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Harvests DC cell from patients tumor, then antigen loaded DC cell dermal injection back to the patients. Who does that ? LOL. Crowns.
Thank you for posting this information Starric. Now I can clearly see how big and revolutionary the personalized cancer vaccine treatment really is. On the pictorial diagram, you can see that the only treatment shown at this time is the blue color DCVAX cell going back to the cancer cell assuming the mRNA is way behind us. Like LP said the last ASM, the industry is just waking up with this new technology and it's truly exciting time ahead of us as an investor in this early stage of the revolutionary DCvax based immunotherapy.
LP - No RFI yet from MHRA but we are expecting one like most biopharmas. After 157 days into MAA validation means maybe no RFI no ? She just being cautious IMO.
The final countdown started June 22, 2024. Any day now we longs will be sailing away to the moon. Who's going to stop us, shorts ? LOL
Just a reminder, the validation of the MAA was on Jan 24, 2024, which make it June 22 150th day of the new streamline approval process. Yes, it is this week I am expecting the approval to come through - MHRA got something to prove that they can make this new approval process work. Any day now!
So you and I on the same page as to how wonderful DCVAX is for cancer treatment, but the question remains why DCVAX is being covered up with mRNA and other up coming cancer treatment, including media, institutions and NWBO management silence. If DCVAX is as effective and miracle drug for cancer treatment as we think it is,
the company and the institutions concern maybe that the meeting the deluge demands by desperate cancer patiences around the world which may create untenable situation for the company and the institutions for unable to deliver the drug in a timely manner creating social upheaval. It just doesn't make sense to keep this wonder drug under the lug by all parties at this point in time other that this reason.
Moderna mRNA cancer vaccine for colorectal cancer is being trump by NHS and ASCO 24 which only targets 5 or 6 known antigens in Phase I, no mention of DCVAX L. This is truly baffling to me. Nature article on DCVAX plus Poly iclc is unheard of in any cancer treatment which we can hope for ultimate cancer cure but no media coverage. Why NWBO is not clamoring this result - are we waiting to be buyout. Just thinking out loud.
Cementing MAA by LP should be just about now.
I believe Les Goldman as creditiable at this time " They are on track for accelerated approval, 150 days." According to this new MAA 150 approval guideline, MHRA has to notify the applicant if their MAA can be assess in that 150 day with the Phase I assessment completed, which should have been done in April 2024. I am pretty confident that the company has been notified of this assessment by now. GLTAL.
Base on this MHRA 150 day approval process guide line, RFI is generated during the CHM meeting. If no issues and concerns by the CHM board members during the meeting no RFI is need. Then MHRA can confirm the company that their MAA will be assess in 150 day approval process; therefore, in the last 10Q the company said there were no question, communication from MHRA which I take that as no RFI. By now MHRA should know if they can process the MAA in 150 days or not and should have been relay to the company. With this information, the company can set the date for ASM, maybe sign a licensing deal or two. AMO.
NWBO submitted MAA on DEC 20, 2023 to meet the CHM meeting on March 14,2024,
NWBO received MAA Validation Notice on Jan 20, 2024,
The Phase I 80 day review end on April 9, 2024,
If we don't receive RFI by then, Phase II will start from April 10, 2024 since RFI is issue in between Phases,
Phase II 70 day ends on June 20, 2024.
The assessment timetable will begin after validation of the application.
iii) Assessment process and expert advice
The assessment process includes consultation with the Commission on Human Medicines (CHM) on fixed dates each month.
The submission slots will be linked to the dates of CHM meetings.
The MHRA may additionally wish to seek advice/input from therapy area experts (specialty expert groups) during the assessment process.
The phases of the assessment process
The assessment process will run in two phases totalling 150 days
There will be an intervening clock-off period between phase I and phase II, if required.
Assessment phase I
This phase will be completed 80 days after the clock starts.
Issues arising/requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted exceptionally.
Applicants may contact the assessment team for discussing issues raised in the RFI letter.
Assessment in phase-I will also address eligibility for grant of orphan status.
Assessment phase II
This will commence on receipt of the applicant’s responses fro phase I.
Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings.
Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
iv) Appealing a decision to refuse
If the MHRA proposes to refuse to grant the MA based on advice from CHM, there is an opportunity for the applicant to request a review of the decision.
The procedure for such review is set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations.
The MHRA decision letter will detail the appeal process and timelines.
The orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.
v) Publication
Conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.
If I am the MHRA approving authority for DCVAX-L, with the PH II Combo Safety Data and unexpected spectacular efficiency, with the regulator boundary that you just quoted, it would be a grave error not to approved it at this time assuming NWBO also have submitted this combo result the same time. Patience need this combo drug now! Well thought out speculation my friend. GLTALs.
