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Re: DocLee post# 710467

Monday, 08/05/2024 2:43:39 PM

Monday, August 05, 2024 2:43:39 PM

Post# of 723909
DocLee, MHRA is almost certainly conducting inspections in the US for our MAA in the UK because the vast majority of the trial sites for DCVax-L were in the US.
However, I believe the FDA will appreciate any observations and conclusions that the MHRA draws from their inspections when they are ready to evaluate DCVax-L for approval here. As we all know, the MHRA is building close relationships with many countries around the world, including the US, through agreements to share data on new drug trials and MA applications , all so that we can get successful new drugs to market faster.
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