Replies to post #512217 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Zzzzz.

[hoffmann6383]

experts disagree with this bullshit narrative

[biosectinvestor]

You keep repeating nonsense.

No, the trial was not “manipulated” and if you are alleging fraud then surely the regulators would be first to do so. The notion that it takes you and some few other anonymous posters and Adam Feuerstein, who basically is having his sanity unwound as he tries to save face for his ridiculous behavior, is nonsense. Many of the same issues have been looked at by a federal court, and found wanting and unable to sustain even a cause of action with the most generous standard of evidence for plaintiffs, in a motion to dismiss.

The notion that there is a grand conspiracy involving federal courts, the SEC, FDA, EMA, MHRA, Canadian Regulators, UCLA, Kings College and all of the other amazing educational and research institutions involved in this trial, the NIH, various brain tumor charities, is absolutely BONKERS.

[Roman516]

The data was not manipulated as the results prove that DCVax-L works, and the OS data results stand firm.

[SkyLimit2022]

Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.

The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.

Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.

The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:

On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.

Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.

The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.

https://virtualtrials.org/dcvax.cfm

https://www.kcl.ac.uk/people/keyoumars-ashkan

https://nwbio.com/press-releases/