Replies to post #775976 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

I don't think that's true (but would be happy to be proven wrong). I'm fairly confident you can apply/submit an evidence submission concurrently with MHRA review. NICE themselves have said they try to aim reimbursement with MHRA approval, which wouldn't be possible if you needed to wait for approval to submit.

[FeMike]

Correct me if I am wrong ( politely please ) but I was under the impression that you could not file with NICE until we have marketing approval?

You can file - NWBO actually has filed.

There are just varying steps in the process that usually don't happen until after approval.

The the next major milestone for the company and NICE is for the company to supply NICE with its evidence submission. This is the step that can happen prior to approval, but generally doesn't, and in NWBO's case we have just confirmed (from NICE) it has not happened. This is basically the step that officially kicks off the appraisal process.

See my post linked below for an outline of how the process works and please believe me when I say this is how it will work for NWBO. They do not have any expedited shortcuts to take to make this process faster, no matter what the fake long pumpers try to claim.

Overview of how the NICE Timeline will work for DCVax-L Reimbursement

[Zadie420]

I might be correct. I don't think we can file without MHRA approval. I am not expert in U.K policy regarding this matter. Hoping someone from our great experts in this board chives in here.

[Chiugray]

Exkitteryff, You are basically correct.

The NICE email response to Flipper of “However, we understand that the company are not yet in a position to provide their evidence submission with us,” just means NWBO is waiting for issuance of a Marketing Authorisation (MA) by the MHRA.

The FUDsters just want to make this into something it is not. Official approval is a prerequisite. NICE can begin some pre-appraisal activities before MA, but their full evidence submission and final guidance is fundamentally tied to the product having an MA. I am not an expert in this but this is from the NICE website:

What this means
The applicant makes an application to the MHRA for a GB [Great Britain] marketing authorisation through either the IRP or national licensing route.

• Arrangements and timing of company submissions to NICE are decided based on expected MA date, unless a delay to submission is requested and agreed.
• Prior to issuing final guidance, NICE will ensure that the MHRA has issued a GB marketing authorisation.
• In circumstances where there is a delay to the GB marketing authorisation, NICE will delay publication of final guidance.

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/uk-licensing-and-technology-appraisals

[exwannabe]

Correct me if I am wrong ( politely please ) but I was under the impression that you could not file with NICE until we have marketing approval?

Yor are wrong.

NICE cannot go public until an MHRA approves the MAA but the NCIE process is expected to start well prior.

. NICE notes they seek to publish the draft opinion concurrent with the MHRA decision. Obviously they need to start in advance.
. NICE has published draft guidance the same day as an MHRA decision.
. NICE publishes timelines of opinions and it is easy to find evidence submissions well prior to the MHRA decision
. NICE published the expe3cted timely for a timely opinion stated the evidence should be submitted at least 6 months prior to expected MHRA decision.

If you care I can provide you exact links, but it should not take you than long searching the NICE website to find all this.

As far as evidence in support of your impression, you will find none unless you count posts from Slave1/AC.