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From Maria Quiban's instagram:
May 31
mariasearth
Must watch!
I’m really proud of this story. On this last day of May, being able to tell a very important story about an extraordinary #AAPI and bring more #braincancerawareness feels so healing. Please take the time to watch this and share too. It heals my heart and leaves me so encouraged and inspired. You will be too after hearing Dr. Linda Liau’s story!
When faced with her husband Sean Whitesell’s terminal diagnosis, FOX LA’s morning meteorologist Maria Quiban Whitesell found herself lost. While having to put a smile on her face every day in front of millions on LA’s popular morning show, Good Day LA, no one had a clue the kind of personal toll she was taking on at home. How does one face something like this? Especially in public. From having to explain the trauma to their young son, to responding to inappropriate questions, and dealing with the day-to-day through her husband’s harrowing treatments, death and life after, Maria was caught unprepared.
After dealing with her own grief, Maria now offers the book she wishes she had when Sean was diagnosed, for anyone to deal with any loss.
In her forthcoming book, YOU CAN’T DO IT ALONE: A Widow’s Journey Through Loss, Grief, and Life After, Maria teams up with licensed clinical social worker Lauren Schneider to provide readers with a roadmap for dealing with illness, death, and grief.
https://www.mariaquiban.com/my-writings/
Recruiting, recruiting, recruiting...
Mike Scott
Chief Operating Officer at Advent Bioservices
42 minutes ago.
Would you like an opportunity to work with a vibrant team in the area of cell therapy? Advent Bioservices is recruiting within several areas of the company. We are particularly keen to receive expressions of interest from clinical or research scientists with experience in cell culture.
Please view our website for details (www.adventbio.uk) or get in touch with our HR department https://lnkd.in/dARX7QzV
Cell Therapy Unit (CTU) Quality Director at King’s College Hospital (NHS Foundation Trust), London, UK. Ensuring working practice of 5 functional groups in the Cell Therapy Unit facility complies with MHRA, HTA and JACIE regulations. Responsible for the CTU Quality Management System. Responsible Person under a Specials and MIA(IMP) MHRA licence for an ATMP manufacturing group. Person Designated under an HTA human application licence.
branster,
Northwest Biotherapeutics is the only TITANIUM SPONSOR.
P.12 https://www.abta.org/wp-content/uploads/2021/09/2021-ABTA-NC-ProgramBooklet_Final.pdf
Nicomac Europe?
branster,
Final ABTA National Conference program is online today.
Linda Powers will not be presenting during the program.
P.14
Northwest Biotherapeutics is honored to participate in the American Brain Tumor Association's 2021 National Conference and invites you to visit our website for further information about our DCVax® Personalized Immune Therapies.
Visit us on the web at www.nwbio.com.
https://www.abta.org/wp-content/uploads/2021/09/2021-ABTA-NC-ProgramBooklet_Final.pdf
marzan,
I hope certification on or before September 14. (90 working days+ weekends+ 2 holidays (IMO) since the application was filed May 7, 2021)
Without a doubt, this will be an important milestone in the pathway to approval of DCVax-L.
Navigating regulations: novel cell therapy platforms and their path to clinical manufacturing
Cell & Gene Therapy Insights 2021; 7(5), 831–845
10.18609/cgti.2021.083
PUBLISHED: 11 AUGUST 2021
EXPERT ROUNDTABLE DISCUSSION.
Nina Bauer
Moderator
Head of Commercial, Gene Editing and Novel Modalities, Merck KGaA
Natika Calhoun
Senior Regulatory Consultant, Merck KGaA
She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections.
Anthony Davies
Founder and CEO, Dark Horse Consulting
Matt Muldoon
Senior Director Supplier Management, Allogene Therapeutics
(NB): A very broad question that essentially goes back to the overall regulatory environment – do you think that international harmonization of requirements between various regulatory agencies is a strong trend, and would such harmonization be more viable in specific disease areas? Anthony, any thoughts on international harmonization?
AD: We recently hired Don Fink from the FDA, and in the last 5 or 10 years he has been involved in a lot of harmonization discussions between the FDA and other regulators. We also have a lot of clients for whom we often take the US material to the MHRA, and we take the EMA trials to the PMDA in Japan.
It is a strong trend, and it is increasing. There are great things around the world, like the EudraLex and the International Organization for Standardization. It is increasingly international, and I think this is the way it is going to go.
