NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Next steps with the MHRA:

1. Validation of the MAA
2. Assessment of the MAA

How long does each step take?

1. Validation - 4 days (mean) to 7 days (90%)
2. Assessment - trailing 12 month averages are largely below 150 days*

* Keep in mind this data includes review processes which are not accelerated. NWBO requested an accelerated review. Also, on the 2023 chart look at the dotted blue line (it's a very busy chart). Lastly, the 2023 chart excludes Orbis and Access Consortium. If you add those back in it actually increases the approval timeline.

Data:

➡️Mean Processing Time for Acceptance of MAA⬅️$NWBO

MHRA MAA Acceptance Times

✅Mean = 4 days
✅90th percentile = 7 days
✅NWBO's MAA filed 12-20

4 (business) days = December 27th
7 (business) days = January 2nd

^^ Business days excluding Christmas/New Years

Expected… pic.twitter.com/CjkwHGZ1aK

— hoffmann6383 (@hoffmann6383) December 26, 2023

➡️MHRA Validation & Approval Timelines⬅️$NWBO

Validation Timeline:
See Prior Post. 4 days (mean) to 7 days (90%).

Approval Timeline:

2020 Time to Complete Assessment, New Marketing Authorisations - UK Only [1 & See Image 1]

2021 Time to Complete Assessment, New… https://t.co/KczzKK09i9 pic.twitter.com/x2QnYhnWlw

— hoffmann6383 (@hoffmann6383) December 26, 2023