[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Andrew Caravello, DO [@andrewcaravello](/creator/twitter/andrewcaravello) on x 1072 followers Created: 2025-07-15 18:11:38 UTC đ If the July XX NICE Letter Is Real, Then MHRA Approval Is Functionally Complete Hereâs the Step-by-Step Explanation: â ď¸ This analysis assumes the July 15, 2025 letter from NICE is genuine and accurately reflects $NWBO current status in the UK regulatory process. As per the actual NICE submission manual. That document makes one thing clear beyond all doubt: The statement from NICE that NWBO is ânot yet in a position to submitâ does not signal delay or failure. It is exactly what we would expect at the very end of the regulatory process, during the labeling phase. đ Direct link to the NICE submission guide (PMG24): â Step-by-Step: What the Process Actually Requires đš X. MHRA must approve the therapy before NICE can evaluate it. In the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) is the first gatekeeper. It reviews all clinical trial data and decides whether a treatment like DCVax-L is safe and effective. Only after MHRA approves can NICE begin its part. đš X. After MHRA approval, the product label (SmPC) is finalized. Once MHRA reaches a positive decision internally, they begin drafting the Summary of Product Characteristics (SmPC). This document is the official âlabelâ that: â˘Specifies what the drug is approved for â˘Who can receive it â˘How it is to be used â˘What risks and side effects are involved You do not get an SmPC before approval. Itâs only written after approval is granted internally. đš X. NICE legally cannot accept an evidence submission until the final label is issued. This is explicitly stated in the NICE submission rules: âCompanies must base their submission on the final scope issued by NICE and the final SmPC (or equivalent) as approved by the licensing authority.â đ Source: Page XX of the official NICE guide đ In other words: â˘NWBO cannot submit to NICE until MHRA gives them the final SmPC â˘The SmPC only comes after approval is already decided â˘So when NICE says NWBO is ânot yet in a position to submit,â that means theyâre waiting on MHRAâs final label, not scrambling to find data đ What Stage Are We in Right Now? đ§ Based on NICEâs letter and their own guidance: â˘MHRA has likely completed scientific review â˘The decision to approve has likely already been made internally â˘MHRA is now in the label finalization phase (finalizing the SmPC) â˘NWBO is waiting for the label so it can submit to NICE â˘This step is normal, final, and required Once NWBO receives the label, the NICE submission process begins. đ§ Why âNot Yet in a Position to Submitâ Is Actually Reassuring Some people misunderstood the phrase as a red flag. But the actual NICE guidance proves the opposite. It tells us: â˘NWBO is not allowed to submit because the label isnât ready â˘And the label only comes after MHRA has approved That means: âNot yet in a position to submitâ = Weâre in the final administrative step before public approval No delay. No problem. Just sequencing. đ Summary (Plain English) If the July XX NICE letter is legitimate: â˘â MHRA has already decided to approve DCVax-L â˘â MHRA is now finalizing the legal label (SmPC) â˘â NWBO canât submit to NICE until it receives that label â˘â This is exactly how the process is designed to work â˘â Thereâs no red flag, just normal end-stage procedure â ď¸ Final Disclaimer for Clarity This interpretation is based on the assumption that the July 15, 2025 letter from NICE is authentic and accurately reflects Northwest Biotherapeuticsâ regulatory status. The procedural explanation is drawn directly from NICEâs own published guidance here: đ This post is for informational purposes only and does not constitute investment advice. XXXXX engagements  **Related Topics** [$nwbo](/topic/$nwbo) [Post Link](https://x.com/andrewcaravello/status/1945184497411956827)
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Andrew Caravello, DO @andrewcaravello on x 1072 followers
Created: 2025-07-15 18:11:38 UTC
đ If the July XX NICE Letter Is Real, Then MHRA Approval Is Functionally Complete Hereâs the Step-by-Step Explanation:
â ď¸ This analysis assumes the July 15, 2025 letter from NICE is genuine and accurately reflects $NWBO current status in the UK regulatory process.
As per the actual NICE submission manual. That document makes one thing clear beyond all doubt:
The statement from NICE that NWBO is ânot yet in a position to submitâ does not signal delay or failure. It is exactly what we would expect at the very end of the regulatory process, during the labeling phase.
đ Direct link to the NICE submission guide (PMG24):
â Step-by-Step: What the Process Actually Requires
đš X. MHRA must approve the therapy before NICE can evaluate it.
In the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) is the first gatekeeper. It reviews all clinical trial data and decides whether a treatment like DCVax-L is safe and effective. Only after MHRA approves can NICE begin its part.
đš X. After MHRA approval, the product label (SmPC) is finalized.
Once MHRA reaches a positive decision internally, they begin drafting the Summary of Product Characteristics (SmPC). This document is the official âlabelâ that: â˘Specifies what the drug is approved for â˘Who can receive it â˘How it is to be used â˘What risks and side effects are involved
You do not get an SmPC before approval. Itâs only written after approval is granted internally.
đš X. NICE legally cannot accept an evidence submission until the final label is issued.
This is explicitly stated in the NICE submission rules:
âCompanies must base their submission on the final scope issued by NICE and the final SmPC (or equivalent) as approved by the licensing authority.â
đ Source: Page XX of the official NICE guide đ
In other words:
â˘NWBO cannot submit to NICE until MHRA gives them the final SmPC â˘The SmPC only comes after approval is already decided â˘So when NICE says NWBO is ânot yet in a position to submit,â that means theyâre waiting on MHRAâs final label, not scrambling to find data
đ What Stage Are We in Right Now?
đ§ Based on NICEâs letter and their own guidance: â˘MHRA has likely completed scientific review â˘The decision to approve has likely already been made internally â˘MHRA is now in the label finalization phase (finalizing the SmPC) â˘NWBO is waiting for the label so it can submit to NICE â˘This step is normal, final, and required
Once NWBO receives the label, the NICE submission process begins.
đ§ Why âNot Yet in a Position to Submitâ Is Actually Reassuring
Some people misunderstood the phrase as a red flag. But the actual NICE guidance proves the opposite. It tells us: â˘NWBO is not allowed to submit because the label isnât ready â˘And the label only comes after MHRA has approved
That means:
âNot yet in a position to submitâ = Weâre in the final administrative step before public approval
No delay. No problem. Just sequencing.
đ Summary (Plain English)
If the July XX NICE letter is legitimate: â˘â MHRA has already decided to approve DCVax-L â˘â MHRA is now finalizing the legal label (SmPC) â˘â NWBO canât submit to NICE until it receives that label â˘â This is exactly how the process is designed to work â˘â Thereâs no red flag, just normal end-stage procedure
â ď¸ Final Disclaimer for Clarity
This interpretation is based on the assumption that the July 15, 2025 letter from NICE is authentic and accurately reflects Northwest Biotherapeuticsâ regulatory status. The procedural explanation is drawn directly from NICEâs own published guidance here:
đ
This post is for informational purposes only and does not constitute investment advice.
XXXXX engagements
Related Topics $nwbo