Replies to post #728108 on NorthWest Biotherapeutics Inc (NWBO)

[RobotDroid]

Nice summery. So, I was correct with 2025 being the most likely time frame for UK approval. Until then, expect new lows and silence from the mute inept nonmanagement clown show.

[flipper44]

Thanks for your DD. Question below.

How many of your samples proceeded under the accelerated program?

[exwannabe]

Well, that was certainly some good digging. Well done.

I would add one point to it. The second CHM meeting (if used, it is optional) is where the CHM provides their recommended thumbs up/down. So it is close to the end.

If there are still issues after that the sponsor, CHM or MHRA can request an oral hearing to argue their point / submit information. That process can take 6 months or more.

Schedule 11 of the UK Health and Medicines Act of 2012 describes this.See paragraphs 5,6 and 7. Schedule 5 of the above discusses the timeframe. There is a mention in Part 5 , para 58 that an oral presentation causes a clock stop. Which can be over half a year per the above timelines.

That is consistent with your observations on the 2 alzheimers approvals. They were both debatable and it looks like they did want to further discuss the approval.

[newman2021]

Thanks for your analysis tunnelvision and it makes sense. I second 11/14. This is the 10Q day or 2 days after the 10Q. Interesting days ahead indeed!!

[newman2021]

How would the NICE labelling timeline play out if the approval is slatted for the 14th of November? NICE pricing done before or after approval?? We get nGBM and rGBM 2 labels right??

11/14 is going to crush the shorts, imo.

[Goats'nCrows]

Thanks for sharing your hard work.

Very nice.

[learningcurve2020]

Remember too that NIH appointed the CHM team since it's a cell therapy. I suspect it's going to take much longer.  

[CrashOverride]

Thank you very much!

[flipper44]

Hello TOV, while your reasoning seems most (conservatively) likely, I think there are three possible reasons there might be alternatives.

1. You only found one accelerated in the last two years, and it was validated a year earlier when the backlog was huge and decision time averages were lengthy.

2. #1 above would mean that there were a few to several accelerated approvals that did not require the second OPTIONAL CHM meeting.

3. Your post states approval likelihood is 100%. While I tend to agree the odds are extremely high, I don’t think it’s in the bag until announced.

[Hopeforthefuture3]

tunnelvisionofplenty, much thanks for all the work - very good data. Not asking you to do any more digging but in your research did you find any data as to how long it took to get NICE approval for insurance coverage? I ask because of the comments by LP at the June asm.
LP comments:
We talk to them. They reach out to us every couple of months to check on the status of things. I mean, I couldn't imagine a government agency, that's been so supportive as they've been. What we will need to do is, we'll need to engage specialized consultants to develop, what's referred to, as a health economics model. We have to make an economic model about the cost benefits of the DC vaccine treatment, and how it fits with their policies, and that sort of thing. So, that for sure will be, in our grouping of top priority activities, over the, as we look forward, over the coming 18 month period, 12 months, whatever.

[CaptainObvious]

Nice work!

[scotty3371]

Exactly

[Hopeforthefuture3]

tunnelvisionofplenty, I took 2 of the meds on your list to see how long it took from approval in UK to get to final published decision by NICE for coverage. First was Donanemab by LLY but on their web site could not find much so went to second drug Ritecitinib by PFE. They (PFE) had date of approval on their web site as of 6/23/2023. Struggled to find insurance coverage but finally ended up at UK NICE site and final comments were due March 7, 2024 and NICE final report published March 27, 2024 and is covered. So it took from June 2023 to March 2024 to get the NICE coverage.
I hope nwbo can get a quicker result with NICE or we will be waiting for a while. LP did make good comments about relationship with NICE so can hope

[Chiugray]

TVP, Great post and super helpful.

Connecting dots. I am wondering if the 2nd meeting could have happened at the 26 and 27 September 2024 CHM meeting.
- Final steps of the review, manufacturing inspections, likely took place in August
- MHRA change Advent Bioservices’ MIA status from "investigational" to "Human" on 9/6/24

But likely that was too tight a timeframe for inclusion into the meeting. Then it would have fallen onto the next scheduled meeting, 24 and 25 October 2024, as in your original post.

[JFR161162]

Great comment.
May I ask you what's your background?
Thanks 

[flipper44]

I think the 10/31 loan NWBO received potentially covers this time frame you arrived at, assuming we had an Oct 24/25 CHM meeting.

“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 (aka October 24) (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.”

[manibiotech]

And here is your post from last year .