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I agree newman2021.
death of cancer cells pic.twitter.com/g4g3Jtnb3i
— Slava Bobrov (@slava__bobrov) July 19, 2024
The revolutionary DCVax-L vaccine has allowed GBM patient Jim Power to live a good life 10 years after his first brain surgery. I wish him at least ten more years of good fortune!
July 27, 2014 my Dad went in for his first Craniotomy only to be diagnosed with GBM.
— Kristyn Power, CFA (@KristynPower) July 28, 2024
At that time watching the 2024 Paris Olympics was a very longshot. I just asked him what he wanted to post “Made 10 years, looking for 10 more.” Sending all patients and families love. ❤️ pic.twitter.com/gk3EQG4zvN
This is him getting his sixth shot in the arm with Professor Ashkan at King’s College Hospital in May. We don’t know the vaccine works till it works of course ... but so far things look good.
— rj (@sharpie510) July 23, 2024
🙏
The DCVax® Platform
💪$nwbo #DCVax #Glioblastoma #GBM #HOPEhttps://t.co/98rnusvxd6 pic.twitter.com/b3KRJ3CIjj
I think Owain James is the patient.
A message from Owain’s family, thank you to everyone who has supported them. #fundsforowain pic.twitter.com/uyIBTMXkvN
— FundsForOwain (@FundsForOwain) June 29, 2024
Thanks ATLnsider.
Marnix Bosch will do the presentation.
17th July.
Exhibitor Showcases
We’re pleased to host a selection of exhibitor showcases throughout the conference in collaboration with our platinum and gold sponsors. These will be hosted in the Concert Hall during the Main Sessions.
Please do not miss out on the opportunity to hear about the latest news and innovations.
Wednesday
14:45 – 15:15 Northwest Biotherapeutics | DCVax®-L – Lessons from long-term survivors – Marnix Bosch
Pawel Kalinski MD, PhD
I’m so sorry to hear about the passing of Shenell Malloy.
She was such a beautiful soul and human. My prayers are with her family.
https://www.instagram.com/fightingpretty/p/C8F508nyVbz/
fightingpretty
4 days ago
It is #NationalCallYourDoctorDay and we’d like to take a moment of silence for Shenell Malloy.
She lived a remarkable life of strength and hope 🌟
It is with deep sorrow and profound respect that we remember and honor the life of Shenell Malloy, the fierce founder of Do Cancer, who passed away after a valiant battle with stage 4 glioblastoma. Shenell’s journey, marked by her diagnosis in February 2019, is a testament to the power of resilience, love, and an unwavering spirit. She lived five years beyond her expected prognosis, cherishing each day with a zest for life that inspired everyone around her.
Her perspective as a five-year survivor continues to resonate deeply, not just for those battling cancer, but for anyone striving to live a wholehearted and meaningful life. In her own words, shared in her Survivor Story, Shenell imparted a wisdom that will forever guide us:
“For the first time in my life, I am truly awake, living a meaningful, fulfilled life. Every part of me is conscious and present.
The greatest gift cancer gave me was the opportunity to transform into the strongest and best version of myself. Cancer taught me that we need to give pain the space to breathe in order to heal. Every painful, heart-wrenching situation gives us perspective and reminds us how we only have this one life to live. It gives us an opportunity to grow and become stronger. It has become a gift that I treasure every day—a gift that I hope to spread to others.”
Her legacy continues to support thousands of people across the globe seeking hope and guidance on their cancer journeys. Shenell truly believed that every day is a gift. She was given 2,000 more days than the statistics predicted, and each one of those days was lived beautifully and with purpose. We will forever cherish her spirit and the immense impact she made on so many lives.
Rest in peace, Shenell Malloy. You were truly Fighting Pretty. Your legacy of strength, compassion, and hope will continue to inspire and uplift us all.
