NorthWest Biotherapeutics Inc (NWBO)

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I was curious exactly how long the MHRA and Northwest could possibly take before the DCVax-L application could possibly be considered "late". So looking at the MHRA link that details that entire process (shown below), I had charted out a timeline using the max amount of time that both the MHRA and NW might take to sort through the application and I'm presenting it in this post. I'd be curious to see what others think of it, or if I've missed something, so please let me know your thoughts.

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines#:~:text=The%20assessment%20of%20your%20response,150%20(see%20section%202.6).

3/7/24
Clock starts. This is what Northwest has indicated to me is the start date, so I'm going with that.

6/24/24
90 calendar days have passed. The first RFI is (theoretically) issued. Clock is (theoretically) off. Remember... these times are just following the MHRA's longest listed response times.
Note: I can't remember when the CHM noted they discussed a brain cancer treatment... someone here likely remembers that time, and it would be interesting to see how that fits into this theoretical timeline.

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. - MHRA

11/19/24
6 months is the longest Northwest would (theoretically) have to respond to the RFI.

You must respond to all questions raised in the first RFI within 6 months, but we encourage you to submit your complete responses as soon as possible. If you do not submit a complete response within 6 months, we will notify you that we propose to refuse your application. In exceptional cases, we may agree to extend the clock-stop period beyond 6 months. - MHRA

11/22/24
3 days later, the clock is turned back on.

We will restart the clock 3 calendar days after the response submission deadline. - MHRA

1/20/25
2 months later (Day 150), a 2nd RFI or a CHM letter can be issued. Clock (theoretically) goes off.

The assessment of your response to the first RFI will be completed by Day 150 (60 calendar days after the procedure restart date) and we will notify you - MHRA

4/14/25
Northwest (theoretically) is given another 3 months to respond.

You must submit your complete response to the second RFI within 3 months, but we encourage you to submit your responses as soon as possible. - MHRA

4/17/25
Again... the clock goes back on 3 days later.

6/12/25
2 months later (Day 210) MHRA can issue a third RFI. Clock is (theoretically) off.

If necessary, we will send you a third RFI to resolve any final minor outstanding issues and switch off the clock. - MHRA

9/4/25
Northwest has 3 months to respond to the 3rd RFI.

You must submit your complete response to the third RFI within 3 months. - MHRA

9/7/25
3 days later, clock is back on.

Now the decision making is back in the MHRA's hands. Up to this point, they've given themselves up to 2 months to sort through the RFI answers from the applicant. There doesn't seem to be a time frame that the MHRA is giving to render a decision, so I'm going to suggest that it's up to 2 months, which would put us at the latest... November 2, 2025.

So that's a possible scenario where MHRA and Northwest took the longest possible time to sort through the application and make a decision. If Northwest took less time to give their answers than the full time allotted them, then I would hope that Nov 2 date would move back into October.

Thoughts anyone?

:)