Especially with the COVID vaccine situation. It is kind of nuts to have the MHRA approve a vaccine first, out there in London, then the FDA with a very fast second, and the EMA just struggling, frankly. There is no need for that, and I think things like the pandemic will just reinforce that trend. These products are either gene therapies like the AstraZeneca and J&J vaccines, or basically a gene therapy, like Pfizer and Moderna. I think that will reinforce the trend. I would say it is a strong yes to the question.
NC: I echo the strong yes.
The good news is that as our clients are submitting their BLAs, or getting new products that they want to get approved; the agencies are asking us first for our inspection reports. They want to see which agencies have inspected the site, referring to our viral vector manufacturing facility. The first question, for example if we have had the FDA come, is can we see your inspection report? Other agencies are definitely looking at those and making acceptances without necessarily coming to do an on-site inspection themselves.
I will also bring up COVID. In 2020 we had several inspections from different agencies planned. Of course, restrictions for travel, for coming on-site, for the safety of our operations, and having a 2-week quarantine for regulators to come from another country and sit in a hotel for weeks before coming on-site, just made everything entirely unfeasible.
They looked at what the other agencies had reported on before, and we were able to move forward, or have extensions, and so on. That was inter-agency, and is a direct benefit of the harmonization that is happening.
MM: Maybe it goes without saying, but obviously manufacturers clearly benefit from that harmonization. As much as possible, trying to follow a single set of clear guidance is an extreme advantage, especially as some of the players coming up in this space are smaller companies, and quite frankly don’t have the resources to look at regulatory guidance from many different places.
As much as that industry trend continues, it significantly helps the industry as a whole to push these therapies from the clinic to a commercial setting.
ATLnsider,
Thank you!
Some personal information about Linda Powers and her father was published in the Brain Tumour Magazine: World Edition 2020/2021.
Published on Oct 29, 2020
Linda Powers
Linda Powers is the CEO of Northwest Biotherapeutics. She gave a very personal account from an industry perspective as well as someone whose family had been touched by cancer.
Linda has lost many family members to cancer, including her father to glioblastoma. As her father’s advocate, she tried to help him get into a number of clinical trials and all of those efforts failed. She and her family experienced firsthand how difficult it can be for patients to enroll in clinical trials – especially older patients. They had also sought off-label access to temozolomide (not yet approved for brain cancer, then), initially failing but later obtained by travelling across the country..
As CEO of Northwest Biotherapeutics, Linda has also been on the other side of the table working to bring a new therapy through to late stage clinical development, and finding that one of the key difficulties is achieving the necessary patient enrollment. Linda also touched on some of the other significant hurdles which Northwest has had to negotiate to this point, including financial and regulatory challenges.
Outside of their current trial for a dendritic cell immunotherapy, Northwest Biotherapeutics has treated over 170 glioblastoma patients, and additional non-glioblastoma patients, under compassionate use. Linda believes that patients need more say in decision making, and more access to new treatments through compassionate use. Linda explained that Northwest Biotherapeutics collects all the data from their compassionate use patients. Patient groups can help enormously by increasing contributions of compassionate use data to data registries.
sharpie510,
thanks for sharing the patent news.
and Marvin Bergsneider about Linda Liau:
……Linda, i think, is far more successful….
The full agenda for the 3rd Glioblastoma Drug Development Summit has officially been released!
3rd annual Glioblastoma Drug Development Summit
January 18-20, 2022
Boston, MA
Conference Day Two Thursday, January 20
Optimizing Immunotherapies for GBM Drug Development
Marnix Bosch
CTO
Northwest Biotherapeutics
11.40 am Immunotherapy of Brain Cancer: Past, Present and Future.
• Challenges of designing & evaluating clinical trials for
immunotherapies in the GBM field.
• Strategies to sensitize glioblastoma to immune therapies.
• Exploring immune therapy resistance in glioblastoma.
https://glioblastoma-drugdevelopment.com/whats-on/speakers/?utm_source=internal&utm_medium=email&utm_campaign=launch&utm_content=primary/em-1/ev-22295
WEBINAR: I Had Brain Surgery, What's Next?
Linda Liau
August 26
ae kusterer,
Information about the Phase 3 trial for MDNA55 and the use of an ECA was first posted on ihub November 9, 2020.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159379704
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159380673
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160124042
That new?