— Tejas Kulkarni (@tejasdkulkarni) June 15, 2024
I am currently holding my dad's cryopreserved brain tumor samples in hopes of creating a personalized vaccine for immunotherapy. However, there are some critical and time-sensitive questions in the attached post: https://t.co/3lxkUruGRe
— Tejas Kulkarni (@tejasdkulkarni) June 15, 2024
This is time-sensitive so would appreciate… pic.twitter.com/Jxd52m3UlW
15th June 2024
09:30 - 10:20 AM
NOVEL RESEARCH IN THE NEUROSCIENCES: DEVELOPING A VACCINATION FOR GBM.
Speaker: Professor Keyoumars Ashkan
Gainsford Lecture Theatre.
Westen Education Centre
KCL Denmark Hill Campus
London.
26th June
🧠🧬💉This month we’re thrilled to welcome Prof. Keyoumars Ashkan from @KingsNeuro who will be talking us through Glioblastoma
— Brain School (@BrainSchool101) June 3, 2024
research!
🔬 Not an event to miss! We cannot wait!
🥳 As always, catch up drinks afterwards!
⏰ Wed 26th June, 7:00pm
🗺️ @RCSnews pic.twitter.com/DlT379wC7b
🔊 Speaker Announcement!
— KCL Neurosurgery Society (@KCLneurosurgery) May 19, 2024
We are pleased to announce the next speaker for our upcoming 2024 Conference 'Landmarks in Neurosurgery'!
Professor Keyoumars Ashkan is a leading neurosurgery specialist and works as the lead for functional and oncological neurosurgery at KCH!! 🧠🧠🧠 pic.twitter.com/XBQDgP17JF
Hey Adam, I wouldn't order anything at the snack bar. LOL
Not sure who deserves credit for this, but enjoy! #ASCO24 pic.twitter.com/eoRrA3S4rk
— Deborah Doroshow (@DDoroshow) June 2, 2024
Professor Keyoumars Ashkan
Consultation fees.
New appointment: £299.
Follow-up appointment:£247.
https://www.hcahealthcare.co.uk/finder/specialists/professor-keyoumars-ashkan
#ASCO24 pic.twitter.com/GTGYg7eYcx
— Dr. Nagla Abdel Karim (@NaglaAKarimMD) June 1, 2024
May 29
Nemesis18:
I my self have lived, 9 years after being diagnosed with GBM4, with no vaccine and just 6 weeks of standard adjuvant STUPP Protocol. With the cancer, which no scan has ever seen, apparently disappearing like a fart in the wind.
"I stopped all cancer related treatment & oral medication after just 6 weeks of chemo radio.
There was to be a follow on longer course of Temozolomide, but as I had never had a status MRI post craniotomy, nor before or during chemo radio, I demanded one as a precondition of me starting the 2nd phase of scheduled Chemo treatment.
That impromptu scan show absolutely ZERO evidence of cancer, which has remained the case for nine years ( even from the point of admittance to Kings in late February 2015.
I was treated for a stated brain abscess derived from a long standing rear upper molar infection, and I was discharged with a clean bill of health after 5 weeks as an inpatient."
Also the MHRA will not start reviewing the provided answers to the RFI until 60 days have passed even if the answers are in 2 weeks after the RFI has been sent. So 210 days
Phase II assessment will begin on receipt of the applicant’s responses. Based on the assessment, the MHRA will provide an opinion on approvability of the product by day 150, and if positive, will grant the MA.
Calendar days.
I don't believe that March 7th marked the end of the phase1 assessment process
It seems logical that the 150-day assessment period began on January 24, 2024, when the initial validation was confirmed. The March 7, 2024, confirmation likely served as an additional administrative check within the ongoing Phase 1 review process to ensure all documentation was in place and that the application was qualified for the 150-day assessment route.
StonkMaster,
I believe the 150-day assessment begane on Jan.24
IMO, it doesn't make sense to suggest that the 150-day assessment would begin on March 7, given that the standard process typically takes 210 days. Starting the rapid assessment 43 days after the validation confirmation would unnecessarily delay the process. It is logical to conclude that the 150-day assessment began on January 24, when the MAA initially passed validation.
