Replies to post #511854 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

False narratives mixed with real details that are still deceptive as to impact and reality.

Do not have time to answer this nonsense for the umteenth time…

A little different focus but discusses many of the highlights and addresses the nonsense.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169821016

[Dr Bala]

This therapy will become the new SOC for the "real" non-IDH-mutant GBM. OS is great. PFS doesn't matter. The JA or the MHRA related news will be the start of the process towards approval by all the RAs.

[Roman516]

confusing the facts and confounding the thoughts but the OS data is valid and true.
NWBO will in fact move forward and prevail.

[SkyLimit2022]

That is correct —I understand what you’re trying to say and I agree—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.

The pediatric approval is full approval and immediately actionable. There is no requirement for adult approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.

https://virtualtrials.org/dcvax.cfm