NorthWest Biotherapeutics Inc (NWBO)

[MarauderWarlock33]

NWBO submitted MAA on DEC 20, 2023 to meet the CHM meeting on March 14,2024,
NWBO received MAA Validation Notice on Jan 20, 2024,
The Phase I 80 day review end on April 9, 2024,
If we don't receive RFI by then, Phase II will start from April 10, 2024 since RFI is issue in between Phases,
Phase II 70 day ends on June 20, 2024.




The assessment timetable will begin after validation of the application.

iii) Assessment process and expert advice

The assessment process includes consultation with the Commission on Human Medicines (CHM) on fixed dates each month.
The submission slots will be linked to the dates of CHM meetings.
The MHRA may additionally wish to seek advice/input from therapy area experts (specialty expert groups) during the assessment process.
The phases of the assessment process

The assessment process will run in two phases totalling 150 days
There will be an intervening clock-off period between phase I and phase II, if required.
Assessment phase I

This phase will be completed 80 days after the clock starts.
Issues arising/requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted exceptionally.
Applicants may contact the assessment team for discussing issues raised in the RFI letter.
Assessment in phase-I will also address eligibility for grant of orphan status.
Assessment phase II

This will commence on receipt of the applicant’s responses fro phase I.
Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings.
Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
iv) Appealing a decision to refuse

If the MHRA proposes to refuse to grant the MA based on advice from CHM, there is an opportunity for the applicant to request a review of the decision.
The procedure for such review is set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations.
The MHRA decision letter will detail the appeal process and timelines.
The orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.

v) Publication

Conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.