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Re: ae kusterer post# 360650

Tuesday, 03/09/2021 1:31:44 PM

Tuesday, March 09, 2021 1:31:44 PM

Post# of 701935
Yes, Advent has a Special Programs license from the MHRA to manufacture DCVax-L on a Compassionate Use basis. All of the DCVax-L vaccines must be manufactured in compliance with GMP.

However, I don’t believe Advent has been GMP licensed for commercial production yet. I believe part of the delay is due to COVID-19 causing some delays in MHRA doing onsite inspections throughout the UK. Also, Advent is trying to finish the build-out & hiring all the employees needed for commercial GMP licensing.
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