NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Nem,

What does holly have to do with anything? 😶☃️🎄 …Are you predicting approval around the winter holiday season?

Thanks for highlighting the topic of regulatory applications though...

Your posts about the sequence of steps reminded me of the timing of the updates that were published on the NICE website …

I think that the NICE status updates that were posted exactly 12 months in advance of the December 2023 MAA submission are significant.

From an AI app:
“The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are two key organizations in the UK's healthcare system, each with distinct roles, and their processes are interconnected, especially in the context of a Marketing Authorization Application (MAA).

Here's how the MHRA MAA impacts the NICE process:

1. Role of MHRA: The MHRA is responsible for assessing and approving new medicines for use in the UK. This includes reviewing Marketing Authorization Applications (MAAs) to ensure the safety, quality, and efficacy of new drugs.

2. MHRA Approval: When the MHRA grants a marketing authorization for a new drug, it means the drug can be legally sold and marketed in the UK, and the drug can be made available through the NHS.

3. NICE Appraisal: After MHRA approval, the drug may undergo a health technology assessment by NICE. NICE evaluates the cost-effectiveness and clinical effectiveness of new medicines to determine whether they should be recommended for use in the NHS.

4. Impact on NICE Process: The MHRA’s decision to authorize a drug is a prerequisite for NICE's appraisal. NICE does not assess the basic safety and efficacy of a drug; it relies on the MHRA's evaluation for that. Instead, NICE focuses on the added value of the drug in terms of health outcomes and cost-effectiveness.

5. Timelines and Access: The MHRA’s approval of a drug directly impacts when NICE is able to complete its appraisal, subsequently affecting when a drug becomes available on the NHS.

6. Collaboration and Parallel Advice: In some instances, the MHRA and NICE work in parallel to provide advice to drug developers, which can streamline the process of getting new treatments to patients.

In summary, MHRA’s MAA is a critical step that directly influences the NICE appraisal process. While MHRA focuses on the safety and efficacy of a medicine, NICE assesses its cost-effectiveness for NHS use.”

The forthcoming NICE appraisal of the DCVax-L cell-based technology will be another significant development.

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143




The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. Further announcements and status updates are forthcoming.

The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA was a prerequisite of the MAA application that was submitted in December 2023.

“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html

https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html