NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

NotSure2, I don’t agree with your timeline or “analysis.” I think there are many reasons to believe, (and I’m on record as saying) that it’s very likely that Northwest Bio is in the “rolling review” process. So I think once the application is accepted, it will be approved within the 100-day review timeframe. I understand that it could take up to 150 days with the clock-off period, but it appears to me that Northwest Bio is taking the time on the front end, and filing a very complete application, to ensure that there won’t be “requests for further information” so the application can be approved more rapidly.

United Kingdom
The UK national regulator Medicines and Healthcare products Regulatory Agency (MHRA) has implemented a rolling review process as part of its national applications following Brexit.3 This process can be used for any MAA for new active substances, including biologics. Applications for biosimilars are also eligible under this route.
Developers wishing to enter the rolling review should request a pre-submission meeting with the MHRA to discuss the product, its intended target populations and the data in each module to be submitted. Companies should specify if the future MAA is intended for the UK, Great Britain (England, Scotland and Wales) only, or Northern Ireland only.

The quality, nonclinical and clinical data may be submitted separately or jointly, depending on the specific development pathway and/or availability of data. Submission should be in the CTD format (modules 3–5, as appropriate). The assessment cycle for each submitted module will be completed within 60 days. Following each assessment cycle, a module assessment summary (MAS) will be issued by Day 60. The MAS will offer the applicant opportunities to update the module where required or to provide additional information where needed. The pre-assessment process may also include consultation with the Commission on Human Medicines (CHM) and/or therapy area experts (specialty expert groups).

It is recommended to have a pre-submission meeting with the MHRA around 90 days in advance of the intended submission of the final phase of the MAA. The UK paediatric investigation plan (PIP) compliance check (CC) should be performed 60 days before the submission. The final application/dossier should include submission of any unassessed modules or data, which may include the clinical module, UK-specific CTD module 1, consisting of an appropriate risk management plan (RMP), UK CC and/or orphan designation application (if 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 eCTD folder structure. Once the MAA is validated, the assessment clock starts, and the final phase should be completed within 100 days in two stages as 60 + 40 days with an intervening clock off period. A request for further information (RFI) may be issued by Day 60 and the applicants may discuss issues with the MHRA within 30 days. The clock resumes on Day 61 when the RFI response is received by the MHRA, and the CHM will be consulted, with the final decision on approvability reached by Day 100. If applicable, orphan status will be determined at the time of grant of the MA, after which refund of any relevant application fees (eg, scientific advice, MAA) may be claimed by the MA holder.

https://www.vennlifesciences.com/wp-content/uploads/2021/04/Speder-Bruno-Rolling-Reviews-Feature-May-2021.pdf