Very interesting indeed, LP being board member of Revlmmune if I recall right. Seem like they have been working cooperatively for a long time to get to this clandestine goal of cancer cure. I hope to see DCVAXL gets approved with Poly iclc would be the pleasant surprise for all of us and a big win for cancer patients.
Oncovir Andres S, CSO; Mathew B, Pr, seem extremely enthusiastic lately over their Hitonol and I ask myself why suddenly after the combo trial PH II result. So what are they waiting for other than financial source to further their endeavor with vaccine combo trials. Or are they waiting for DCVX-L plus Hiltonol combo approval by MHRA with us? ChatGBT think so with right data submission with the DCVAX _L MAA application. Just might be so. GLTALs!
Sound logical speculation! To be honest, I wasn't too trill with this DCVAX-L alone P III result other than it's a break through in viable GBM treatment. But with this combo P II result, I am speechless and firm believer of all hoopla about cancer cure is coming soon!
CHM committee advise MHRA not the company in the MHRA MA approval process. The company will be notified on approval or disapproval by MHRA.
Just got this message from MHRA saying that CHM meeting is a close door meeting not available to public knowledge, So if they held the meeting on March 14 per the revised schedule on March, they may have already have render a verdict on DCVAX L. I hope we get MA approval by the first week of the May. GLTAL!
CEC 179545
Dear x
Thank you for your email and we apologise for delay.
We checked this with our Governance group and they have advised that unfortunately it wouldn’t be possible to listen in on Committee meetings.
Kind Regards
Peter
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC
The ultimate cancer treatment is DCVAX DIRECT, no mRNA sequencing, tumor sample cell culturing require, DCVAX DIRECT the ultimate treatment for all solid tumors!
After receiving this response from MHRA, I ask cordial Peter to update on this request. I am still waiting without any expectation. Peter gone silent. To me MHRA is trying to get this done asap without any leak on the MAA process for DCVAX:
From: MHRA Customer Services <MHRACustomerServices@mhra.gov.uk>
Subject: CEC 179545 - RE: Personalized Cancer Vaccine CHM meeting scheduled in March 2024
Date: March 12, 2024 at 12:09:36 AM HST
To:
Our Reference: CEC 179545
Dear
Thank you for your email.
We have directed your query to our Governance group for further input.
Should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.
Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
With regards
Peter
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU?Telephone 020 3080 6000
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC
Hey pal, Marzan.
I follow you from AMARIN board to here 2016 and ever since, I have been swapping Viscepa to DCVAX with no regret. I believe the judge knows that NWBO been a clandestine target for prolong short attach by these 7 defendants. I believe we have shown adequately that spoofing is still going on and the judge to tell them to stop the criminal activity is mood issue. What I want to see is the judge issuing preliminary injunction to prevent them from trading NWBO shares starting from 30 days from now. I believe this will start the short squeeze.
LOL, I feel your pain as well, but once approve MHRA MA, it will move. At this point I take solace in the fact that MA approval is a forgone conclusion which means no risk of failure of the drug trial, which is the biggest risk for bio tech investors. Now I am trying to figure out how fast and high it will go up so that I don't get short change. Be patient my friend longs.
Well, the management said in 10K they are too busy with MAA process for them to proceed with the signing the collaboration contract with BP. Then they said prior, these collaboration will be carried out after cementing the MAA process. Doesn't this sound like arbitrary and unilateral decision by the company then cooperative with the BP's. To me LP is giving time to a potential suitor that you should better your figures for the offer made. Just a thought.
I sent a email to MHRA about CHM meeting for DCVAX and got a reply saying that the letter were rerouted to the CHM responsible person. It's been two days and no response yet. I not counting on this anymore. Maybe there will be no CHM for DCVAX, may not required and directly to approval ?
It looks like KG, Citadel, took back 1/2 Billion donation to Harvard U. calling them snowflakes not too long ago. Is he getting ready for settlement money with NWBO for his portion? We will see soon.
If Ex and your ilk want to survive, come on out and fight and win the case. That's the only way. But did't you already admit that you spoof and made a little money? This amount to committing Seppuku. You sound like dead man talking. LOL.
Lol, there is no where to run or hide from this law suite! That's the beauty!
Either way Citadel, HF and you are in deep Shi$$t. There will be a multiple of copy cats out there chasing after you all soon after the outcome.
Looks like Commissioning of DCVAX-L as Human Medicine will be done on March 14, 2024 in lieu of March 20 or 21 as we were expecting. We will find out what the third party pundits think of DCVAX L paradigm shifting medical treatment for all cancer
tumors and infectious deceases on that day. I believe this is an open forum type meeting where the industry experts can earnestly express their concerns on safety and efficacy of the drug in review without reservation.
The CHM meeting date on March 2024 is shown as on March 14 2024. I wonder?
