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Re: Slave1 post# 776426

Thursday, 07/17/2025 10:08:36 AM

Thursday, July 17, 2025 10:08:36 AM

Post# of 822828

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?
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