Replies to post #748663 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Let's see, facts....hmm....where are some facts.....ah yes, here we go:

1) Linda Powers said at the ASM, for a fact, that they will go through the process of applying to NICE for reimbursement AFTER the MAA.

After the MAA, and the commercialization preparation, and those activities, we also need to go through the process of applying for approval for reimbursement. So in the UK, that's a process that is handled by NICE. And NICE has been absolutely wonderful to us. I cannot say enough things wonderful about NICE. They've been supportive. They've been flexible. They're standing by.....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.

So by Linda's own admission at the ASM, 18 months from the ASM would be December of 2025. That's still 10 months away. If you go by her 12 months, that is still 4 months minimum, but let's be honest. NWBO has never been ahead of schedule. And that's pretty close to a fact.

2) NICE has published the steps in the appraisal process.

For the sake of sticking with facts, we will assume that NWBO has covered everything in steps 1-4 by the time the MAA is approved (they haven't, but since you require facts and not supposition or whimsy or common sense, we'll pretend) and we will jump ahead to step number 5. We know they haven't submitted an evidence package because both NICE and Linda Powers have confirmed this, so that's as far in the process as I'll let this exercise advance.
(These steps are from this link)

The Steps:

1. Provisional appraisal topics chosen
The NICE topic selection programme produces a list of provisional appraisal topics.
2. Stakeholders identified
Technology appraisal stakeholders can be either consultees or commentators.
3. Scope prepared
NICE develops a scope.
4. Appraisal topics referred
The Department of Health and Social Care refers technology appraisal topics to NICE.
5. Evidence submitted
An evidence submission is a concise, comprehensive and structured report of all relevant information (published and unpublished) for an appraisal.
6. External assessment group or assessment report prepared
An independent academic centre is commissioned by NICE to prepare a report.
7. Committee papers prepared
These include all of the evidence that will be looked at by the evaluation committee.
8. 8. Evaluation committee
An independent advisory committee considers the report created in step 6 and hears evidence from nominated clinical, patient and NHS commissioning experts.(we would know if we'd gotten to this step by now, because these committee meetings are public record)
9. Draft guidance produced
The evaluation committee makes its provisional recommendations in the draft guidance. Stakeholders have 4 weeks to comment on the draft guidance.
Following consultation on the draft guidance a second committee meeting is held, this usually occurs 2 months after the first committee meeting.
10. Final draft guidance produced
11. Guidance issued

So based on just that, we've got 3 months minimum from step 9 before guidance is issued. As a footnote, NHS still has 3 months to start reimbursement from final guidance being issued, so up to 6 months alone just from step 9.


3) NICE also has a beautiful timeline of the entire appraisal process for you to take a look at.

You can look at these facts by clicking this link!

According to this, it is a 38 week process without draft guidance (47 week process if draft guidance is necessary). If we pretend they are already ready to submit the evidence package immediately upon MAA approval (again, they aren't, but we're pretending for facts), it is a 29 week process (38 week with draft guidance).

29 weeks is 7ish months.

We are, as a matter of fact, no closer than 7 months from NICE guidance from the date of approval. Very likely 9-12 months in actuality.

You're welcome in advance. Is that factual enough for you? Y'all should give me more credit than you do for doing all of your DD for you.

[FeMike]

DocLee,

You asked me to supply you with facts to back up my NICE prediction.

I did your DD for you, I supplied you with facts and you haven't responded.

Is it safe to assume you are well enough persuaded? Or do you still want to pretend I'm just some no good FUDster that makes things up on supposition and whimsies because I like to be pessimistic and create false timelines?