I believe it has recently become very clear to most longs at least, that the main reason the NWBO MAA is taking so long is because regulators (and perhaps the company) were waiting for the MHRA's new regs that created a framework to approve new ATMP medicines and de-centralized manufacturing (such as Flaskworks' EDEN). And YES, of course, they needed EDEN up and running.
We were all told that DCVax-L would begin commercial production using the Artisan method, followed by EDEN when the demand for DCVax-L grew. Most of us believed this right through the beginning of this year and beyond. I believed it right up until the NHS, a health agency I didn't even know had a say in this process, added DCVax-L to the high-cost list of UK drugs to be paid for by the government for UK citizens, on a case-by-case basis, through the IFR (Individual funding request) program.
Yes, this was an approval of DCVa-L, of sorts. A bridge until the regulations supporting our MAA approval was itself approved, And a clue that full approval would take a little bit longer.
It was at that point (I think it was May) that I began thinking we would be waiting for a little bit longer for full approval because there was something else we needed. Now that the regs are in place, that something else, IMO, is EDEN, set up, validated, and ready to take on thousands, not just 500 or a thousand, patient vaccines a year.
Why do I believe MHRA decided to wait for the new regulations and for EDEN? Because they've seen the demand for DCVax-L escalate during the last year !
How can they confirm the increase in demand:
1) The company has had 3 years of compassionate care through the specials project to confirm how well DCVax-L works not only for GBM, but also for other cancers and other gliomas. We know patients with other cancers have been treated because Dr. Bosch (and/or Dr. Liau) talked about it during a presentation, stating their were 10s of patients in other cancers that received DCVax with or without adjuvants, and hundreds of brain cancer patients.
2) UCLA and perhaps other universities (Mayo maybe?) have run clinical tests that show how well DCVax-L works with adjuvants, such as Poly-ICLC. We know the UCLA clinical tests with Poly-ICLC and Keytruda produced astounding results, even though the number of patients is small, for a cancer so deadly.
3) We know personally of patients who have done remarkably well on DCVax-L plus various adjuvants who were in the specials program or one of the trials. Their stories have been shared on iHub or on a stage at ASCO.
4) We know that MHRA was impressed enough with the results coming from the Compassionate Care program to approve expansion for the program into cancers beyond GBM. This was stated in the Management section of the recent SEC filings. Management talked about what was being done to make this expansion happen in the coming year(s).
5) We have seen the requests on the Go Fund Me site from cancer patients asking for help to fund DCVax-L as their treatment and some of us have even contributed to them.
6) We've seen the push from experts, doctors, cancer organizations, and even Parliament to please get DCVax-L approved as soon as possible.
7) We've read the comments from management saying that they are receiving many requests for DCVax-L to treat GBM (and other cancers!)
So, is there any doubt that by the time our MAA reached the desk of an MHRA official the need to hit the ground running with EDEN approved for DCVax-L is now, not a year or two from now?
So why haven't we been approved yet?
I believe that by 2024 both MHRA and the company thought they could ramp up gradually over the next year or two. But something changed that summer/fall. Our first clue was when the number of pages in the MAA jumped from a million to 1.7 million. I believe even back then the company and the regulators suspected they were facing a mountain of pressure to make DCVax-L available to everyone in the UK. And the evidence was in those additional page.
But how to do it?
The company ultimately only asked for what they originally wanted: nGBM and rGBM. But they already knew or suspected that Phase III glioma should also be included in the package. And if MHRA officials didn't know it, they probably did after reading our MAA.
The big question: do they rush and serve only 500 to 1000 UK patients for GBM? Or do they push through the regulation changes so that DCVax-L could be legally approved, knowing that EDEN was close to approval, too?
In the end, they appear to have gone with the second option. They knew it would upset investors and patients already suffering from cancers, but in the end it would save both MHRA and the company time and money, and probably save more lives because more patients could be served. In the meantime, they put in force the IFR program to help the neediest patients.
The bottom line is we don't know when we'll get approval, but we do know that everything is moving forward. Almost every week we hear of another issue resolved; this week the new regs became law Wednesday for a quick ramping up of commercialization with EDEN units, as soon as the type C-cleanroom is completed. That 's the latest news. This option saves months, maybe a year or more of waiting for expanding commercialization applications to be approved one by one.
I hate to have to say it's worth the wait, but deep down I think longs all know that's true.
In the meantime, it's nice to think that MHRA may be able to push and wedge this treatment into their 150- or 210-day approval window, but I think that's an unnecessary, but interesting exercise to play around with while we wait. I think we are well beyond counting on days and off days to make our MAA fit the plan.
However, I also believe we don't have to wait too much longer.
I believe they made the right choice.
And when the approval comes, well, better make sure you're belted in and ready for the ride. This is going to be an interesting year. IMO
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