NOTBOB17 No we are dealing with the next hurdle inflicked by MHRA read SLAVES post. Makes sense:
Me thinks we are not going to see a disposition for quite a while.IMO
Slave1
Re: barnstormer post# 774244
Saturday, July 05, 2025 7:33:53 AM
Post#
774245
of 774250
Barnstormer, I really appreciate what you said. You are exactly right to bring it back to the human side. If someone you know is facing glioblastoma, or if you are, none of the bickering on this board matters. You are not worried about statistical models or process timelines. You want to know one thing: does it work, and is it safe.
With DCVax-L, we already know the answer. It has been safely used in the UK for over five years under physician-supervised conditions. It has long-term survivors. It has peer-reviewed results. The data is real. The patients are real. And the hope it brings is real.
So then comes the question: why the delay? Why has the MHRA not just approved it?
Here is the truth most of the noise on this board will not admit because they already know it undermines their narrative.
This is not delay. It is coordination.
DCVax-L does not fit the old regulatory model. It is not a pill or a monoclonal antibody. It is a living, patient-specific cell therapy. It requires decentralized manufacturing, individualized logistics, outcome tracking, and survivorship frameworks. That kind of therapy cannot just be dropped into a health system designed for static, off-the-shelf products.
So the MHRA had to build around it.
They created SI 87, a new legal pathway for advanced personalized therapies to move through the system under physician control. They restructured internally. They appointed a new chief executive who made clear that the agency’s future depends on real-world data, dynamic frameworks, and regulatory speed without compromise. They built joint coordination with NICE. They quietly aligned approvals with funding. And they supported a ten-year NHS reform plan designed to finally reward therapies based on outcomes, not just labels.
That takes time. And it has all happened within the same window that DCVax-L’s application has been under review.
Linda Powers testified before Parliament in 2022. She was not there to complain. She was there to signal what was coming. Less than a year later, the company submitted the application. And within 18 months, we have seen one of the most comprehensive structural transformations in modern UK regulatory history.
The recent guidance did not come late. It came exactly when the last piece of the system was ready to go.
So when approval comes, and it will, it will not just validate DCVax-L. It will validate the entire system built around it.
This has never been about just one drug. It is about a shift in how medicine is delivered and measured. And the UK chose to make that shift. Not with a press release. Not with fanfare. But with quiet, methodical preparation for the most important regulatory moment in years.
And when it lands, everyone will realize the long wait was not a delay. It was the cost of getting it right.
Bullish
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