CHATgpt:
The 150-day assessment route for Northwest Biotherapeutics' Marketing Authorization Application (MAA) for DCVax-L would start after the application passes validation. According to the information you provided:
- The MAA was filed on December 20, 2023.
- The company received notification on January 24, 2024, that the MAA had passed validation.
- On March 7, 2024, the company received confirmation of this validation.
The critical date here is January 24, 2024, when the company was first notified that the MAA had passed validation. This is typically when the regulatory review period, including any expedited assessment routes like the 150-day assessment, would begin. Therefore, the 150-day assessment route would start from January 24, 2024.
May 9, 2024
Les Goldman says "they are on track for accelerated approval (150- day assessment)" witch is new information.
We know that Northwest Biotherapeutics has requested the MHRA to allow the 150-day assessment route.
December 21, 2023
The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM). The application also requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.
“The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.
The criteria for qualifying for the 150-day assessment route in the UK are designed to ensure that the applications submitted to the MHRA meet specific standards of quality, safety, and efficacy. Here are some key criteria that pharmaceutical companies typically need to fulfill in order to qualify for this expedited review route:
1. **Comprehensive Data:** Applicants must provide a thorough and well-documented set of data on the quality, safety, and efficacy of the drug. This includes results from preclinical studies, clinical trials, manufacturing processes, and stability testing.
2. **Adherence to Good Manufacturing Practices (GMP):** The drug manufacturing facilities must adhere to Good Manufacturing Practices to ensure the quality and consistency of the product. The MHRA may conduct inspections to verify compliance with GMP standards.
3. **Compliance with Regulatory Guidelines:** The MA application should demonstrate compliance with relevant regulatory guidelines and requirements set forth by the MHRA and the European Medicines Agency (EMA), where applicable. This includes submitting all necessary documentation and following standardized procedures.
4. **Innovative or High Medical Need:** Drugs that offer significant therapeutic benefits for patients or address unmet medical needs are often prioritized for the 150-day assessment route. Innovative therapies or those targeting rare diseases may qualify for expedited review.
5. **Early Engagement with the MHRA:** It is advisable for applicants to engage with the MHRA early in the drug development process to discuss regulatory requirements, potential challenges, and any specific considerations for the application. This proactive approach can help streamline the review process.
6. **Risk Management Plan:** The application should include a comprehensive risk management plan to identify, evaluate, and mitigate potential risks associated with the drug, including pharmacovigilance strategies for monitoring safety post-approval.
7. **Benefit-Risk Assessment:** The applicant must provide a detailed benefit-risk assessment that weighs the therapeutic benefits of the drug against potential risks to patient safety. This assessment is crucial for the MHRA to evaluate the overall suitability of the drug for marketing authorization.
By meeting these criteria and submitting a high-quality MA application that aligns with the requirements set by the MHRA, pharmaceutical companies can increase their chances of qualifying for the 150-day assessment route and benefit from the expedited regulatory review process. This pathway aims to facilitate timely access to safe and effective medicines for patients while upholding rigorous regulatory standards.
The timeline for receiving confirmation that your Marketing Authorization Application (MAA) qualifies for the 150-day assessment route after submission to the Medicines and Healthcare products Regulatory Agency (MHRA) can vary depending on various factors. However, in general, the process typically unfolds as follows:
1. **Validation of MAA:** Upon submission of the MAA to the MHRA, the initial step is the validation process. During validation, the MHRA reviews the application to ensure that it contains all the necessary information and documentation required for assessment. This step typically aims to confirm that the application is complete and meets the basic regulatory requirements.
2. **Notification of Validation:** Once the validation process is complete, the MHRA will notify the applicant that the MAA has been validated. This notification typically confirms that the application has met the initial validation requirements and is proceeding to the next stage of assessment.
3. **Qualification for the 150-Day Assessment Route:** Following validation, the MHRA will then assess the application to determine if it qualifies for the 150-day assessment route. This assessment involves evaluating whether the application meets the specific criteria for expedited review under the 150-day pathway, as discussed in the previous responses.