2024
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Type II Yellow Card data
PEAG now review applications for access to Type II Yellow Card data. The completed Type II Yellow Card data application form should be emailed directly to vigilanceservice@mhra.gov.uk.
Application Form (PDF, 173 KB, 10 pages)
Isotretinoin Expert Working Group
Terms of reference
The terms of reference for the IEWG are:
to evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on psychiatric effects suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
to evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on sexual disorders suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
to consider the impact of the available information on psychiatric effects and sexual disorders on the balance of benefits and risks of isotretinoin.
to consider what research could be undertaken to further elucidate any risks and long-term impact of psychiatric effects and sexual disorders and inform risk minimisation measures.
to make recommendations to the Commission on Human Medicines to improve the balance of benefits and risks for isotretinoin, to raise awareness of the associated risks and for further research to evaluate the risks.
Chair
Professor Angela Thomas OBE MB BS PhD FRCPE FRC Path
University of Edinburgh
Members
Professor Darren Ashcroft BPharm, MSc, PhD, FRPharmS Professor of Pharmacoepidemiology, Head, Drug Usage and Pharmacy Practice Group, University of Manchester
Professor Amanda Drake FRCPE Personal Chair of Epigenetics and Metabolism, Academic Director, Academic Foundation Programme, Associate Director, Edinburgh Clinical Academic Training Programme
Professor Nicol Ferrier BSc MB ChB MD FRCP FRCPsych Professor of Psychiatry and Honorary Consultant Psychiatrist, University of Newcastle
Dr Arianna Di Florio Clinical Senior Lecturer, Cardiff University Honorary Consultant Psychiatrist, Cardiff and Vale University Health Board, Adjunct Assistant Professor, University of North Carolina at Chapel Hill
Dr Clive Grattan BA MA MB BChir FRCP MD ILT Consultant Dermatologist, St John’s Institute of Dermatology, Guy’s Hospital, London
Professor David Gunnell MB ChB MRCGP PhD MSc FFPHM Professor of Epidemiology, University of Bristol
Professor Peter C Hindmarsh Professor of Paediatric Endocrinology, University College London
Dr Karen Miller BSc MBBS DRCOG DCH DFFP FRCGP
GP Partner, Adelaide Medical Centre, London
Professor Rod Mitchell Professor of Developmental Endocrinology, Honorary Consultant Paediatric Endocrinologist, UKRI Future Leaders Fellow/Academic Lead for Public Engagement MRC Centre for Reproductive Health, Queens Medical Research Institute, Edinburgh
Professor Gudrun Moore Professor of Clinical and Molecular Genetics, Genetics and Genomic Medicine, UCL Great Ormond Street Institute of Child Health
Mr Giangiacomo Ollandini FRCS MD Milton Keynes Hospital NHS Foundation Trust - Urology Urologist, Andrologist, MSc in andrological surgery and gender disorder
Ms Linda Pepper BA MA (Education) Independent Consultant: patient and public involvement in healthcare
Dr Amr Abdel Raheem MB BCh, MSc, DipSurg, PhD, FECSM, FEAA University College London Hospitals NHS Foundation Trust infertility & contraception, Peyronies Disease, Erectile Dysfunction and male Hypogonadism
Mrs Madeleine Wang BA (Hons) Lay Representative, Patient Advocate
Professor Allan Young Vice Dean, Academic Psychiatry (Interim), Director, Centre for Affective Disorders NIHR Senior Investigator, Academic Director, Psychological Medicine and Older Adults Clinical Academic Group, Immediate Past President of International Society for Affective Disorders, President British Association for Psychopharmacology, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London
Observers
National Institute for Health and Care Excellence (NICE)
NHS Improvement
The Care Quality Commission
Primary Care Dermatology Society (PCDS)
COVID-19 Therapeutics Expert Working Group
Remit
To advise on the safety and efficacy of candidate anti-viral agents, immune-based therapies and repurposed agents for the treatment and prevention of COVID-19 infection, based on available scientific data.
To review the robustness of the evidence of supporting agents used for the treatment of COVID-19 complications, including agents based on putative mechanisms, as currently available and based on emerging data.
To advise on strategies and study designs to collect efficacy and safety data including novel trial designs.
To advise on measures to minimise risks and optimise the benefit-risk balance of anti-viral agents, supportive therapies (e.g., corticosteroids, NSAIDS, chloroquine, immune modulators, etc) proposed for the treatment of COVID-19 infection and its complications.
To advise on the benefits and risk of concomitant medications (e.g., ACE inhibitors/ AT-II blockers or immunosuppressants).
To advise on measures to monitor safety and effectiveness of risk minimisation measures relating to these medicinal products.
To advise the Commission on Human Medicines.
