Once the draft SmPC is issued by MHRA, NICE can accept the submission. If NWBO has not submitted to NICE as of July 15, then logically, they had not yet received the draft.
Still refusing to acknowledge the indisputable FACT that you are wrong about the "draft"?
The draft is done, Slave. NWBO doesn't receive the draft, they generate it and give it to the MHRA. The MHRA reviews the draft and deploys the final label at the end of the process. The draft, which NWBO already has AS A MATTER OF FACT because they are the ones that made it as part of the required package for submitting an MAA, is already complete, in hand and ready to submit to NICE.
Why the draft, along with the entire evidence package, hasn't been submitted to NICE is the real mystery. But it has nothing to with the MHRA being in the labeling phase and NWBO waiting on a draft label which, again, is a regulatory impossibility.
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