Replies to post #750053 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

You appreciate facts... I think my take on the fact is more correct, when you look at the fuller context of the discussion. :)

I disagree with you but, sure, let's toss that one.

Now let's address the other facts I posted that show DCVax won't get NICE guidance/NHS reimbursement any time in the next 6 months.

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An evidence submission is a concise, comprehensive and structured report of all relevant information (published and unpublished) for an appraisal.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 Draft guidance produced
The evaluation committee makes its provisional recommendations in the draft guidance. Stakeholders have 4 weeks to comment on the draft guidance.
Following consultation on the draft guidance a second committee meeting is held, this usually occurs 2 months after the first committee meeting.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 Final draft guidance produced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.

[FeMike]

You appreciate facts... I think my take on the fact is more correct, when you look at the fuller context of the discussion. :)

Still think your take on the 'facts' is more correct than mine?

NWBO has done nothing with NICE in the past 6 months. And will do nothing until after approval. Just like I said.

Big FUDster Mike right again.