Replies to post #728169 on NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

I don't know, but I'd definitely be interested to look into that!

[Doc logic]

Hopeforthefuture3,

I believe this is Linda’s way of saying they are waiting on Flaskworks for a NICE submission while another funding source may be utilized in the interim (12-18 months from end of June 2024). Otherwise they would have already been working on all of this for an NICE assessment. Everything could have been done except plugging in the final numbers for quality life years in their formula for expected reimbursement. This would be done last minute to get max benefit from the surviving patients who continue to increase the average QLY benefit. Instead, she listed this NICE submission model as a future concern. Best wishes.

[tunnelvisionofplenty]

I spent a little more time looking into how long it took NICE to make a determination on MAAs approved in 2023, and here's what I found:

Out of 13 medicines approved by the MHRA in 2023:
- 7 were recommended by NICE
- 4 are still underway (seemingly on account of delays on the part of the company)
- 1 was not recommended
- 1 was withdrawn from consideration by the company

Of the 7 that were recommended, the average time from MAA approval to NICE recommendation was 101 days.

However, one big caveat is that one of those medicines was Casgevy, aka the world's first licensed CRISPR medicine. That recommendation took 266 days to deliver, which makes sense for such an unprecedented case.

Removing that major outlier, the average time from approval to recommendation for the remaining 6 medicines was 74 days.

Before the usual suspects come out and start making evidence-free proclamations about how bad of a job the company is probably doing engaging with NICE, here's one more observation. For medicines still under review, NICE provides a timeline of "key events during the development of the guidance". For the companies experiencing significant delays with NICE, these timelines are littered with setbacks and confusing changes by the company – for example, take a look at the one for vadadustat, which was approved by MHRA in May 2023.

Compare that with DCVax-L's timeline. If you don't feel like clicking through, the most recent entry on 3/5/2024 says "A meeting was held between NICE and the company in early-February regarding next steps for the appraisal of DCVax-L for treating glioblastoma, and more information will be available in due course. NICE will continue liaising with the company and monitoring timelines."

To me, that indicates that the company is on the ball. I'd be comfortable going out on a limb and predicting that NICE is able to recommend DCVax-L in less time than the average I indicated earlier – that is, less than 74 days after MAA approval.