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Re: flipper44 post# 568669

Friday, 02/17/2023 9:08:59 AM

Friday, February 17, 2023 9:08:59 AM

Post# of 693130
For me the paragraph makes perfect sense and it is just the bears trying to sow confusion by making statements that state that Advent is getting a general style license to manufacture any biologic type product which is really just smoke and mirrors. The MHRA are approving Advent's ability to manufacture at scale a specific product in this case DCVAX-L which depending on the type of manufacture clean rooms or EDEN unit needs to follow a specific process. It is clear that MHRA need this product to be at least under review for approval because without this what would they be testing a facility on with regards commercial approval. For a company to achieve Product License (MAA) they need to have the process of manufacture approved first via an MIA so this tells me that the MAA has already been submitted and is under review otherwise the MHRA would not have even started the process of MIA for commercial license.
It is obvious to me that the final submitted MAA contains the full manufacturing process of any given product that the MHRA needs in order to grant an MIA. All IMHO.
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