I try to stay neutral and grounded and fact based so generally ignore most of the things people are saying about NWBO both long and short, because so much of it is just people in their feelings. This morning I saw for the first time someone say they think MHRA has already rejected it and NWBO is appealing the decision, which to my mind is a pretty wild thing to say. But because it's not completely impossible it made me go through my mental model of what I think is actually happening.
First off I think this idea of rejection and appeal is kind of crazy because of the April PR about the leukapheresis clinic. Putting that out while sitting on a rejection/appeal would be straight up misleading shareholders, which while definitely possible, is the kind of thing I think the SEC would actually care about a great deal. Also something that I think would leak.
Second, there are actual results out in the world. There's survival data and the toxicity profile is known. Compared to existing treatments and survival for glioblastoma, and considering that MHRA makes its decisions weighing benefit against risk, if we're looking at the medical side then in my mind there's no reason to reject DCVax.
Third, there have been statements made by MHRA recently about how they are developing new frameworks for novel treatments for incurable diseases. Those frameworks are not in place yet but rejecting DCVax -- which is just such a treatment, and one with extremely low toxicity, for just such a disease -- while saying publicly these are the kinds of treatments that should be easier to bring to market...that doesn't make any sense to me.
Fourth, NICE has an active technology appraisal open for DCVax-L right now, listed as "in progress" under ID836. This is worth paying attention to because it's not the first time NICE has opened this appraisal. Back in 2018 when NWBO couldn't provide the evidence submission NICE needed, NICE explicitly suspended the appraisal and published a notice saying so. That suspension is on the public record. Today there is no suspension notice. ID836 is still active. If MHRA had issued a rejection, I'd expect NICE to do what they did in 2018 and suspend it. They haven't.
Fifth, every once in a while people are still bringing up external control arm data in the Phase 3 trial as grounds for rejection. In May 2025 the MHRA published draft guidance explicitly welcoming external control arms for trials where a traditional randomized control arm would be unethical or unfeasible, which is glioblastoma exactly. Arguing MHRA will reject DCVax-L on ECA grounds is arguing they'll contradict their own published guidance from eight months ago.
So what's the delay about? There are operational issues that MHRA cares about and these are what I think is the cause. Can NWBO deliver the same treatment as in the trials, safely and at scale? These are things that need to be worked through and I would imagine take a long time, potentially requiring actual changes in manufacturing, delivery, storage, and administration processes, all of which could take weeks or months to resolve.
On the manufacturing question, I think there's one and only one existing example of a commercially available personalized immunotherapy: Provenge. It had enough similarities with DCVax that it can serve as a sort of template for regulators, but DCVax is more complex which makes manufacturing validation harder and leaves more for MHRA to work through. Also, Provenge ultimately was not successful in the market and the maker went out of business. But those commercialization issues are NICE's to work through, not MHRA's. And there's enough examples of MHRA appproval and NICE rejection that I think there's no chance MHRA is sitting on anything because of commercialization.
Anyway, that's my thinking. Good luck to anyone invested. Hopefully MHRA approves soon and this ground breaking treatment can be brought to market.
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