TheDanishDudeAs retail investors in NWBO, we are all very much aware that this is the “bottom of the ninth”. The story of this little biotech company, its “adversaries” and the “harassments” it has endured on so many levels, through so many years, is what eventually is turned into movie scripts.
I was thinking something along the line of “Shame“.
Mark Faulk, writer and co-producer of ‘The Wall Street Conspiracy,’ has turned his attention to a documentary series titled ‘Financial Terrorism in America,’ which will almost certainly cover the spoofing against NWBO.
Behind the current share price of $0.54 lies a tale of deception and disgraceful, denigrating human behavior, so intricate that even a docu-series would struggle to delve beyond the surface of what lay before.
On December 21st, 2023, it was announced that a Marketing Authorization Application (MAA) for DCVax®-L for glioblastoma brain cancer had been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. For retail investors in NWBO, it would be readily apparent that this announcement marked not just the fruit of over two decades of relentless research and effort, but also a pivotal moment where, for the first time, the course of the company’s destiny lay in the hands of others.
There never was a public announced validation or acceptance of the MAA. And as such, the 150-days assessment procedure would have started just after new year. 2024. Now why is that important?
Well, let’s walk back a bit.
February 28th. 2023 – Pathway to a Cure Report
The All-Party Parliamentary Group on Brain Tumours (APPGBT) in the UK is an informal group of Members from both the House of Commons and the House of Lords with a common interest in addressing issues related to brain tumours. Established in 2005 and supported by Ali’s Dream, The United Brain Tumour Campaign, and Brain Tumour Research, the group aims to raise awareness and improve research, diagnosis, information, support, treatment, and care outcomes for the brain tumour community.
The APPGBT’s work is crucial because brain tumours are a significant health issue, being the biggest cancer killer of children and adults under the age of 40 in the UK. Despite this, the funding and research into brain tumours have historically been inadequate compared to other types of cancer. The group has been instrumental in advocating for increased investment in brain tumour research, leading to the Government announcing £40 million in funding for research into brain tumours, further boosted by pledges from Cancer Research UK.
The report released by the APPGBT on February 28th, 2023, compiled by the Brain Tumour Research charity, underscores the barriers to finding a cure for brain tumours and outlines recommendations for improving the situation. One significant recommendation in the report was:
- Explore how the MHRA, HTA, and NICE can cooperate better to enable new treatments tobe made available in the UK, such as immune vaccination, and immune cell therapy which usea patient’s own specific antigens and dendriticcells respectively
- Where possible, external controls such as previous trials data to replace placebos for brain tumour patients.
The report carries significant weight regarding its recommendations for MHRA and NICE for several reasons:
- Awareness and Advocacy: It raises awareness among policymakers and the public about the urgent need for improved brain tumour treatment options and research.
- Policy Influence: Although APPGBT’s reports are not official parliamentary documents, they can influence policy and funding decisions by highlighting gaps and suggesting improvements.
- Stakeholder Engagement: The report reflects input from a wide range of stakeholders, including researchers, clinicians, patients, and families, making its recommendations well-rounded and reflective of the brain tumour community’s needs.
- Potential for Change: By suggesting concrete steps for collaboration between key regulatory and assessment bodies, the report outlines a pathway towards faster and more effective treatment approvals and access for brain tumour patients.
In summary, the APPGBT’s efforts and the recommendations outlined in their report aim to significantly impact how brain tumour research is conducted and how new treatments are developed and made accessible in the UK, urging a more coordinated approach among MHRA, HTA, and NICE.
MHRA Announcement following the report.
March 15th. 2023
Excerpt 1:
“The funding over the next two years will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK’s healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health.”
Did you REALLY get the message?
TWO YEARS
SPEED UP THE APPROVAL PROCESS
CUTTING-EDGE TREATMENTS DEVELOPED IN THE UK
SUCH AS CANCER VACCINES
Excerpt 2:
“It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.“
Only secondary, did the funding mention the International Recognition Procedure (IRP), that later on went live January 1st. 2024.
