Replies to post #597725 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Kool.

So they have teams working on the pre-requisites.

The Company is working with teams of specialized consultants on pre-requisites for the application, and on portions of the application package itself.

Same could be true for a company launching a P3 trial.

[learningcurve2020]

They're paying lots of consultants and thinking about "prerequisites" is where they are. Probably converting the ever illusive Master File from a Zip is creating issues too. Oh, and don't forget "Covid is still out there." Eye rolls.


>>The Company is now working on preparations for an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on pre-requisites for the application, and on portions of the application package itself. One of the pre-requisites - obtaining regulatory approval of a Pediatric Investigation Plan (PIP) - was completed during 2022 on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial.

Additionally, substantial progress was made with the CRO and specialized consultants on preparing the Trial Master File to be inspection-ready for regulators.