Are you so sure “we know DCVax works”?
Supporters believe the data are strong. I understand that. But the Phase 3 results are still debated because of the endpoint change, crossover, external controls, trial design, and lack of a clean contemporaneous randomized control arm for the final OS comparison.
That is exactly why MHRA review matters.
If DCVax were already clearly established as an effective treatment, then the delay becomes very hard to explain. GBM patients are dying while this review drags on. Are we really saying MHRA has been sitting for 2.5 years plus on an obviously effective treatment while patients die?
If so, that is not a bullish argument. That would be an ethical indictment of the regulator.
And if this is now among the longest unresolved MHRA reviews, that does not make the “we know it works” claim stronger. It makes the claim harder to square with reality. A treatment that is supposedly obvious, effective, and urgently needed should not need years of regulatory silence to explain itself.
At that point, the answer has to become speculation. Maybe it is manufacturing. Maybe it is CMC. Maybe it is validation, comparability, labeling, capacity, or something else. But that is the point. The review appears more complicated than “we know it works.”
That does not mean DCVax cannot be approved. It means the certainty is overstated.
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