NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

The MHRA have had a decade long cooperation with NWBO and DCVax-L and during this year, they’ve announced new policies, regulations, processes and more, that in themselves seems to center around cancer vaccines, faster approvals timelines for MAA application, faster approval timelines for starting clinical trials and the use of new technology equipment (ATMPs) where patients are. Point of Care.

When you look at the timeline in which these announcements fell – 100 days – and how they share a “common foundation”, it is very hard – impossible – not to see DCVax-L written all over it.

DCVax-L was the first drug in the UK to receive the Promising Innovative Medicine designation (PIM) in 2014.

DCVax-L has been available on a compassionate use basis since 2014 in the UK

In January MHRA announced

Consultation on Point of Care

New types of medicinal product, with very short shelf lives and which may be highly personalized, requiring them to be manufactured and supplied at the point of care (POC). Advanced Therapy Medicinal Products (ATMPs) like Flaskworks EDEN (my words). The fact that some products are currently in clinical trials means that the need for regulatory change in this area is current and needs to be in place to support those products as they approach application for UK marketing authorisations. This proposed framework will ensure that the UK is a favourable location to develop and trial novel medicines by supporting advancing technologies and manufacturing. manufacture advanced technology products and conduct clinical trials.

The Pathway to a Cure report was announced in Westminster February 28th. After having worked upon inquiries for over a year from patients, industry and the medical society regarding brain tumor treatments in the UK, the group delivered their recommendations to MHRA for “going forward”. In short:

Approve DCVax-L and reimburse it!

In March MHRA announced

MHRA to receive £10m from Treasure to fast-track patient access to cutting edge medical products.

MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 year.

International Recognition Procedure (IRP)

New Brain Tumour Research center for trials DIPG and Paediatric trials

The £10 funding, directly mentioning cancer vaccines, of which only one has finished a clinical trial and is ready to be fast tracked over the next two year, fits DCVax-L like a glove.

The news of streamlining of clinical trials directly mentions “make it faster and easier to gain approval and to run clinical trials in the UK” and “additional funding of £10 million for the MHRA to accelerate the delivery of cutting-edge treatments including cancer vaccines”.

The IRP news mentions “Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval)” and that “IRP can be used for biosimilar marketing authorization applications, tapping into any coming marketing approval of DCvax-L made with Flaskworks EDEN of which MHRA says “a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach” and FDA says “Biosimilars “may be approved based on PK and PD biomarker data without a comparative clinical study with efficacy endpoint(s)”.

In addition to this an article mentions the effects of the IRP, and specifically addresses that there is a fast track option for getting an MAA application approved - NOT the 150 days assessment – on terms that DCVax-L live up to.

The new brain tumor center will specifically target DIPG and paediatric trials, of which Dr. Marnix Bosch spoke of at ASCO 2019, that NWBO would be able to start immediately with DCvax-DIRECT. The center is situated within 100 miles of Advent Bioservices in Sawston.
With all the above taken into consideration, there is no doubt in my mind for the following:

MHRA has been working closely with NWBO regarding DCVax-L for a decade.

They WILL approve. NICE WILL reimburse.

NWBO has the possibility of fast tracking the MAA application. A 150 business days assessment, in average takes 80 days to approval. With fast tracking, this figure will be lowered considerable. PIP compliance check is done as well as pre-submission meeting with MHRA (NWBOs own press release words: “The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MA”), otherwise NWBO would not be able to predict 30-45 days submission.

But MHRA has been preparing for way more than this. As you can see, they’ve been announcing Point-of-Care (Flaskworks EDEN), IRP (biosimilar MAA approval, which the MHRA guidance for in 2022 tells us will probably “not be necessary”) and fast tracking approval of new trials, while preparing a new cancer center for DIPG and paediatric trials, within short of Advent Bioservices, which is what the PIP plan is all about.

I do believe in some coincidences. Here one has to be an idiot, not to acknowledge what is going on, when all the breadcrumbs for all the above has been dumped within a 100 days window.

MHRA approval is a given and unless NWBO insist on NOT GETTING fast tracked, it will happen much sooner than predicted this year.

Look at the news, the words, the message in the two images above. They tap into each other like a hand in a glove. Either the coincidence of the century or ... somebody is rolling out the red carpet.

It’s all the other stuff, that are wet dreams material.