4. **Confirmation of Qualification:** If the MAA meets the criteria for the 150-day assessment route, the MHRA will inform the applicant that their application has been qualified for expedited review. This notification typically confirms that the application will be subject to the accelerated 150-day timeline for regulatory assessment.
The time between the initial validation of the MAA and confirmation of qualification for the 150-day assessment route can vary, but applicants can generally expect to receive communication from the MHRA within a few weeks to a couple of months, depending on the complexity of the application and the workload of the regulatory authority.
It is important for applicants to engage proactively with the MHRA during the submission process, seek clarification on any requirements or issues that may arise during validation, and maintain open communication to ensure a smooth transition to the expedited review pathway if the application qualifies for the 150-day assessment route.
Overall, while the specific timing of notifications may vary, the MHRA strives to provide timely and transparent communication throughout the regulatory review process to support efficient evaluation of MA applications and expedite access to new medicines for patients in the UK.
Children and teenagers could benefit after a new targeted combination treatment for a rare, aggressive form of brain cancer was recommended today.
— NICE (@NICEComms) April 24, 2024
Find out more about how dabrafenib with trametinib works: https://t.co/LCkav3pgIP#NICENews pic.twitter.com/BKvjuKcVdo
TODAY MAY 22
7-8 a.m.
Join via ZOOM
Meeting ID: 913 1277 5742
Tomorrow we are honored to host @EKNduom from @EmoryNeurosurg for #Neurosurgery #GrandRounds. Esteemed surgeon, scientist, #Advocate, and leader @CNS_Update, we are excited for his talk "New Approaches to Immune Therapy for #Glioblastoma: Lessons Learned". @GWSMHS #CancerMoonshot pic.twitter.com/pnFlB1j2fI
— George Washington Neurosurgery (@GWnsgy) May 21, 2024
President Biden has appointed Edjah K. Nduom, MD, to the National Cancer Advisory Board. This board plays a crucial role in advising the director of the National Cancer Institute on setting the direction for the national cancer research program.
At the tumor session with Dr. Liau and Dr. Lim! #AANS2024 @MichaelLimMD @UCLANsgy @IsaacYangMD @AANSNeuro @StanfordNsurg #WhatMatters2Me pic.twitter.com/h5mFIOSmGc
— The Yang Lab (@TheYangLab1) May 5, 2024
AANS2024 Chicago
Monday, May 6, 2024
11:06 AM – 11:26 AM CT
Location: S503ab
Linda Liau – Immunotherapy.
Congratulations to the stellar lineup of UCLA #Neurosurgery Faculty & Residents who are scheduled at the @AANSNeuro Annual Meeting this weekend! Schedule: https://t.co/y6CRiQe2fi@ausaf @geoffreycolbymd @SpineNeuro @inspired_brain @IsaacYangMD @ShivaniBaisi_MD @brainbro #AANS2024 pic.twitter.com/oQ8oHKHmyz
— UCLA Neurosurgery 🧠 (@UCLANsgy) May 1, 2024
FORM 10-K/A (Amendment No. 1) filed April 29: https://www.otcmarkets.com/filing/html?id=17489512&guid=d5Q-kqGyIgi7B3h
Last Friday, we were honored to have Dr. Linda Liau as our 42nd Annual J. Jay Keegan Lecturer. It was an extraordinary afternoon for our residents with a phenomenal presentation and dinner to follow. We are so indebted to Dr. Liau for her time here in #Omaha. @unmc @UCLANsgy pic.twitter.com/tqb36hpn6w
— UNMC Department of Neurosurgery (@UNMC_NeuroSurg) April 22, 2024
I'm still waiting to hear back on my FOIR for the March CHM meeting minutes. Should be by end of this week. Don't anticipate it will reveal much but we'll see.