Chair
Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London
Members
Professor Kenneth Baillie BSc(Hons) MBChB PhD FRCA FRCP FFICM
Professor of Experimental Medicine Roslin Institute, University of Edinburgh
Ms Susan Bradford Lay Representative
Professor David Dockrell MB BCh MD FRCPI FRCP (Glas) FACP Professor of Infection Medicine, University of Edinburgh
Professor Richard J C Gilson MD FRCP Professor of Sexual Health & HIV Medicine, Director of the UCL Centre for Clinical Research in Infection & Sexual Health & Deputy Director of the UCL Institute for Global Health
Sir Michael Jacobs Consultant & Hon. Senior Lecturer in Infectious Diseases Royal Free London NHS Foundation Trust
Professor Nigel Klein BSc MBBS MRCP PhD FRCPCH Consultant, Great Ormond Street Hospital for Children NHS Trust; Professor of Infectious Diseases and Microbiology, Institute of Child Health, UCL
Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath - Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals
Professor B Kevin Park BSc PhD FMedSci HonFRCP FBTS HonFBPhs Professor of Pharmacology, University of Liverpool
Professor Deenan Pillay Professor of Virology, UCL Pro-Vice-Provost International
Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the Centre for Drug Safety Science
Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA ,FRSC, MBPharmacolSoc Emerita Professor of Toxicology, University of Surrey Visiting Profesor of Toxicology, University of Hertfordshire
Observers
Professor Stuart Ralston MB ChB MD FRCP FMedSci FRSE FFPM (Hon) Professor of Rheumatology, University of Edinburgh, Western General Hospital, Edinburgh
Department of Health & Social Care
Public Health England
NHS England & NHS Improvement
National Institute for Health and Care Excellence (NICE)
COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group
Remit
Pre-deployment phase
To landscape the different healthcare datasets that are currently available in the UK to capture near real-time information on COVID-19 vaccine exposure and study endpoints relevant to vaccine safety and potential for disease enhancement (and effectiveness). This should take into account a range of potential scenarios for vaccine deployment (i.e. the point of administration and any prioritised/targeted immunisation), and should advise on the need for further data capture and linkage.
To advise on the most suitable study endpoints and design(s) to monitor COVID-19 vaccine safety, and potential for disease enhancement (and effectiveness).
To support engagement with UK institutions who may be planning/in a position to conduct COVID-19 vaccine safety studies. This is to encourage and facilitate studies that are complementary in terms of objective and design, to avoid duplication and to accommodate a suitable range of study endpoints and scenarios for vaccine deployment.
To advise on proposals for enhanced passive surveillance.
To advise on communications in support of the pharmacovigilance strategy.
Post-deployment phase
To advise on the emerging evidence from all data sources on the risks and benefits of vaccine(s) during the course of any COVID-19 immunisation campaign in the UK. This includes measures to minimise risks, and optimise the benefit-risk balance for individual vaccines, such as any new precautions or restrictions on use.
To advise on any communications to health professionals and the public.
To advise on measures to monitor impact/effectiveness of any additional risk minimisation.
Chair
Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals & Chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG) & Member of the Commission on Human Medicines (CHM)
Members
Professor Ian J Douglas BSc MSc PhD Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine & Member of the Pharmacovigilance Expert Advisory Group (PEAG)
Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London & Chair of the Infections Expert Advisory Group (IEAG) & Member of the Commission on Human Medicines (CHM)
Sir Michael Jacobs MA PhD MB BS FRCP FRCP Edin DTM&H Clinical Director of Infection, Royal Free London NHS Foundation Trust & Hon. Senior Lecturer, Liverpool School of Tropical Medicine
Professor Simon De Lusignan Professor of Primary Care and Clinical Informatics, University of Oxford
Professor Rupert Payne MB ChB PhD MRCGP FRCPE FBPhS FHEA Professor of Primary Care & Clinical Pharmacology, University of Exeter. Member of the Pharmacovigilance Expert Advisory Group (PEAG)
Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the Centre for Drug Safety Science
Professor Siobhan Quenby MBBS BSc MD FRCOG Professor of Obstetrics, Warwick University & Member of the Medicines for Women’s Health Expert Advisory Group (MWHEAG)
Professor Chris Robertson PhD MSc BSc Professor of Public Health Epidemiology, University of Strathclyde
Professor Calum Semple PhD FRCPCH FRCPE FHEA Professor of Outbreak Medicine University of Liverpool
Invited Experts
Professor Elizabeth Miller Department of Infectious Disease Epidemiology, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine
Professor Anthony Scott JCVI member, and Professor of vaccine epidemiology, Director HPRU in immunisation
Helen McDonald LSHTM Health Protection Research Unit
Jemma Walker LSHTM Health Protection Research Unit
Observers
Professor Liam Smeeth MBChB FRCGP FRCP MSc PhD FMedSci Professor of Clinical Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM) & MHRA, Non-Executive Director (Board)
Visiting Experts
Professor Andrew Pollard FRCPCH PhD FMedSci Chief Investigator of the Oxford ChAD vaccine
Professor of Paediatric Infection and Immunity, Director of Graduate Studies, Department of Paediatrics, Vice Master, St Cross College, University of Oxford & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)
Professor Robin Shattock Lead Scientist for the Imperial saRNA vaccine programme
Professor Sheena McCormack Clinical Project Lead at MRC CTU at UCL
COVID-19 Vaccines Benefit Risk Expert Working Group
Remit
To advise CHM on the quality, safety and efficacy of COVID-19 vaccines and on the balance of benefit and risks prior to authorisation.
