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Thursday, February 29, 2024 9:19:06 AM
For the GBM MAA, the Company anticipates that the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority as well as preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information.
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
If the application is complete and without any issues that necessitate a further request for information from the MHRA after the first phase of assessment, then it means that the 60-day clock off period is not necessary, and the application has a greater chance of being assessed within the 150-day assessment period.
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