NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The thing speaks for itself, but here, below,is the process for established medicines. As you can see, “technical” validity is determined immediately. Or as close to submission as possible, that is not “Phase I” as you claimed in your last quote I gave. Next, the initial assessment is made, which includes “scientific assessment,” (not in phase ii as you claim). In other words, you were wrong. They do make a scientific assessment, and if no issues are raised, it goes straight to a “determination.” If a request for more information is instead issued, the clock goes off for 60 days. The second assessment begins from receipt of the response. If it is a complete response to the RFI a “determination” will be made, just like it would have been in the initial assessment if no issues had arisen.

We are taking significant steps to assess applications for medicines approvals within statutory timeframes. We will always prioritise applications according to public health need.

From 1 March 2024 we will be introducing a process change to ensure applications are complete on initial assessment, or as soon after submission as possible.

Upon receipt of an application MHRA will check documentation provided for technical completeness. If applications are incomplete, they will be refused
Applications which are technically complete will continue on to scientific assessment and where there are issues raised a single request for information (RFI) will be sent out to the applicant (there will no longer be more than one RFI).
Applicants will have 60 calendar days to respond to the RFI.
There will be three outcomes from this point:
If the response is complete the application will be determined
If the response is inadequate on quality, safety or efficacy grounds, then the application will be referred to the Commission for Human Medicines for advice
If no response is received within the timeline of 60 days, then the application will be refused.

. https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines#established-medicines