That language is critical. It does not suggest rejection or pause. It shows NWBO is actively working inside the MAA which places them in the final stage of the process: labeling.
There is absolutely no evidence in anything you posted that leads one to believe NWBO is in the labeling phase.
Nothing. At all.
The letter confirms that NWBO is inside the labeling phase not waiting for approval but implementing it.
No it does not. This is patently false and irresponsible.
There is absolutely nothing in this communication that has changed from the past 18 months.
The July 15 NICE letter confirms that NWBO hasn’t submitted their evidence yet, because they are still “fully occupied and engaged” in the MAA process with MHRA. That tells us exactly where they are: not waiting to apply, not paused, just actively finishing the process.
The company has been saying that they are "fully occupied and egaged" in the MAA process for the past year. Look at the 10K:
The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.
So were they in labeling back then? No.
This document is required before NICE can begin modeling value or issuing recommendations. Until the SmPC is finalized, NICE appraisal cannot start, not under path one, and not under path two.
If this document is required before NWBO can submit the evidence package (it's not, but you claim it is so we'll go with that) then again, nothing has changed. They didn't have this document a year ago, they couldn't submit then. They don't have this document now, they can't submit now.
So again, please, describe to me what has changed that proves they are now in labeling?
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