When NICE says NWBO is “still fully occupied and engaged in the MAA process with the MHRA” and “not yet in a position to provide their evidence submission,” that describes the labeling phase, also known as SmPC finalisation.
This exact scenario can be used to describe NWBO's status one year ago.
Fully occupied and engaged in the MAA process.
Not in a position to provide their evidence submission.
Why does that mean something different now than it did a year ago? Are you trying to imply one year ago they were either: A) Not engaged with the MHRA on the MAA? (we have quarterly reports proving that they were) or B) In a position to provide their evidence submission?
My understanding is that NICE is waiting for the SmPC and there is an in process variation due to submission of Flaskworks data then NICE is being held up by a ruling on that variation being requested and this would be happening during a clock off period. Best wishes.
“fully occupied" What does that mean ???. I think a lot of the speculation on the board could be cleared up if someone would get a clarification from the MHRA.