Hi Merlic. I agree. This news that management expects Flaskworks will begin manufacturing DCVax in the first new C-suite by Q2 (April through June) of 2026, means that if we get approval from the UK for DCVax before that, then commercialization will begin with the manual method, followed by manufacturing with EDEN in Q2 2026. If approval comes as late as Q2 next year, we begin with EDEN in place and qualified. If approval comes even later, well, we can expect NHS can issue more case-by-case approvals for our treatment, which we are paid for. Obviously, I expect the first scenario, but I have no way of knowing when approval will come, IMO, an almost certainty, with the last few PRs and Q10s, including purchase of Advent and hiring in the US.
This is great news! I can't help believing, after seeing all the cues. that management has gotten at least a wink and a nod from MHRA that approval is coming. That may be in the form of negotiations on price with NICE, for example, or negotions on how our product will be promoted.
I can see MHRA letting management know they want EDEN close to readiness before they approve, as a way of keeping cost down and as a way of addressing all of the UK's needs for DCVax-L. (Could MSRA be looking toward all brain cancers...all cancers....in the near future?)
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