NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Right, it should be readily apparent that yesterday’s MHRA announcement doesn’t apply to, or really help Northwest Bio. The first clue is right there at the top, “Details of the process changes for Established Medicines, effective from 1 March 2024, which apply specifically to ‘chemical’ products.” So it would not apply to Advanced Therapy Products.

Secondly, an “established medicine” means one that has already received a marketing authorization and is licensed. Therefore, when a new marketing authorization for an “established medicine” is requested by the license holder, say to treat a new therapeutic indication for example, only a variation to the original marketing authorization is required. Since some assessment criteria has already been previously “established,” and known to the MHRA, the application can be processed more “swiftly.” So once DCVax is approved in Glioblastoma, the approval process to extend the label for other indications, is more rapid.

Although the MHRA is familiar with DCVax, and Northwest Bio has likely previously submitted an Active Substance Master File (ASMF) and Summary of Product Characteristics (SPC) for compassionate use approval, for the purposes of the MAA, DCVax is still considered a new active substance, and will require a full assessment. This is evidenced by the fact that Northwest Bio requested the 150-day route, and not a variation.

It seems to me the MHRA is making a concerted effort to improve their assessment timelines and looked at the easiest areas to improve first, which was with the International Recognition Procedures for medicines that are already approved by other regulators, where only limited assessment by the MHRA is necessary. That was put into effect by the beginning of the year, and now, the MHRA is working on “established medicines” that have already been approved, and also don’t require a full assessment.

As far as the changes about the RFI; what I get from reading that, is that apparently a number of applications are not fully complete, or are lacking some information that is necessary for a complete assessment, and the MHRA does not want to keep making requests for more information if the answers to their RFI are still incomplete. So it seems that in some cases, the applicant, rather than the MHRA, may be partly responsible for extending the MHRA’s timelines, and that change is another way for the MHRA to meet their targets.

I think the fact that Northwest Bio preemptively spent a couple extra months on the front end improving the application, prior to submission, makes it more likely that their application is complete and “high quality,” and therefore will not require the MHRA to issue a RFI. To me that, and the continual progress and concrete steps being taken by the MHRA to improve their timelines, may make it more likely that Northwest Bio’s application will receive an opinion within the established 150-day from submission timeline, rather than 210 days that I previously thought.