NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

NWBO's MAA was not a 'backlogged' application (i.e., pending greater than 210 clock-on days) as of March 31, 2025.

-If clock started at 1/24/24 Validation, then 462 total days have passed.
-If clock started at 3/7/24 Confirmation of Validation, then 419 total days have passed.

How many of these total days could have been clock-off days, and therefore not counted against the MHRA?

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines indicates that 270 (=180+90) days are available as clock-off days (plus an additional 270 clock-off days available to be granted by MHRA under exceptional circumstances)(see quote from webpage below).

So,
-If clock started at 1/24/24 Validation, then 462 total days have passed. If 270 of these days were taken as clock-off days, then there were only 192 clock-on days as of today.
-If clock started at 3/7/24 Confirmation of Validation, then 419 total days have passed. If 270 of these days were taken as clock-off days, then there were only 149 clock-on days as of today.

Assuming that NW took all of the clock-off days available, then as of March 31st (29 days ago), NW's MAA was still under 210 clock-on days and therefore could NOT be considered a backlogged application on March 31st according to MHRAs own metrics. (And therefore was not one of the backlogged MAAs that were referenced in the 3/18/25 MHRA meeting video)

see https://www.gov.uk/guidance/national-assessment-procedure-for-medicines states:

2.3 Initial assessment phase until Day 90
...
By Day 90 (90 calendar days after the start of the procedure) we will send you the first request for information (RFI) and switch off the clock.

2.4 Responses assessment phase until Day 150

You must respond to all questions raised in the first RFI within 6 months,.... In exceptional cases, we may agree to extend the clock-stop period beyond 6 months.

If we identify minor outstanding issues, we will send you a second RFI letter by Day 150 (see section 2.5).
...
We will stop the clock when we send out a second RFI or CHM letter.

2.5 Final assessment phase after second RFI

....You must submit your complete response to the second RFI within 3 months.... In exceptional cases, we may agree to extend the clock-stop period beyond 3 months.