NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

I finally had some time to take a closer look at the drugs that were reviewed in the batch of CHM minutes that were released earlier this month. I noticed a few interesting things.

- There have been 6 medicines that had their first CHM meeting in H1 2024 and have already received approval. The average time from first CHM meeting to approval was roughly 6 months. (Compare this to medicines that had their first CHM meeting in 2023 or earlier, which took from 9 to 11 and as long as 13 months.)
- There are a maximum of 3 drugs still in the review process that were submitted earlier than DCVax-L. I will specify them below. There is no correlation between submission date and approval date – however, the MHRA has indicated that it reviews applications in the order they were received. So this indicates that there is no great secret backlog of NAS MAA applications "ahead of" DCVax-L. Also, note that the MHRA has been averaging between 2 and 4 NAS approvals per month over H2 2024.
- Contrary to one frequently shared opinion, DCVax-L appears to be moving faster through the process than other drugs. Information is thin on submission dates/progression through the process, but there were 2 other recent drugs where more information was available. One had to wait 12 months from submission to first CHM meeting, while the other had to wait 8 months. DCVax-L had to wait 6 months.
- Finally, the vast majority of drugs that go through this process are approved. I reviewed 24 drugs. 4 are still awaiting approval. Of the remaining 20 applications, 16 were approved, while just 4 appear to have been declined or retracted by the applicant.

The 3 medicines still in the process that predate DCVax-L are:

1. mRESVIA (a medicine indicated for active immunisation of adults 60 years of age and older, to prevent lower respiratory tract disease and acute respiratory disease caused by infection with respiratory syncytial virus). This medicine had its first CHM meeting on 2/22/24. It's a Moderna drug, and it was approved by FDA and EMA earlier this year. It will probably be approved soon.
2. gallium-68 (68Ga) gozetotide (a medicine for diagnostic use only to allow the imaging of prostate cancer). This medicine had its first CHM meeting on 4/25/24. It goes by the name Illuccix, and is owned by Telix Pharmaceuticals. It has been languishing in the process for a long time – this is the poor drug that had to wait a full year for its first meeting. Also, it is the one drug out of the 24 I looked at that publicly mentioned receiving its RFI. One single drug, out of 24. So next time someone tries to tell you it's unusual for a company not to PR updates, know that they are just making that up. And if you are one of the people here clamoring all day every day about the company's "unusual" or "suspicious" strategy regarding communications about this process, know that you are wrong, and everyone here knows you are wrong.
3. Flibanserin(?) (a medicine indicated in postmenopausal women for the treatment of hypoactive sexual desire dysfunction (HSDD), wherein women often feel distress because they have a very low sexual desire / interest to have sex). This one I am less certain of, but available information seems to suggest flibanserin as the most likely candidate. Its first CHM meeting was 6/27/24, the same meeting as DCVax-L's.

Here's the last point I'd like to make:

- The most recent batch of CHM minutes ran through July; no new medicines were addressed during that meeting.
- The earliest any other drugs in the process could have had their first CHM meeting would be August 2024.
- Given the current average of roughly 6 months from first CHM meeting to approval, those drugs wouldn't be approved until February. (I'm not saying it's impossible they could be approved in January, I'm just looking at the average.)
- That leaves a maximum of 4 drugs in the pipeline that could conceivably be approved at any time (the 3 I mentioned plus DCVax-L).
- The MHRA is approving between 2 and 4 drugs each month.

If I were a betting person, I would bet that mRESVIA and DCVax-L will be among the drugs that are approved by MHRA in January.

If you're still reading at this point, I sincerely hope you turn off your computer and have a pleasant New Year's Eve. All the best to you in the upcoming year (and especially in the upcoming month).