To coordinate safety evaluation with the Clinical Trials, Biologicals and Vaccines Expert Advisory Group.
To report its conclusions and recommendations to the Commission on Human Medicines.
To advise on the emerging evidence from all data sources on the risks and benefits of vaccine(s) during the course of any COVID-19 immunisation campaign in the UK. This includes measures to minimise risks, and optimise the benefit-risk balance for individual vaccines, such as any new precautions or restrictions on use.
To advise on any communications to health professionals and the public.
To advise on measures to monitor impact/effectiveness of any additional risk minimisation.
Chair
Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci, David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the Centre for Drug Safety Science
Members
Professor Judith Breuer MD FRCPath FmedSci, Professor of Virology, University College London (UCL), Division of Infection and Immunity, London
Professor Gordon Dougan FRS, Department of Medicine, Cambridge Infectious Diseases, University of Cambridge
Mr V’Iain G Fenton-May BPharm MIPharm FRPharmS, Pharmaceutical Microbiologist
Professor Neil French MB ChB FRCP PhD, Head Department of Clinical Infection Microbiology and Immunology, Chair of Infectious Diseases & Global Health, Hon Consultant Infectious Diseases, Royal Liverpool & Broadgreen University Hospitals Trust
Professor David Goldblatt MB ChB FRCPCH FRCP PhD, Professor of Vaccinology and Immunology, Consultant in Paediatric Immunology, NIHR Senior Investigator, Great Ormond Street Hospital & University College London
Ms Susan Hunneyball BSc(Hons), Lay Member, Member of the Pharmacovigilance Expert Advisory Group (PEAG) and Advisory Board on the Registration of Homeopathic Products (ABRHP)
Professor Kimme Hyrich MD PhD FRCPC Professor of Epidemiology and Honorary, Consultant in Rheumatology, Centre for Musculoskeletal Research, Faculty of Biology Medicine and Health, University of Manchester and Kellgren Centre for Rheumatology, Manchester University NHS Foundation Trust
Sir Michael Jacobs MA PhD MB BS FRCP FRCP Edin DTM&H, Consultant in Infectious Diseases, Royal Free London NHS Foundation Trust; Hon. Senior Lecturer, University College London and Liverpool School of Tropical Medicine
Professor Helen J Lachmann MA MB BChir MD FRCP FRCPath, Professor of Medicine & Honorary Consultant Nephrologist, Clinical Director UCL Division of Medicine & Clinical Lead for National Amyloidosis Centre, University College London & Royal Free Hospital London NHS Foundation Trust & Vice-chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)
Professor Paul J Lehner PhD FRCP FMedSci FRS
Professor of Immunology and Medicine, Wellcome Trust Principal Research Fellow Honorary Consultant Infectious Diseases, Cambridge Institute of Therapeutic Immunology and Infectious Disease (CITIID), Jeffrey Cheah Biomedical Centre Cambridge Biomedical Campus
Mr Robert Lowe BPharm FRPharmS, Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England
Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath, Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals & Member of the Commission on Human Medicines (CHM) & Chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)
Professor Yvonne Perrie BSc Hons MRPharmS FAPS FSB PhD, Chair in Drug Delivery, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow. Scotland
Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA, FRSC, MBPharmacolSoc, Emerita Professor of Toxicology, University of Surrey, Visiting Professor of Toxicology, University of Hertfordshire and Member of the Commission on Human Medicines (CHM)
Dr Andrew Riordan MD FRCPCH DTM&H, Consultant in Paediatric Infectious Diseases and Immunology, Honorary Clinical Lecturer, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Liverpool
Professor Chris Robertson PhD MSc BSc, Professor of Public Health Epidemiology, University of Strathclyde
Professor Kevin M G Taylor BPharm PhD FRPharmS, Chair of the British Pharmacopoeia Commission and Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London
Dr Robin Thorpe BSc PhD FRCPath, Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC) & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)
Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA, Professor of Cellular Therapy; Medical Director Scottish National Blood Transfusion Service (SNBTS)
Professor Susannah Walsh BSc PhD MBA, Head of School, Professor of Pharmaceutical Microbiology, Pharmacy and Life Sciences, Robert Gordon University
Mrs Madeleine Wang BA (Hons), Lay Member & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)
Professor Christopher Weir BSc MSc PhD FRSS, Cstat Professor of Medical Statistics & Clinical Trials, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh & Member of Commission on Human Medicines (CHM)
Cancer Vaccines Expert Working Group
Remit
To advise CHM on the quality, safety and efficacy of candidate personalised cancer vaccines.
