NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

hyperopia
612791

flipper, I’m pretty sure the 1.7M pages is for a single marketing application. I wouldn’t get too hung up on Linda’s discussion at the ASM of the 1M page count, or the fact that it increased, since it was still a work in progress, and she seemed to be talking in general about this.

I’ve talked to an associate who has submitted many applications, who said he wouldn’t be surprised if an application for a novel cell therapy product like DCVax, that has been through a phase III trial with several hundred patients, and many years of manufacturing development, contained 2M pages. I think the page count went up considerably, when the manufacturing data that Advent was tasked with, was added sometime this spring. Just to give you an idea of all the required data, this is some of the FDA guidance for the application:

Guidance for Industry M4E: The CTD — Efficacy

https://www.fda.gov/media/71610/download

M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf