Appreciate the thoughtful response, Doc Logic. I agree with your core point that NICE is waiting on the SmPC. That part is confirmed directly in the July 15 letter.
Where I would offer a friendly clarification is on the idea that a formal variation request is what is holding things up. If a variation had actually been submitted and accepted by MHRA, we would expect to see a published variation assessment timeline. This is especially true for Type II variations involving manufacturing changes such as those related to Flaskworks, which fall under reportable events according to current UK transparency rules after Brexit.
Instead, NICE’s wording says that NWBO is still fully occupied and engaged in the MAA process with MHRA and not yet in a position to provide their evidence submission. That suggests they are still finalizing the core elements of the original MAA, including the SmPC, rather than waiting for a separate variation ruling.
It is certainly possible that Flaskworks data is being used to support the SmPC language or the quality section of the dossier. But if it is part of the original submission package, it would not require a formal variation. It would simply be integrated as part of the quality documentation leading into the final label.
In either case, I believe you are absolutely right that the SmPC is the gating item and that NICE is waiting for it before they can move forward. Whether the delay is due to a formal variation or the final internal steps to complete labeling, the result is the same. NICE is on standby until MHRA finalizes that documentation with NWBO.
Appreciate your thoughtful insight.
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