Monday, October 20, 2025 3:26:36 PM
“backlog” in MHRA language doesn’t mean unopened files sitting on a shelf. It refers to active reviews exceeding their target decision timeframe (usually 150–210 days for complex ATMPs under ILAP).
So yes if DCVax-L is still under review nearly two years after MAA submission, it technically counts as part of an ATMP backlog even if the file is being actively worked on. That’s exactly why optics matter here. MHRA has been publicly celebrating that they’ve cleared their ATMP backlog so carrying a high-profile case like DCVax-L into late 2025 without resolution would contradict their own performance narrative. JMO
So yes if DCVax-L is still under review nearly two years after MAA submission, it technically counts as part of an ATMP backlog even if the file is being actively worked on. That’s exactly why optics matter here. MHRA has been publicly celebrating that they’ve cleared their ATMP backlog so carrying a high-profile case like DCVax-L into late 2025 without resolution would contradict their own performance narrative. JMO
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