NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

I am of the opinion that approval will come very soon. I initially proposed a likely approval window in October, about 6 weeks before the latest batch of CHM minutes came out. That window was based on the most recent CHM minutes available, which were from 2023. Thanks to the batch that was released in December (which, of course, included DCVax-L), we have access to more and more recent data on how long these approvals are taking. Here are the Cliffs Notes of what that has led me to believe:

- Average time between first CHM meeting and approval for medicines that appear to have had their first CHM meeting in H1 2024 AND have already been approved: 6.43 months
- Knocking off high and low outliers, average approval time is 6.2 months, with a range of 5 months to 8 months.
- DCVax-L's meeting was at the end of June 2024. Therefore, it would be reasonable to expect approval between December 2024 and February 2025.
- With an average duration of 6.2 - 6.43 months from the first CHM meeting to approval, we would be looking at the middle of that range: mid-January 2025, i.e. right now.

This mostly coincides with the earlier window I proposed, with the exception that the end-of-February target is specifically based on the MHRA's recent performance with other medicines this year, whereas the earlier end-of-January target was based on the predicted date by which they would have completely cleared their backlog and gotten back on track to hitting statutory timelines.

Given that MHRA has now announced that the backlog has been cleared, and that there are at most 2 other drugs ahead of DCVax-L in the pipeline, I still feel good about my suggestion.

One caveat is that, assuming the other 2 drugs (mRESVIA and gallium-68 gozetotide) were approved this month, the average time from first CHM meeting to approval would rise to 7.14 - 7.2 months. That would push DCVax-L's likely approval (based on recent averages) into early February. But at that point, there would also be 0 medicines ahead of us in line...

This is all my personal opinion of course, based on analysis of the available data.