range values for continuous measures. For categorical variables, the number and percentage of subjects with a specific level of the variable are reported. For survival analyses, Kaplan–Meier (KM) curves were generated, yielding estimates of median survival times, along with the two-sided confidence intervals (95% CIs) and estimates of survival at specific time points.”

[CherryTree1]

Your main premise for your agreement is not true:

Only the NWBO's SEC filing on 3/31/21 finally reported reported the PFS confounding.

You should read the DCVAX unblinded journal article May 2018
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

The study’s primary endpoint is PFS, and the secondary endpoint is OS. PFS has not yet been evaluated for this publication and will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon.

PFS Confounding is clearly noted as an issue.