Replies to post #793505 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

https://pharmaceutical-journal.com/article/news/medicines-regulator-eliminates-100-day-medicines-approvals-backlog
Looks like backlogs mean cases that haven't been resolved.

"We need to maintain this going forward and ensure there is no return of delays. We also need to ensure there is an acceleration in approvals back to around 12 to 15 months for new generic medicines."

[manibiotech]

MHRA is full of s.... they always have plausible deniability . If your personal enterprise depends on their public execution , then you asked for trouble yourself 

[dennisdave]

“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

[Steady_T]

If MHRA can use a mechanism to stop the clock then the delay doesn't count against the 210 day time clock.
MHRA has several methods to stop the clock and standard 2 clock stop periods are just one of the methods.

They can ask CHM for advice on an issues the MHRA doesn't have the expertise on, or to consult with other UK governmental agencies.
Given the recent policy changes that would seem a likely clock stop. The MHRA can also clock stop to consult with third parties and other governments.

NWBO has indicated that it has received a stream of questions from MHRA, each of those could stop the clock while NWBO prepares a response.