To advise CHM on the quality, non-clinical and clinical development of personalised cancer vaccines.
To advise on the measures to characterise the clinical effectiveness of personalised cancer vaccines in the clinical use setting.
To advise on the measures to monitor short-term & long-term safety and minimise the risks of personalised cancer vaccines.
To advise on healthcare practitioner and patient communications related to personalised cancer vaccines.
To advise on the regulatory nomenclature of cancer vaccines and immunotherapy.
Chair
Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci, David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the Centre for Drug Safety Science
Members
Dr Robert Andrews Senior Lecturer FHEA, Data Hub at Heath, Cardiff
Dr Colin Brown PhD FRCPath Consultant Clinical Scientist, Head of H&I Laboratory Colindale, NHS Blood and Transplant
Professor Robert Brown BSc PhD Professor of Translational Oncology, Department of Surgery & Cancer, Imperial College London
Dr Peter Buckle FRSPH, FIEHF, FIEA, C.ErgHF Principal Research Fellow, NIHR London In Vitro Diagnostics Co-operative Department of Surgery and Cancer, Faculty of Medicine, Imperial College London
Professor Tom Clutton-Brock MBE MB ChB FRCP FRCA Director, Medical Devices Testing and Evaluation Centre, Clinical Director, NIHR Trauma Management MedTech Cooperative, Chair, NICE Interventional Procedures Advisory Committee, Associate Medical Director, University Hospitals Birmingham NHS Foundation Trust, Professor of Anaesthesia & Intensive Care Medicine, University of Birmingham
Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education/Consultant Clinical Pharmacologist, University of Birmingham
Mrs Julia Cons Lay Representative
Professor Ann Daly BA PhD FBPhS Professor of Pharmacogenetics, Faculty of Medical Sciences, Newcastle University
Professor Jon Deeks PhD CStat Professor of Biostatistics Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham
Dr Brendan Fish BSc PhD Director of Biologics & RNA Centre of Excellence
Professor Eric Lim MB ChB MD MSc FRCS(C-Th) Consultant Thoracic Surgeon, Royal Brompton Hospital, Professor of Thoracic Surgery, Imperial College London
Mr Robert Lowe BPharm FRPharmS Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England
Dr David Millrine PhD Translational Immunology Team lead, CRUK Cancer Biomarker Centre, University of Manchester
Professor Christian Ottensmeier MD, PhD, FRCP. Professor of Molecular and Clinical Cancer Medicine, University of Liverpool
Professor Poulam Patel PhD, MBBS, FRCP Professor of Clinical Oncology, University of Nottingham
Professor Yvonne Perrie BSc PhD Professor in Drug Delivery within the Strathclyde Institute of Pharmacy and Biomedical Sciences
Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA, FRSC, MBPharmacolSoc Emerita Professor of Toxicology, University of Surrey, Visiting Professor of Toxicology, University of Hertfordshire
Professor Jacqui Shaw BSc PhD Group Leader and Professor of Translational Cancer Genetics, Leicester University
Professor James Spicer FRCP, PhD Professor of Experimental Cancer Medicine, King’s College London; Consultant in Medical Oncology, Guy’s & St Thomas’ NHS Foundation trust
Professor Nigel Stallard Professor of Medical Statistics, Deputy Director Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry
Professor Kevin M G Taylor BPharm PhD FRPharmS Emeritus Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London
Dr Robin Thorpe BSc PhD FRCPath Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)
Dr David Turner PhD FRCPath H&I Laboratory, Scottish National Blood Transfusion Service, Royal Infirmary of Edinburgh
Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy, Medical Director Scottish National Blood Transfusion Service
Professor Christopher Weir BSc MSc PhD FRSS Cstat Professor of Medical Statistics & Clinical Trials, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh
Professor Anthony Williams BSc MSc MRCP, FRCPath, PhD Professor of Translational Medicine and Honorary Consultant in Clinical Immunology and Allergy, University of Southampton, and University Hospital Southampton NHS Trust
Professor Christina Yap MSci PhD C. Stat Professor of Clinical Trial Biostatistics, Team Leader in Early Phase and Adaptive Trials Team, ICR-Clinical Trials and Statistics Unit, The Institute of Cancer Research [Cancer UK/ UK CI]
Professor Christopher Yau MA MEng DPhil Professor of Artificial Intelligence, Nuffield Department of Women’s & Reproductive Health, University of Oxford, and Health Data Research UK
Professor Ly-Mee Yu BSc MSc DPhil Professor of Clinical Trials and Biostatistics, Deputy Director Academic of Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford
Observers
Professor Peter Johnson National Clinical Director for Cancer, England
Dr Jayne Spink Prostate Cancer Research
Membership and Minutes for CHM and its expert advisory groups.
