Replies to post #659395 on NorthWest Biotherapeutics Inc (NWBO)

[bidmark]

Is Boxing Day considered a holiday or a business day?

[flipper44]

(Quote below originally posted by DennisDave). In this case, “received” seems to be synonymous with “validated.” NWBO should potentially be the first to experience MHRA’s new efforts. (Aka: First Chair)

This week, Will Quince, a minister of state in the ruling Conservative Party, outlined the steps MHRA is taking to reduce turnaround time and set a target for how long it will take the agency to consistently meet the truncated timeline.

“MHRA is proactively engaging with the relevant Trade Associations on how best to improve the quality of marketing authorization applications, including workshops to support companies.

With the measures put in place, the MHRA anticipates that all priority and good quality dossiers that are compliant with legislative data requirements received from 1 January 2024 will be progressed within 150 days,” he said. MHRA’s guidance on 150-day reviews applies to all high-quality applications. As such, the guidance and Quince’s comment suggest that applications that cover all the required common technical modules and other information requested by MHRA will benefit from an accelerated review.

https://www.raps.org/News-and-Articles/News-Articles/2023/6/Euro-Roundup-MHRA-targets-150-day-turn-for-priorit

[NotSure2]

A more realistic timeline for MAA acceptance (if accepted) would be more towards the week of:
15-19 Jan (more likely)
8-12 Jan (if we are lucky)
22-26 Jan (2nd most likely)

(moved these to the right by 2 weeks if the graph mean "business days" instead of net/overall/calendar days, which would mean 22-26 Jan (if we lucky), 29 Jan- 2nd Feb (more likely), 5-9 Feb (2nd more likely).

Based on Hoff own graph.
Look at the average days in Dec 2022, not Nov 2023...

-Governement agency, lots of key people use Christmas/New years leave. This is why you see such a spike on applications made late in December/January. And the small backlog (longer processing time Feb-March) following these key personnel taking leave. Not much work will be done before the 8 Jan. (governement agency, remember)

-Add to this the size of the application itself, novel drug, complex, look more at the longer time average as oppose to the quickest time average.