NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

Here's exactly when DCVax-L will be approved, based on available data.

Hope, your question made me look into not just this case but other recent submissions/approvals to try to see if there was anything to be learned.

TL;DR: Based on CHM meeting minutes, MHRA performance reports, and public reports on MAA submissions/approvals, DCVax-L will be approved between 11/14/24 and 1/31/25. Here's why:

I spent some time looking at CHM meeting minutes, MHRA performance reports, and public reporting on submissions and approvals, and came to few conclusions.

1. Medicines are often reviewed at two CHM meetings, six months apart
For new MAAs where sufficient information was available, two CHM meetings took place six months apart from one another. See Ritlecitinib, which was addressed at the 1/26/23 meeting (note: when meetings take place across 2 days, I just list the first day) and again at the 7/27/23; or Exagamglogene Autotemcel, which was addressed at the 4/27/23 meeting and again at the 10/26/23 meeting.

2. The first meeting is scheduled based on when the MAA was validated
Exagamglogene Autotemcel was validated on 1/27/23, and the first meeting occurred on 4/27/23. The deadline for this meeting was 1/30/23. This coheres with Lecanemab, which was submitted on 5/21/23. I don't know when it was validated, but if happened on a similar timeline to DCVax-L (about 1 month), that would be consistent with making the 7/3/23 deadline for the 9/28/23 meeting, where it first appeared.

3. New MAAs can be approved anywhere from 3 weeks to 6 months after their second CHM meeting
Based on the available information, Exagamglogene Autotemcel was fastest; it was approved on 11/16/23, 3 weeks after its second meeting on 10/26/23. Vadadustat was also approved quickly, approved on 5/22/23 after a CHM meeting on 4/27/23.

On the other end of the spectrum, medicines like Ritlecitinib (7/27/23 meeting prior to 11/1/23 approval; roughly 3 months) and Opdualag (6/29/23 meeting prior to 12/27/23 approval; roughly 6 months) took longer.

We can also extrapolate a longer time frame for Alzheimer's treatments Lecanemab (first meeting occurred on 9/28/23; second meeting likely occurred 3/21/24 (minutes not yet published); approval occurred on 8/22/24, 5 months after the second meeting) and Donanemab (first meeting occurred 11/23/23; second meeting likely occurred 5/30/24 (minutes not yet published); approval occurred on 10/23/24, 5 months after the second meeting). (Note: another poster implied that Donanemab's MAA was submitted after and approved before DCVax-L's. This seems unlikely; I couldn't find an exact submission date, but no mention of submission was made when results were announced in July 2023, and it had apparently been submitted by 12/17/23. A July/August 2023 submission/validation seems most likely; that would be 2 months after Lecanemab, which would make sense given that Donanemab's first CHM meeting and approval were both also 2 months after Lecanemab.)

4. MHRA is on pace to clear its backlog by the end of January 2025
Approvals up to 6 months after the second CHM meeting doesn't sound too good, but remember that the MHRA started this year with a massive backlog of work, which it has been annihilating over the course of the year. Monthly performance reports show that as of the beginning of October it has eliminated 70% of its backlog, and is on pace to clear it completely before the end of January. Here's a graphic showing the trend over the course of this year.

5. Implications for DCVax-L
So, what does it mean for DCVax-L? DCVax-L's MAA was validated on 1/24/24. That means that it made the 1/29/24 deadline for the 4/25/24 CHM meeting; if that was the case, then its second CHM meeting would be taking place today (or tomorrow).

Based on recent MHRA performance, that would imply approval as early as 3 weeks from now: 11/14/24. Based on MHRA's performance over the past year, its backlog should be gone before the end of January, meaning that DCVAX-L's approval should come before that time. That's the basis for this prediction: DCVax-L approval between 11/14/24 and 1/31/25.