Cancer Vaccines Expert Working Group
Remit
To advise CHM on the quality, safety and efficacy of candidate personalised cancer vaccines.
To advise CHM on the quality, non-clinical and clinical development of personalised cancer vaccines.
To advise on the measures to characterise the clinical effectiveness of personalised cancer vaccines in the clinical use setting.
To advise on the measures to monitor short-term & long-term safety and minimise the risks of personalised cancer vaccines.
To advise on healthcare practitioner and patient communications related to personalised cancer vaccines.
To advise on the regulatory nomenclature of cancer vaccines and immunotherapy.
Chair
Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci, David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the Centre for Drug Safety Science
Members
Dr Robert Andrews Senior Lecturer FHEA, Data Hub at Heath, Cardiff
Dr Colin Brown PhD FRCPath Consultant Clinical Scientist, Head of H&I Laboratory Colindale, NHS Blood and Transplant
Professor Robert Brown BSc PhD Professor of Translational Oncology, Department of Surgery & Cancer, Imperial College London
Dr Peter Buckle FRSPH, FIEHF, FIEA, C.ErgHF Principal Research Fellow, NIHR London In Vitro Diagnostics Co-operative Department of Surgery and Cancer, Faculty of Medicine, Imperial College London
Professor Tom Clutton-Brock MBE MB ChB FRCP FRCA Director, Medical Devices Testing and Evaluation Centre, Clinical Director, NIHR Trauma Management MedTech Cooperative, Chair, NICE Interventional Procedures Advisory Committee, Associate Medical Director, University Hospitals Birmingham NHS Foundation Trust, Professor of Anaesthesia & Intensive Care Medicine, University of Birmingham
Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education/Consultant Clinical Pharmacologist, University of Birmingham
Mrs Julia Cons Lay Representative
Professor Ann Daly BA PhD FBPhS Professor of Pharmacogenetics, Faculty of Medical Sciences, Newcastle University
Professor Jon Deeks PhD CStat Professor of Biostatistics Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham
Dr Brendan Fish BSc PhD Director of Biologics & RNA Centre of Excellence
Professor Eric Lim MB ChB MD MSc FRCS(C-Th) Consultant Thoracic Surgeon, Royal Brompton Hospital, Professor of Thoracic Surgery, Imperial College London
Mr Robert Lowe BPharm FRPharmS Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England
Dr David Millrine PhD Translational Immunology Team lead, CRUK Cancer Biomarker Centre, University of Manchester
Professor Christian Ottensmeier MD, PhD, FRCP. Professor of Molecular and Clinical Cancer Medicine, University of Liverpool
Professor Poulam Patel PhD, MBBS, FRCP Professor of Clinical Oncology, University of Nottingham
Professor Yvonne Perrie BSc PhD Professor in Drug Delivery within the Strathclyde Institute of Pharmacy and Biomedical Sciences
Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA, FRSC, MBPharmacolSoc Emerita Professor of Toxicology, University of Surrey, Visiting Professor of Toxicology, University of Hertfordshire
Professor Jacqui Shaw BSc PhD Group Leader and Professor of Translational Cancer Genetics, Leicester University
Professor James Spicer FRCP, PhD Professor of Experimental Cancer Medicine, King’s College London; Consultant in Medical Oncology, Guy’s & St Thomas’ NHS Foundation trust
Professor Nigel Stallard Professor of Medical Statistics, Deputy Director Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry
Professor Kevin M G Taylor BPharm PhD FRPharmS Emeritus Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London
Dr Robin Thorpe BSc PhD FRCPath Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)
Dr David Turner PhD FRCPath H&I Laboratory, Scottish National Blood Transfusion Service, Royal Infirmary of Edinburgh
Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy, Medical Director Scottish National Blood Transfusion Service
Professor Christopher Weir BSc MSc PhD FRSS Cstat Professor of Medical Statistics & Clinical Trials, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh
Professor Anthony Williams BSc MSc MRCP, FRCPath, PhD Professor of Translational Medicine and Honorary Consultant in Clinical Immunology and Allergy, University of Southampton, and University Hospital Southampton NHS Trust
Professor Christina Yap MSci PhD C. Stat Professor of Clinical Trial Biostatistics, Team Leader in Early Phase and Adaptive Trials Team, ICR-Clinical Trials and Statistics Unit, The Institute of Cancer Research [Cancer UK/ UK CI]
Professor Christopher Yau MA MEng DPhil Professor of Artificial Intelligence, Nuffield Department of Women’s & Reproductive Health, University of Oxford, and Health Data Research UK
Professor Ly-Mee Yu BSc MSc DPhil Professor of Clinical Trials and Biostatistics, Deputy Director Academic of Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford
Observers
Professor Peter Johnson National Clinical Director for Cancer, England
Dr Jayne Spink Prostate Cancer Research
Seems like this is the last category listed on the CHM advisory membership addressing something like DCVX-L. Looking up!
