NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

That’s incorrect BrightBoy. “Days To Acceptance” has everything to do with when the MHRA’s 150-day-assessment clock will actually start on Northwest Bio’s marketing application. And “what this has to do with approval,” is to attempt to more closely predict the approximate timing of the approval.

The MHRA’s assessment (and clock) does not start until the application has been validated. Regulatory Agencies first perform a technical validation of the marketing application to ensure that all of the essential elements that are required for scientific assessments are included, and that these elements are all organized and located according to the standard electronic Common Technical Document (eCTD) format. While it is true that the marketing application has been submitted by Northwest Bio, and received by the MHRA, it has not been “officially accepted” yet. And by the way, no they don’t “hand it back to the company” or “throw it in the trash” (it’s digital) but if the MHRA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a certain deadline.

150-day assessment for national applications for medicines

Validation
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

New active substances and biosimilar products
You should submit a valid, full application for evaluation. The accompanying cover letter should detail the intention to seek orphan status or MA under exceptional circumstances as applicable.

A valid application/dossier should include common technical modules (CTD modules 2-5) and a UK specific CTD module 1, consisting of an appropriate Risk Management Plan (RMP), UK PIP CC and/or compliance with UK Orphan Medicines requirements, when applicable.

The SmPC/PIL may be submitted as Word documents in the working documents folder. There is an option to put the UK specific SmPC PIL/Labelling text/mock-ups in the UK specific folder which is available within the eCTD structure.

Applications that refer to an ASMF should ensure that the file (including the restricted part) has already been submitted to MHRA and a suitable letter of access authorising MHRA to make reference to the confidential information in the restricted part of the ASMF should be provided.

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines