$NWBO
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After more than 2.5 years in the MHRA process, the question is no longer whether a decision should be made on DCVax-L — the question is why a decision still has not been made.
At this point, I cannot help but wonder whether powerful interests are benefiting from continued delay. Every month that passes forces Northwest Biotherapeutics to raise additional capital, diluting shareholders and weakening the company financially. Whether intentional or not, the effect is the same.
It is also impossible to ignore the broader context. Northwest Biotherapeutics is currently pursuing litigation in the United States against several major market makers, alleging manipulative trading practices, including spoofing. These are some of the most powerful participants in the global financial system.
While I have no evidence that any regulatory body has been improperly influenced, it is fair to ask difficult questions when a company involved in such litigation experiences extraordinary delays. Large financial institutions often possess extensive networks of influence throughout the financial ecosystem. It is therefore reasonable for investors to question whether forces that benefit from delay may also be working, directly or indirectly, to prolong uncertainty surrounding this application.
The UK has repeatedly stated its ambition to become a global leader in cell and gene therapies. If that is truly the goal, this case sends exactly the wrong message to investors around the world.
Capital is the lifeblood of medical innovation. Investors fund the research, the clinical trials, the manufacturing infrastructure, and ultimately the therapies that patients desperately need. When a promising therapy remains in regulatory limbo for years, confidence in the system is damaged.
DCVax-L has demonstrated long-term survival benefits in glioblastoma, one of the deadliest forms of cancer. Approximately 13.5% of patients were alive at five years versus roughly 5% under standard care, with a long-tail survival benefit and minimal toxicity.
Meanwhile, patients continue to wait.
Investors continue to wait.
Doctors continue to wait.
The scientific community continues to wait.
Regardless of the final outcome, the MHRA owes patients, physicians, researchers, investors, and the public a clear and timely decision.
If the UK wishes to remain a destination for biotechnology investment and a leader in advanced therapies, transparency, predictability, and timely regulatory action are essential.
Two and a half years is enough.
politics.co.uk/mp-comment/20…