NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

What the regulators are willing to buy …

NWBO has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company’s Pediatric Investigation Plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients.

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