NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Here is what I think has happened so far. IMO.

1. December 20, 2023 NWBO submitted the MAA.

2. January 24, 2024 MHRA validated MAA at 34 days (aka: 4 days later than MHRA’s target)

3. March 7, 2024 above validation confirmed.

4. Sometime approximately between April 10 and May 10, MHRA started actually reviewing NWBO’s submission. They should have started January 25, but their backlog and workload put them about 80 days to possibly 110 days behind.

5. LP, imo, was told the 80 day review started late, so she scheduled an ASM for June 29, 2024 to say what she could say prior to receiving an RFI. IMO.

6. Sometime between around July 1 to August 1, imo, NWBO received an expected (80 day worked) RFI. (MHRA about three to four months late)

7. Sometime between around September 1 and October 1, NWBO responded (within 60 days of RFI) imho.

8. It’s conceivable that even by October 1, the 150 day accelerated schedule was in tact but for the initial delay. Meaning only 80 days clock on by somewhere between around Sept 1 to October 1.

9. Personally, due to the most recent 10Q, I think NWBO got its response in before September 30.

10. In which case, if we take September 10 as the approximate date NWBO submitted its 60 day response, that means MHRA would have 70 days from there to complete its 70 day 2nd review phase.

11. That would be around November 20. So MHRA inspections could be behind a bit (from the time RFI was likely issued), but it is conceivable inspections were started before NWBO returned its 60 day submission. In which case, that could have been October 1, which would put the 70 day review due by approximately December 10.

12. So either, imo, MHRA is still not late if you allow them that full initial backlog start date buffer, or they are possibly running about a month behind since the (likely) RFI was issued.

13. I know it’s hard to think 150 days might still be in tact, or perhaps at most, thirty days behind by December 10 (if you take into account the initial delay), but what MHRA has done to clear its pre 2024 MAA national backlog is nothing short of amazing.

14. All those resources start funneling forward toward reviews like NEW national MHRA reviews, so it is not naive to hope they complete our DCVax-l review before 2025.