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Re: dennisdave post# 569143

Sunday, 02/19/2023 6:56:08 PM

Sunday, February 19, 2023 6:56:08 PM

Post# of 691849
You are joking right. No commercial license will ever be approved for a non existent biologic product. To be approved for a commercial product you have to have a product that must be in the process of marketing authorization. The MHRA rules are clear. Experimental biologic products come under completely different protocols that do not require commercial approvals. If and a big if the DCVAX-l product fails the MAA the MIA for DCVAX will be useless. This would not stop Advent from producing pre marketing experimental biologic products for clients that hope to commercialize in the future following a specific manufacturing process as designed for a specific commercially designed product.
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