Replies to post #511970 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

You are correct. OS is the gold standard.

The endpoints and study design have been approved by regulators. The approval was recently reaffirmed as legitimate and clinically appropriate:

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

[HyGro]

But yet there are many reasons to question the legitimacy of manipulated trial outcomes.