Gary, I agree with you on the demand pressure point, and I actually think they will ultimately go for a tissue-agnostic label. Quite frankly, based on the trial data and the translational science, they already have enough to justify antigen-agnostic as well.
That said, the most strategic way to go about it, especially from a regulatory and market-readiness standpoint, is to start with a narrower indication like GBM. It allows the MHRA to approve within a well-defined population first, lock in manufacturing and logistics flows, and then expand under the UK’s SI 2025/87 controlled variation process as real-world data accumulates.
From a demand readiness angle, your point is spot-on: even GBM-only would be a major load on Sawston. A tissue-agnostic label from day one could create 50–100x demand relative to GBM alone, which would outstrip current capacity without Eden or additional nodes coming online. By phasing it, narrow first, then expanding, you avoid that bottleneck while still keeping the door wide open for rapid label growth once Eden or other capacity expansions are in place.
The UK’s regulatory structure makes that kind of stepwise expansion much faster than a whole new trial, so the initial scope doesn’t have to limit the long-term vision.
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