You’re misunderstanding what I’ve been saying, so let me summarize it clearly.
I never said that Flaskworks is required for MHRA approval. That’s not my point. What I’ve said is this:
Over the past two years, NWBO likely realized that manual production would not be reimbursable under NICE/MHRA economic assessments. Because of that, and for other practical reasons, NWBO appears to have voluntarily added a CMC expansion (Flaskworks/Eden) midway through the review process probably around mid-2024.
Once the sponsor voluntarily expands the CMC package, the regulator must evaluate the added data. That puts all the standard review timelines off the table. This is completely normal and has happened dozens of times in other ATMP reviews.
So the point is not “MHRA requires Flaskworks for approval.”
The point is: if NWBO adds the automation pathway during review, MHRA must respond to it, and that naturally extends the timeline. That’s the regulatory logic here
Its up to you what to believe of course.
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