The long-term data analysis (last updated in July 2011) showed that 33.0% of patients had reached or exceeded a median survival of 48.0 months and 27.0% had reached or exceeded a median survival of 72.0 months. By year 2013, two (n D2) of the Phase I/II clinical trial patients were still alive reaching a sur-vival of more than 10.0 years.
https://www.researchgate.net/publication/263708665_DCVaxR-L-Developed_by_Northwest_Biotherapeutics
fun fact NWBO, the initiator of the publication, is not the investigator Dr Liau is.
So if the trial would have failed she would no doubt publish about it in 3 or 4 years from now on a sunny Sunday afternoon. This has happened over and over with other trials
Resident Research Day Guest Speaker: Dr. Linda Liau
Professor and W. Eugene Stern Chair, Neurosurgery Department
Director, UCLA Brain Tumor SPORE
David Geffen School of Medicine at UCLA
"Immunotherapy in Brain Tumors: New Concepts"
CaptainObvious,
Not NWBO’s equipment but rather property of the Royal Free Hospital Centre for Cell, Gene and Tissue Therapeutics in London, IMO.
From LinkedIn (2017)
Advent Bioservices are a contract bioservices organisation providing GMP manufacturing services for a variety of ATMPs and related products, process development (PD) and ancillary services.
Advent’s head office is in London, we have lab facilities at the Royal Free Hospital Centre for Cell, Gene and Tissue Therapeutics and a state-of-the-art manufacturing facility in South Cambridgeshire. Phase 1 of the new facility in Cambridgeshire, is due to be licensed and operational from Q1 2018 and includes two completed suites (185m2 i.a. each) comprising B, C and PD/QC labs, offices and storage space. The facility has infrastructure in situ and capacity for 7,566m2 additional development.
flipper44,
ABTA : August 10
branster
Tuesday, 08/10/21 09:36:35 PM
Re: None
Post # of 396679
American Brain Tumor Email about NWBO I sent an email to them early today, below is what I ask and the response: I will be posting on Twitter as well.
Dear xxxxx,
Thank you for your interest in our upcoming National Conference. Northwest Biotherapeutics will have a brief session during the event titled "Accelerating the Pathways for New Treatments". This will occur on Saturday, September 11 at 12pm CT during the lunch break.
Please let me know if you have any questions. We hope that you are able to attend and gain benefit from the program.
Wishing you the best,
Ambreen
- How did we do? Take our 2-minute CareLine Survey
From: xxxxxxxxxxxxxxxxxxxxxxxxxx
Sent: Tuesday, August 10, 2021 12:13 PM
To: info@abtacares@ABTA <info@abta.org>
Subject: Sponsorship / Presentatios
Hello
Noticed one of your sponsors is Northwest Biotherapeutics, are they are doing any presentations at your event?
Thank you
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165381173
American Brain Tumor Association
@theABTA
New Webinar! Learn about post-surgery side effects, the recovery process, and treatments that may be recommended after brain surgery. Register today: http://bit.ly/ABTAAug21 #BTSM #braintumor
@UCLAHealth
New Webinar! Learn about post-surgery side effects, the recovery process, and treatments that may be recommended after brain surgery. Register today: https://t.co/J7acoD4TmC #BTSM #braintumor @UCLAHealth pic.twitter.com/Adf0TPDEKc
— American Brain Tumor Association (@theABTA) August 12, 2021
branster,
I wonder why it took 6 days to get an answer while you got one within hours. Obviously something changed in the past week.
branster,
I asked ABTA for more information about the National Conference.
Sent: Wednesday, August 11, 2021 5:56 PM
To: info@abtacares@ABTA <info@abta.org>
Subject: Question about the ABTA National Conference.
Hey Ambreen,
Noticed one of the main sponsors of the ABTA National Conference is Northwest Biotherapeutics. Is Linda Powers of Northwest Biotherapeutics doing any presentations at the meeting?
And if so, what’s the content of her presentation(s)?
Hello XXXXX,
Thank you for your interest in our upcoming National Conference. Linda Powers will not be presenting during the program.
You can view the program online here. We hope that you are able to attend and find benefit from some of these sessions.
Please let me know if you have any additional questions.
Best,
Ambreen
It has been publicly disclosed that Advent has produced for INMune.
