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Re: timung post# 588486

Tuesday, 04/25/2023 8:53:49 AM

Tuesday, April 25, 2023 8:53:49 AM

Post# of 698578
MHRA already read it during rolling review of separate components. The final submission includes components already reviewed, and in NWBO’s case, this likely already entails all manufacturing requirements.

From time of MAA submission, an approval (or not) decision takes 80 days or less in 97% of cases.
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