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Re: Smitty5150 post# 607966

Sunday, 07/09/2023 7:00:15 AM

Sunday, July 09, 2023 7:00:15 AM

Post# of 732007

July 8
“Application has been submitted for at least 30 days”- scotty


So final submission around June 1.(scotty)
The guidance recommends a pre-submission meeting with the MHRA approximately 90 days before the final submission.
June 1 – 90 days= March 1
On March 20, 2023 Northwest Biotherapeutics and Advent BioServices announce receipt of License for Commercial Manufacturing at Sawston, U.K. Facility.
I don't think you plan a meeting with the MHRA (around March 1) if you don't have the necessary licenses.
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