The role of CHM is to provide the Licensing Authority with independent advice on the safety, efficacy and quality of medicinal products. It is the role of the Licensing Authority, on behalf of Secretary of State, to take a final decision to grant a marketing authorisation for a medicinal product. Following this decision a Public Assessment Report (PAR), containing the non-confidential parts of the MHRA’s assessment, is published on the MHRA website.
CHM discuss high number of products and applications at each of their meetings. Information withheld under Section 43 of the Freedom of Information (FOI) Act is withheld because the information is either (1) a trade secret; (2) would likely prejudice the commercial interests of any legal person. There is no time limit after which this information can be released, moreover, any consideration of its release would be made by consideration of whether the public interest in releasing outweighs any commercial harm that could be caused by its release. More information on Section 43 of the FOI Act is available from the Information Commissioner’s Office.
Guidance
150-day assessment for national applications for medicines
if your idiotic analysis is correct, we have well passed the 80 day phase 1 assessment!
Calendar days and not business (working) days.
From MHRA:
Guidance
International Recognition Procedure - supplementary information
Updated 8 April 2024
IRP routes are substantially shorter than the 150 to 210 calendar day timetable for a national MA application.
Ex,
EAMS medicines are provided free of charge to the NHS (National Health Service),‘Specials’ may be provided free of charge or charged (generating revenue).
UK Early Access Programs: EAMS and ‘Specials’
Published 05th February 2024
https://www.dlrcgroup.com/uk-early-access-programs-eams-and-specials/
In 2017, this combination was adopted in the UK compassionate use program.
From inspire.com:
More about DC-Vax
Mary Ann Laubaucher(Sumomof2)
Today • 2:06 AM
I wonder if anyone has participated in the DC-Vax trial? We tried to get my son in but didn’t have adequate tissue to proceed.
I spoke with DellAnn Elliot Mydland and hope it is Ok to post here the link she is asking people to complete if they want to comment as this treatment as the data is being presented to the FDA: https://app.hatchbuck.com/OnlineForm/93633623355.
This community has the most impact when we speak up and raise awareness about our experiences with treatment options ( or the lack thereof).
If you tried to access the trials or were involved you especially have information that needs to be heard.
Thank you
Mary Ann
I hope Dr.Mulholland’s next immunotherapy trial for people with glioblastoma (this summer?) is a combo trial with DCVax-L.
Thank you @Siobhain_Mc for campaigning on this issue. It would be amazing to get Dr Mulholland’s #immunotherapy trial for people with #glioblastoma up and running this summer. We’re with you! https://t.co/YWoEuSQ1q9
— The National Brain Appeal (@BrainAppeal) April 3, 2024
Diagnosed with a glioblastoma, Matthew is raising funds to pay for DC Vax-L treatment, which has the potential to extend his life, but is not available on the NHS. Access to new and better treatments - #ItsANoBrainer. Sign our open letter today: https://t.co/yvQSBzL5ta pic.twitter.com/oT4Dz7YB1v
— The Brain Tumour Charity (@BrainTumourOrg) March 25, 2024
Interesting Gofundme story.
Bo’s Brain Cancer Treatment.
2 days ago.
Hi, everyone! I’m starting this Go Fund Me in hopes of helping my dad, Robert “Bo” Sexton, and raise funds for his journey on becoming brain cancer-free.
My dad is currently undergoing an alternative brain cancer treatment in London, called DCVax, which is made by Northwest Biotherapeutics. DCVax is a personalized vaccine, given in a series of injections, that uses the patient’s own tumor tissue and dendritic cells to attack the cancer. Over the course of the next 18 months, he will travel back and forth to London for treatment, which is costly in itself, but the cost of manufacturing and administering the vaccine is well over $200,000.
He wasn’t too keen on the idea of seeking help from family, friends, peers, and possible strangers, but as his son, I think it’s important to share his story and help him in any way that I can. I consider my dad to be a very generous and giving person, always helping people in need. Whether he’s buying food for a stranger, donating to a cause, raising money for others, or attempting to donate his kidney to a friend, he always steps up to help people and I’m hoping we can do the same for him.
