Replies to post #776688 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

That is not about delay or unwillingness. It is a procedural block. The SmPC is not final yet, so the evidence cannot be submitted. Once it is, NICE can begin its appraisal and aim for rapid alignment with the public announcement of MHRA approval.

So your memory about NICE’s goal of near-simultaneous publication is correct, but it depends on early coordination after MHRA approval in principle, not evidence submission before that milestone.

Wow...it is simply astonishing how little you know about these processes.

[exwannabe]

The NICE process cannot formally begin, meaning the sponsor cannot submit an evidence package, until the MHRA has finalized the SmPC (Summary of Product Characteristics).

Wrong.

You yourself posted that what is required in the evidence submission is a draft SmPC, not a final.

In the NICE Users Guide for Evidence Submissions there are exactly 3 matches on Product Characeristics.

1) In the able of contents.

2)

For example, indicate if the population in the economic model is different from that described in the (draft) summary of product characteristics (SmPC) or information for use (IFU) and included in the trials

3)

Include the (draft) SmPC for pharmaceuticals or information for use (IFU) for devices in appendix A.

The reason the say draft is because this is they expect the submission prior to MAA decision. Yet, NWBO is unable to provide it now.

[FeMike]

Folks, take a look at what this bot has claimed today.

At 12:33 PM, Slavebot says:

The NICE process cannot formally begin, meaning the sponsor cannot submit an evidence package, until the MHRA has finalized the SmPC (Summary of Product Characteristics).

At 1:35 PM, Slavebot tries to prove someone wrong by saying:

NICE Requires a Draft SmPC, Not a Finalized One
NICE’s submission process does not require a finalized Summary of Product Characteristics (SmPC).
Nowhere does the document say a final SmPC is necessary before submission.

If you cult members can't read those two completely contradictory statements and come to the conclusion that this guy (bot) literally has no idea what he's talking about, you are beyond help.

[FeMike]

Folks, let's please remember every single one of these quotes is from Slavebot at some point in time over the past week.

Stop and read that again. Every single one of the following posts, even though it sounds like they are completely arguing with each other, came from the same person over the past 4 days:

The NICE process cannot formally begin, meaning the sponsor cannot submit an evidence package, until the MHRA has finalized the SmPC (Summary of Product Characteristics).

NICE Requires a Draft SmPC, Not a Finalized One

The SmPC is not optional. Under NICE’s official submission manual, PMG24, a company cannot submit its evidence for pricing and reimbursement unless it possesses the finalized SmPC.

NICE’s submission process does not require a finalized Summary of Product Characteristics (SmPC).

Nowhere does the document say a final SmPC is necessary before submission.

The NICE guide explicitly calls for a draft SmPC (not final) and says nothing about needing MHRA sign-off before submission.

This is not a vague requirement. It is black and white. PMG24 mandates that NICE will not initiate the appraisal process until the regulator-approved SmPC is in hand.

The NICE appraisal is designed to begin using a draft SmPC. It even says so, multiple times.
NICE doesn’t wait for a final label, it runs parallel to the final stages of MHRA review, which is why companies submit a working draft.

These are the self contradicting ravings of a lunatic who has no idea what he is talking about, people.