Replies to post #750043 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The regulators drive that timing and process, not the company. If they were a part of the expedited process, then NICE is part of that process simultaneously. We know they requested to be in the expedited process, but it does not seem as though they are... so suggesting, in any context, that they are not doing everything possible to expedite something they likely do not control, is perhaps a bit too far. But, I am sure they have likely been doing their work. Regulators tend to drive the schedules and to rarely be in a hurry, unfortunately.

[flipper44]

NWBO hired two consultants that began stage 1 reimbursement preparation, sometime around August 2024 ( August is imo), according to the last 10q. I personally would be disappointed if this has not started with a cancer drug fund referral which, I personally believe can be started before evidence submission to NICE. I think, and this is just me, that interim funding could be used to finance around 30 to 45 million for commercial therapy and parallel Eden testing, in order to gather enough data to then proceed with NICE reimbursement. That’s just my hypothesis, but to me it would account for the timing you and others keep scratching your heads about.

Let me add that, at this time juncture, I don’t think, JMHO, the actual NICE submission will occur until around the end of October. Why? Because that’s ten years from when the last patient was randomized and began treatment on DCVax-l. I don’t agree with waiting that long, but the scientific community (including Big Pharma) is/are drawn to round numbers.

[Doc logic]

Doclee,

Just remember that murcidencel is already on NHS’s high priced medications list which indicates funds are being set aside to pay for a treatment which is highly likely to be approved. This listing is a proactive move by NHS based on what they saw up until that listing was added last year. This just goes to show that the NICE reimbursement work is not sitting in some black hole but rather undergoing some kind of dynamic change in process. This could be related to quality life years growing and helping the reimbursement model to work better for business considerations, NWBO needing to wait on getting Flaskworks into position for commercial scale use viability so the reimbursement model that L must conform to works for the business or a potential partner or something else. Most likely though this is a business model consideration delay because of the high costs involved with a personalized treatment being made available on a commercial scale.
Big pharma didn’t want to spend the time figuring this out and wrote the treatment off for this reason believing either the treatments would be unapprovable or the manufacturing process too complicated and costly to lead to a profitable enterprise. Now they recognize that they will soon be playing second fiddle and are in no hurry to acknowledge this; ).
There is also another way to interpret what Linda said because the statement you referred to did not say MAA approval but rather just MAA which is the submission for approval. Granted, approval might be the missing word being implied but since it was not stated the wording can also imply an order of things that would happen after the application was submitted. Viewing it this way points to the preparations for manufacturing that occurred after submission which includes the MIA Human designation received at Advent along with whatever else the company is working on potentially with partners or other undisclosed happenings.
The 9-12 month time line that FeMIKE points to is a realistic look at current info regarding NICE reimbursement timing. The set asides are separate from what he was focusing on but I believe should also be mentioned as a side note in his discussion as it involves NHS funding being planned for even if amounts are currently unknown. Best wishes.

[FeMike]

The following exhortation was appended: "I think what they [NICE] say matters and not rumors and innuendos. Hang in there, Dave."

Okay, fair enough. Let's go by what NICE says. NICE says that they have not received an evidence package yet (receipt of this is recorded in their project database). NICE also says that the timeline from evidence submission to guidance is 29-38 weeks. So make from that what you will.

So please, don't take me by my word. But I'd strongly caution you to trust Dave/the company on this matter. As Dave says, let's refer to NICE and what they say.

Look, I hope I'm wrong too. I hope somehow NWBO has convinced NICE not to update their project database so they can take those rascally little shorts by surprise. Seems odd that NICE would participate in such an activity, but if that's what y'all are banking on sure, let's hope for that.

I'm just trying to make sure everyone is being realistic with expectations and won't be caught off guard when NICE isn't scheduling DCVax in an appraisal meeting 2 weeks after approval.

[exwannabe]

Am I to accept that for the last year since the ASM nothing has happened behind the scenes to advance DCVax-L's acceptance into the NHS's Therapeutic Armamentarium? Only time will tell ... and I hope that you are wrong. But, if you have been right all along, I will hold Management to be responsible for any delay in starting NICE's processing of the application for DCVax-L to be accepted into NHS usage.

So NICE asked NWBO for the evidence submission in Dec '22. And NWBO announced they just hired contractors to start on it in Q3 2024.

I guess in LP time that is not a delay. OK.

[FeMike]

And just to make sure I've got all sides of the argument.

You requested my facts for why I think NICE guidance is months away. Can I request your facts for claiming that reimbursement will be fully negotiated upon approval? I expect your answer to be based on facts, not on supposition or whimsy.

That question is somewhat sarcastic and somewhat serious. Am I missing something? Why do we think NWBO can cut corners on the NICE appraisal?

[FeMike]

Am I to accept that for the last year since the ASM nothing has happened behind the scenes to advance DCVax-L's acceptance into the NHS's Therapeutic Armamentarium? Only time will tell ... and I hope that you are wrong. But, if you have been right all along, I will hold Management to be responsible for any delay in starting NICE's processing of the application for DCVax-L to be accepted into NHS usage.

You ready to hold management accountable yet?

No, I suspect not. I'm sure you have other excuses.