In that response, NICE confirmed that NWBO was still engaged in the MAA process and not yet in a position to submit their evidence. That statement implies the company had not yet received its draft SmPC, which under NICE PMG24 is a required component of submission.
The draft SmPC only becomes available after MHRA completes its internal review and enters the labeling phase. So it’s reasonable to infer that the labeling phase began shortly after July 15, likely between July 16 and July 20.
Oh my gosh you literally have no idea how this process works.
The draft SmPC is done. The draft SmPC is a requirement to submit the MAA - it is part of that package. The draft SmPC was done no later than December of 2023.
Market Data 
Markets 
AI