Excerpt 3:
“Using the Agency’s pre-existing international partnerships developed through the Access Consortium and Project Orbis, the first regulatory partners that the MHRA intends to build new recognition routes with are the FDA, in the USA, and with the PMDA, in Japan.”
So. How about “the other way around?”
https://www.gov.uk/government/news/mhra-to-receive-10m-from-hm-treasury-to-fast-track-patient-access-to-cutting-edge-medical-products
mentions a total of £10 million being awarded to the Medicines and Healthcare products Regulatory Agency (MHRA) to help bring innovative new medicines and medical technologies to UK patients more quickly, A fundingbeing used to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally.
“The funding over the next two years will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK’s healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health.
It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.
The MHRA will still be responsible for the approval of all ‘recognition route’ applications, ensuring that all products are of sufficient quality to be licensed in the UK and it will operate a robust process promoting patient safety and access to improve the health of the UK population.
Using the Agency’s pre-existing international partnerships developed through the Access Consortium and Project Orbis, the first regulatory partners that the MHRA intends to build new recognition routes with are the FDA, in the USA, and with the PMDA, in Japan.”
Please enlighten me about the IRP and these recognition routes.
Is the IRP a bilateral venture, where ALSO the countries in the Access Consortium and Project Orbis, gets able to fast track UK approved drugs?
This article seems to believe so.
https://www.gov.uk/government/news/mhras-new-international-recognition-procedure-irp-goes-live-from-1-january-2024
“RP allows us to access the expertise of trusted regulatory partners, who have already authorised products. In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients.”
Answer from ChatGBT
The information you’ve shared outlines a significant development in the regulatory landscape for medicines and medical technologies in the UK, spearheaded by the Medicines and Healthcare products Regulatory Agency (MHRA). The focus here is on the allocation of £10 million to the MHRA for accelerating patient access to innovative medical products, through both a streamlined approval process for UK-developed treatments and an international recognition framework. This initiative appears to be part of the broader goals of the Spring Budget.
International Recognition Procedure (IRP) and Recognition Routes
Based on your description, the IRP is designed to facilitate a more efficient and reciprocal regulatory approval process for medical products. Here’s a breakdown of how it works and its implications:
IRP and Its Bilateral Nature: The International Recognition Procedure (IRP) indeed seems to be a bilateral venture, as it allows for mutual recognition of medical product approvals between the MHRA and its regulatory partners. This procedure is not only about speeding up the UK’s access to medical products approved in other countries but also about allowing these partner countries to fast-track products approved in the UK. It creates a reciprocal, beneficial relationship aimed at enhancing patient access to innovative treatments across participating countries.
Recognition Routes with Access Consortium and Project Orbis Partners: The reference to building new recognition routes with the FDA (United States Food and Drug Administration) and the PMDA (Pharmaceuticals and Medical Devices Agency of Japan) indicates a strategic effort to leverage existing international partnerships. Both the Access Consortium and Project Orbis are collaborative projects involving multiple countries’ regulatory agencies, aimed at facilitating the availability of high-quality, effective medical products to patients more rapidly.
Access Consortium: A collaboration among regulatory agencies from several countries, including the UK, Canada, Australia, Singapore, and Switzerland, aimed at harmonizing and streamlining the drug approval process.
Project Orbis: An initiative led by the FDA to provide a framework for concurrent submission and review of oncology products among international partners, aiming to speed up the availability of cancer treatments.
Benefits for UK and Partner Countries: The establishment of these recognition routes under the IRP implies that both the UK and its partner countries can benefit from each other’s expertise and regulatory decisions. This arrangement not only speeds up the process of making cutting-edge treatments available to patients but also fosters international cooperation in the regulatory review process, which can lead to higher standards of patient care and safety.
In essence, the IRP represents a strategic move towards a more collaborative and efficient international regulatory framework for medical products. By enabling mutual recognition of drug approvals, it aims to facilitate quicker access to innovative treatments, benefiting patients in the UK and partner countries. This initiative underscores the importance of international cooperation in the healthcare sector, particularly in the fast-paced and evolving landscape of medical innovation.