INmune Bio, Inc. (INMB) - FORM 10-Q | Quarterly Report
Nov. 08, 2019 4:05 PM ET
Advent Bioservices
At September 30, 2019 and December 31, 2018, the Company owed Advent Bioservices, Ltd. (“Advent Bioservices”) $0 and $0, respectively, in connection with medical research performed on behalf of the Company. During the nine months ending September 30, 2019 and 2018, the Company paid Advent Bioservices $0 and $298,230, respectively, for medical research performed on behalf of the Company. Advent Bioservices is owned by a significant shareholder of the Company.
Advent Bioservices.
Mike Scott
Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University.
1 day ago
We are recruiting for a Facilities Coordinator to join our expanding Team.
For this and other vacancies, please view our website and feel free to get in touch with us.
https://adventbio.peoplehr.net/Pages/JobBoard/Opening.aspx?v=3b5e25cf-074d-423a-8375-74a4cad28bbf
John Warner
Managing Director Sure-Green Ltd.
23h ago
Looking forward to seeing Advent progress to the next level.
Mike Scott
2h ago
Thanks John, all going in the right direction.
I agree. Great moment. Sending love and healing energy to Jenn.
Bright Boy,
I remember your interesting comment! Thanks!
Bright Boy Tuesday, 04/27/21 05:33:33 PM
Re: None
Post # 372951 of 395779
I am posting this message to help the board begin to realize potentials for Northwest well beyond those that have been posted in the past and to help minimize the very negative posts from JC, LC, Ex and others that certainly have the right to post whatever they like, but definitely do not have the supporting credentials!!!! Hopefully this will help everyone expand their value horizons :):):)
The following comment is the opinion of one of the brightest minds in the world of medicinal chemistry and vaccine creation and happens to be a very close friend of mine. I'm confident that Northwest understands this to the fullest extent!!!
The comment:
A data bank of glioblastoma brain tissue would allow you to identify the antigens in the various cancer samples. If you have enough tissue samples, you could produce a library of antigens that occur in glioblastoma. By using the new RNA vaccine technology, you can produce a vaccine that has the correct antigen mix for a specific person's GBM. This would amount to an "off the shelf" vaccine. It probably wouldn't cover all of the antigens, like DCVax-L, but it would be close.
So there you have it !!!! And Northwest has the greatest library in the history of mankind after 15 years off trials AND will continue to add to that data bank with every treatment/application AND THAT DATA BANK CAN NEVER BE DUPLICATED OR SURPASSED, but can only be improved by the owner!!!! If the future for cancer treatments is vaccine immunotherapy, then Northwest holds the only set of keys!!!!!
Thanks hmuney! It looks like enrollment has been completed.
Here we are in 2021 and I'm preparing for my third craniotomy on June 7th at UCLA Medical Center in Los Angeles, CA. I'm still in shock that this is happening again and so relieved that I was able to be given the LAST SPOT in the clinical trial, which I hope will lead to a cure for Glioblastoma. We need it - too many people are suffering from this horrible disease. I'll be honest - I kinda feel pissed off AF that I'm even climbing this mountain. AGAIN. I dream of the day when I'm not an "inspiring," "brave," and "resilient" "warrior." I'm ready to be "Just Jenn" again!
https://www.gofundme.com/f/jennifershepherd
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
Estimated Enrollment : 40 participants
https://clinicaltrials.gov/ct2/show/NCT04201873
Thanks hmuney! Great find.
Thanks ATLnsider!
American Brain Tumor Association
New Webinar! Learn about post-surgery side effects, the recovery process, and treatments that may be recommended after brain surgery.
EDUCATIONAL WEBINAR
I Had Brain Surgery,
What's Next?
Aug.26 at 1pm CT
Linda M. Liau, MD, PhD, MBA
Chair of Neurosurgery
UCLA Department of Neurosurgery
https://give.abta.org/event/webinar-i-had-brain-surgery-whats-next/e322625
2h.46m.24s
Does anyone have more information about Ratan Dev?
Ratan Dev
Data Integrity/CSV/Labware LIMS/Life Science/Validation Engineer Washington D.C. Metropolitan Area
Beltsville, Maryland, United States
Computer System Validation Engineer
Company Name: Northwest Bio therapeutics
Dates Employed: Feb 2020 – Present (Full-time)
Employment Duration:1 yr 7 mos
Location: MD, United States
Expertise in developing, generating and executing IQ, OQ, PQ protocols. Experience in conducting automated testing, traceability matrix and defect management. Experience in authoring, reviewing and auditing project documentation for validation protocols that includes Validation Master Plan (VMP), test plan and test cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating procedures (SOPs), Process Design Document, Risk Classification Document and Validation Summary Report (VSR)
https://www.linkedin.com/in/ratan-dev-3493419a/
Equity and Justice in Neurosurgery,sponsored by Duke Neurosurgery,
is putting on the first of its kind, Future Leaders in Neurosurgery Symposium for Underrepresented Students tomorrow.
