That’s a fair interpretation, but it’s also entirely possible the long MHRA review period is because NWBO and Advent wanted Eden folded into the licence before approval, rather than added later as a post-approval variation.
Under MHRA’s modular manufacturing regulations (SI 2025/87), a new digital or automated system like Eden can be included in the same marketing authorisation if validation and comparability data are ready before the licence decision. If that’s the route they chose, it would naturally make the review take longer, MHRA would be assessing both the product and the automated system at the same time.
The February 2024 press release confirmed the Eden GMP units were only then entering final qualification and validation, so 2024 through mid-2025 would have been spent completing those steps and generating the comparability data MHRA needs. If that data package was added to the existing submission this year, MHRA’s review would have expanded to cover both the manual and Eden manufacturing pathways.
So, two possibilities exist:
1. Eden is being folded into the current approval, which would explain the extended timeline and would allow immediate automated manufacturing once the licence is granted.
2. Eden will follow after approval, in which case DCVax-L launches first under the manual process, and Eden is added at the next GMP inspection in 2026.
Either outcome is acceptable. The first explains why approval has taken longer; the second simply means Eden comes online a few months later.
In short, the wait could be because MHRA is reviewing Eden as part of the same licence, and that would actually be a positive, forward-looking move by NWBO.
Bullish
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