NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The ruling was released March 31st, 2017. The interim analysis happened after that. The ruling said they were not unblinded and that they only did a safety analysis up to that point, but even if they had done anything else, they would not have been unblinded. This has been put down in detail, with dates FOR YOU, countless times. Going back and listing it as 2014, and then subsequent years... that's a new trick.

I have posted this link, in response to your posts saying the same false information, other than now putting in years previous and implying that things happened after the ruling, countless times now.

https://casetext.com/case/lerner-v-nw-biotherapeutics


Opinion, Judge George J. Hazel, US District Court of Maryland, Southern Division, Motion to Dismiss, Granted -

“Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself. A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data.”

"The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded.""

The interim analysis link is below, signed by virtually all the researchers at all the research hospitals involved...they sure said blinded a lot... I did not even quote them all...

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

Published: 29 May 2018

In this report, we describe the blinded interim data of the overall ITT patient population enrolled in a Phase 3 randomized, double-blinded, placebo-controlled clinical trial of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) for newly diagnosed glioblastoma. To date, we have not yet reached sufficient events (i.e., deaths) in this trial to justify unblinding. Nevertheless, since the vast majority (86.4%) of the ITT population received the experimental DC treatment at some point during the trial because of the cross-over study design, analysis of the interim data may provide early insight into the impact of DCVax-L on overall survival. A final analysis of the data obtained in this trial following unblinding will occur once sufficient events of disease progression or death have occurred to fully elucidate patient survival data in the tail of the survival curve.

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.

Safety and toxicity
Safety and toxicity data were assessed on a blinded basis for all 331 ITT patients. Following SOC chemoradiotherapy, and before any DCVax-L treatment, lymphopenia was the most common adverse event, occurring in approximately 170 patients (51%) [23].

Discussion
Although enrollment was completed in 2015, this trial, including both treatments and follow-up, is still ongoing and will remain blinded until sufficient events of disease progression and/or death have occurred to more fully elucidate the tail of the survival curve. To date, due to the crossover design, nearly 90% of the ITT population received DCVax-L at some point in the trial, due to the crossover design.

Beneficial effects of immune therapies are often observed at later time points, in the tail of the survival curve [26]. Although this Phase 3 trial requires further maturation, a picture is beginning to emerge from the blinded interim data which is consistent with an extended survival tail. For example, among the patients (n?=?182) who were?=?36 months past their surgery date as of the date of this analysis, 24.2% (n?=?44) were alive for?=?36 months and have a KM estimated median survival time of 88.2 months. Thus, it appears that patients who survive past certain threshold time points may continue onwards to unusually long survival times, similar to the findings in our prior Phase I/II studies of this DC-based vaccine [17,18,19]. Further maturation of the trial data is needed to more fully reveal the extent of the long tail of the survival curve.

Funding
Northwest Biotherapeutics, Inc. was the trial sponsor and had a role in the design and conduct of the study, along with academic advisers; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Data collected by the CRO from the investigators and their site personnel were analyzed and interpreted on a blinded basis by senior academic authors, independent statisticians, and representatives of the sponsor.