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Re: Red_Right_Hand post# 690416

Friday, 05/10/2024 5:45:37 PM

Friday, May 10, 2024 5:45:37 PM

Post# of 693776

MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.



So when does the 150 day clock start? Is the Jan 24 or Mar 7date the 80 day period for the RFI?
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