Replies to post #748948 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Thank you TVP! Your DD has been a bright spot these past several months.

”This medicine had its first CHM meeting on 4/25/24, 2 meetings prior to DCVax-L. There were 293 days between its first meeting and today. (Incidentally, that proved to be exactly 2.5 standard deviations away from the mean based on recent MHRA performance.)

DCVax-L is currently sitting at 230 days since its first CHM meeting. However, in my eyes what's more important is that I believe there are now 0 medicines "ahead" of us in the approval pipeline. For the 24 medicines in the pool I've been tracking:

- 20 have been approved
- 3 have not been approved (including mRESVIA)
- 1 is pending (DCVax-L)

As I've mentioned before, I believe that no new medicines were addressed at the July 24 CHM meeting, so August would be the earliest any other medicine could have been addressed for the first time. Medicines can and frequently are approved out of order, so it's far from impossible that we could get approval news for another medicine before DCVax-L – though looking at the numbers, that seems unlikely. It's also possible that we could still get a mRESVIA approval sometime, too.

That being said, the runway appears clear for DCVax-L approval next.”

[tunnelvisionofplenty]

One thing I've noticed recently, and which this approval today corroborates, is that ever since IRP approvals have been ramping up, the rate of regular national pathway approvals has been declining. Previously, it would be normal to see 2 or 3 national pathway approvals per month; since IRP approvals started rolling in (this past fall), there's been exactly 1 national pathway approval per month, along with a minimum of 1 IRP approvals per month. Also, the average time from first CHM meeting to approval has increased for the 4 national pathway medicines approved since November: ~295 days, compared to ~209 days for medicines approved over the past 2 years.

This is way too small of a sample size to draw any real conclusions from, but it is interesting to note.

[ilovetech]

Tunnelvision - Great DD! It's much appreciated. 👍

[StonkMaster]

$NWBO

New MHRA Assessment Data is out for January 2025. More progress made with (3) NAS MAA applications reaching determination in 286 clock-on days.https://t.co/yTUhN1sfCA

— StonkMaster (@StonkMasterJ) February 14, 2025

[Lykiri]

It's also possible that we could still get a mRESVIA approval sometime, too.

mRESVIA RSV vaccine approved to protect patients aged 60 and over against lower respiratory tract disease caused by RSV.
The new marketing authorisation was granted on 27 February 2025 to Moderna Biotech Spain.
https://www.gov.uk/government/news/mresvia-rsv-vaccine-approved-to-protect-patients-aged-60-and-over
This medicine had its first CHM meeting on 2/22/24.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722451876042