If this CHM Meeting is set up on March 21 or 22 DCVX-L, MHRA would notify the company shortly requesting
for presentation at the meeting. This will in turn confirms that we are in fact being evaluated under the new expedited 150 day MA approval process. Also HMRA should be rendering their verdict on DVAX L approval by the latest May 20, 2024 in line with the 150 day timeline. I think this the inference thinking of those who's predicting 1st half of 2024 approval.
According to new MHRA MAA guide line, a high quality MAA will be evaluated within 150 days starting Jan. 2024 and list the MAA submittal deadline for CHM meeting which we have met for March CHM meeting by submitting before 25 Dec. 2024 deadline. So we may able to witness CHM meeting since this is open to public. So this March would be an important month for NWBO and us. Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances.
The MHRA will operate a 150-day Assessment route for high-quality marketing authorisation applications (MAAs).
For applications containing new active substances, submissions should be received by the following dates in order to align with the meeting dates of the Commission on Human Medicines (CHM).
The Marketing authorisation application dossier should be submitted through the MHRA Submissions portal on or before the deadline as detailed below:
CHM meeting Submission deadline
27 and 28 January 2023 01 November 2022
23 and 24 February 2023 28 November 2022
23 and 24 March 2023 26 December 2022
27 and 28 April 2023 30 January 2023
25 and 26 May 2023 27 February 2023
29 and 30 June 2023 03 April 2023
27 and 28 July 2023 01 May 2023
24 and 26 August 2023 29 May 2023
28 and 29 September 2023 03 July 2023
26 and 27 October 2023 31 July 2023
23 and 24 November 2023 28 August 2023
21 and 22 December 2023 25 September 2023
25 and 26 January 2024 30 October 2023
22 and 23 February 2024 27 November 2023
21 and 22 March 2024 25 December 2023
Sorry, my bad if that's the case.
As of Feb 15, 2024 MHRA performance data for clinical trials evaluation.
The latest MHRA performance data shows that clinical trials applications continue to be handled within target statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 26 days for initial assessments (within the statutory timescale of 30 days) and an average of 24 days for assessments of amendments (within the statutory timescale of 35 days).
The MHRA has now eliminated backlogs in processing clinical trial applications and embedded improvements into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
It looks like on average 50 days for complete review of new drug application under the new guide line. the March timeline looking very promising. UK.Gov
True, I just start posting 2 days ago but not a clown. On the contrary, I have been here since 2016 chasing the carrot that LP dangling with PFS result, data lock, Phase III results publish by prominent journal, MAA submission and now MAA cementing initiating Combo trial contract with BP. I kind a got tire of it chasing after all these carrots. For change for the better I am with all you are now waiting on MHRA decision not the company guidance event lines. Like I said, I was a silent majority visiting here time to time gathering information from well verse longs here and it has been very helpful. I didn't post until now bc people like you and S littering the MB along with the shorts with no value. Then you may ask why now, bc I am genuinely hopeful that we will get the approval soon from the RA and expressing my exuberance. Sorry if you don't like what you see here then change the channel - you don't have to be childish.
Look S
The phase III result is nothing secret or liable. Why not trumping this results. Have you seen anywhere they, the company, promoting this result. There is no real drug out there that truly treat GBM other than the poisoning cancer chemo therapy that nearly kills patiences. Didn't you see how Modena and Merck promoting mRNA Cancer Vaccine deal. Come on get with the program.
They don't even have a dedicated CFO at this point says a lot. I believe it's not a buy out but many major deals with BP which will make them sit back relax.
No comparison to DCVX but why the company is in radio silence mode. Why why why mmmmm.
I personally experienced this many times before and you are spot on. I hope take advantage of this knowledge this time to accumulate more shares during this process.
Agree, but the mystery is why LP is not shouting their DCVX to mass media especially when they need some operation fun urgently now.
Patenting requires search for prior art to insure that you are not duplicating someone else's work. If this is the case for all regions and countries then EU Comb paten would be good enough or why or should we have to pursue patens from other countries, like China ? I am just curious.