We can throw the timelines out the window on this one. I believe the MHRA is asking questions and NWBO is providing answers just how GZ said. The package is close to 1.7 million pages. Just because the MHRA gets to day 210, they won't stop reviewing until they are satisfied with the application. No decision on this MAA also doesn't equate to a backlog. If the MHRA is able to process new applications and no applications are waiting to actively be reviewed, then they are not in a backlog. The fact that an application is taking longer than standard timelines does not put the MHRA in a backlog. It's speaks to the complexity of the application.
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