How we got here:
In April of 2022, my dad was helping his wife move her late mother’s belongings when he had a “fortunate” fall. He went to the emergency room, received 24 stitches in his head, and underwent a CT scan, where the doctors quickly discovered a brain tumor in his frontal lobe.
On July 22nd, 2022, he had a craniotomy procedure at UNC Chapel Hill to extract the tumor.
Due to our family’s medical history and having seen loved ones go through chemotherapy and radiation for brain tumors, my dad was hesitant when it came to traditional cancer treatments. Understandably so, he wanted to explore alternative treatment options that were more forgiving on the body. As a precaution, an alternative treatment plan was put into place before his craniotomy. If the tumor was determined to be cancerous, the hospital was to move forward with this alternate plan, which essentially consisted of preserving the tumor in sub-zero temperatures and sending it to a company called, Northwest Biotherapeutics (NW Bio).
His biopsy results came back a few weeks later, where we learned he had a Grade 3 Oligodendroglioma, which is the highest grade for this type of cancerous brain tumor.
Upon diagnosis, the pathologist informed us that they weren’t able to preserve enough of the tumor needed for the alternative treatment plan. We were then told that he had 3 months to live if he didn’t start chemotherapy and radiation treatment immediately.
My dad was adamant about the alternative treatment plan, so he took a chance and waited for the tumor to grow back in order to start the process all over again.
He had a second craniotomy on November 2nd, 2023 at the Jacksonville Mayo Clinic to extract the regrown tumor, which was a success. The doctors were able to preserve the tumor and send it off to NW Bio in the UK.
The road ahead:
He started his treatment with NW Bio in February 2024. The daunting procedure began with an apheresis at Kings College where his blood is run through a machine for four hours and his cells are collected and subsequently cultured into the dendritic cells. The pre-procedure testing required him to be in London for two weeks. The vaccine is currently being manufactured, and soon he will return to London for three weeks to receive his first three injections. He will need to have a friend or family member accompany him as post surgical healing is still occurring and he is in unfamiliar territory.
He will return to London several more times to receive the full series of vaccines, depending on how many are able to be made from his tumor tissue. This will entail six round trip airfares for two people and a place to stay each time.
He is feeling incredibly optimistic after hearing the survival stories of the DCVax patients who have received this treatment. A story was recently posted about a person who had a 14 cm tumor and is doing well after having received a scan after 6 DCVax injections.
On behalf of my father, our family, and his friends and neighbors who love and appreciate him and all that he does for others, we would be grateful for any donation that you are able to make, large or small, to enable him to have a chance to survive this dreaded disease. If you knew him, you would love him like we all do. From all of us, we send our love and gratitude for reading about his brain cancer journey, and quest to obtain the long and healthy survival via the promising DCVax personalized dendritic cell vaccine therapy. God bless you.
Updates:
11hours ago:
Owain James
Owain had a successful surgery in Turkey, the removed all visible tumour which is AMAZING! and we now have more fresh frozen tumour so hope to get some more DCVax-L. 2 Ommaya's have been placed in Owain's head; one where the original tumour was (right frontal lobe) and another where the recurrence was (left ventrical). See photos
Owain James
Despite the last positive 15 months, we are unfortunately facing a set back. Owain has got recurrence in the left ventricle and the options offered by the NHS are not good enough, so we have decided to travel to Turkey for surgery and then onto Germany for Oncolytic Virus Treatment. I know we say it everytime but we honestly are so grateful for the donations provided because without that, we would be stuck with terrible options. As you can see below, Owain is still extremely well in himself & full of energy. More updates to follow.
Wow.
Reality check. They make at most 3 years worth of doses. They may not even be able to manufacture any but currently still charge the patient.
But who cares about reality when it is better to keep head in the sand. (Ex)
"First DCVax-L vaccine!
In total 22 vaccines have been made with my own tumour and white blood cells.
This is the future of cancer treatment, immunotherapy! "
Smokey, I wish you a full recovery! Stay strong and never give up!