NorthWest Biotherapeutics Inc (NWBO)

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Google AI agrees with you about the UK MHRA backlog.  :)

While the UK Medicines and Healthcare products Regulatory Agency (MHRA) has cleared its backlog for standard marketing authorization applications (MAAs), recent evidence suggests a backlog and slower review times for Advanced Therapy Medicinal Products (ATMPs). The MHRA's internal performance data and external analyses indicate that while most applications are now processed within statutory timelines, ATMPs often require more complex review, which can extend overall timelines.

Current state of the ATMP MAA backlog
General MAA backlog cleared: In March 2025, the MHRA officially confirmed it had cleared all backlogs relating to standard licence applications for both innovative and established medicines.

Persistent ATMP complexities: The review process for ATMPs is more complex due to the innovative nature of the products. This requires specialized expertise, and the volume of applications can create bottlenecks.
Extended timelines for complex applications: As of late 2024, data from the MHRA showed that while most applications were completed within target times, some more complex applications had fallen overdue. This is a potential indicator of a developing backlog for certain product types like ATMPs.

Evidence from clinical trial applications (CTAs): A related indicator of ATMP review capacity is the MHRA's performance on CTAs. While the MHRA has successfully cleared its backlog for general CTAs, the more complex review for ATMP trials can still take longer than non-ATMP trials.