Here is the lineup of speakers!
FUTURE LEADERS IN NEUROSURGERY SYMPOSIUM FOR UNDERREPRESENTED STUDENTS.
Saturday, August 7th, 2021
9 AM EST-4 PM EST
Virtual Conference
FLNSUS SPEAKER LINEUP
Keynote Speaker:
Alfredo Quinones-Hinojosa, MD
Cool Surgery Cases:
Jacquelyn Corley, MD
Tour of the Operating Room:
Nancy Abu-Bonsrah, MD
Career Panel:
Moderator: Rory Goodwin, MD, PhD
Linda M. Liau, MD, PhD, MBA
Edjah Nduom, MD
Analiz Rodriguez, MD, PhD
Research Showcase:
Moderator: Tony Fuller, MD, MSCGH
Allan D Levi MD, PhD
Langston Holly MD
Olabisi Sanusi, MD
https://twitter.com/JacquelynCorley/status/1423643646218362882
Margin Buu,
The Future Leaders in Neurosurgery Symposium for Underrepresented Students (FLNSUS)
August 7, 2021
I got a reply that Dr. Liau is presenting on a career panel.
Registration:
Here is the link: https://duke.qualtrics.com/jfe/form/SV_dgp9qjeLeSM1pL8
futureneurosurgeons
Do you want to become a physician? Are you interested in Neurosurgery? The Future Leaders in Neurosurgery Symposium for Underrepresented Students (FLNSUS) is a unique opportunity for undergraduate students to get exposure to the incredible field of neurosurgery. As a participant, you will have access to extraordinary neurosurgery cases, mentorship from faculty, residents, and medical students, and learn about groundbreaking research from renowned leaders in neurosurgery and the neurosciences. Join us on Saturday, August 7th, from 9 AM EST-4 PM EST.
• futureneurosurgeons
We are super excited to announce that Dr. Linda Liau, the chair of @uclaneurosurgery will be joining FLNSUS as a distinguished guest speaker! Dr. Liau received her B.S. degree in Biochemistry and B.A. degree in Political Science, both with honors, from Brown University in 1987. She received her M.D. degree from Stanford University in 1991 and a Ph.D. degree in Neuroscience from UCLA in 1999. After completing her residency and fellowship training in neurosurgery at UCLA, she joined the faculty at the UCLA School of Medicine. While practicing, she earned an M.B.A. from the UCLA Anderson School of Management. Dr. Liau is a tenured Professor of Neurosurgery and was appointed Chair of the Neurosurgery Department at the David Geffen School of Medicine at UCLA in 2017. She is internationally recognized for her achievements in understanding the immunology of malignant brain tumors and pioneering the use of dendritic cell-based vaccines for glioblastoma. Clinically, she has developed novel ways to map brain function during awake brain tumor surgeries and specializes in surgery for brain tumors in eloquent areas. In 2018, she was elected to the National Academy of Medicine (NAM). She was the first woman President of the Western Neurosurgical Society (WNS) and served as the first woman Chair of the American Board of Neurological Surgeons (2019-2020).
https://www.instagram.com/p/CRza2hMl474/
Antoinette J. Charles@simplyant_
July 26, 2021
We are super excited to announce that Dr. Linda Liau, the Chair of
@UCLANsgy and first woman Chair of the American Board of Neurological surgeons, will be joining FLNSUS as a distinguished guest speaker!
Join me on Aug 7 as I give a tour of the OR at FLNSUS! It’d be a great time! Register here: https://t.co/Cf0Q9eejQk @HopkinsNsurg @tdazad @simplyant_ @LaPetitePedicle pic.twitter.com/U2QCT33Osb
— Nancy Abu-Bonsrah, MD, MPH (@BonsrahNancy) July 20, 2021
LearningEveryTrade,
Yes, lots of exciting career opportunities at Advent Bioservices. They are currently recruiting for a Computer Systems Validation Specialist, GMP Production Scientist, Process Development Scientist, Quality Assurance Officer and…not on their website, a Technician Scientist Apprentice (Level 5) .
The purpose of the Technician Scientist Apprentice is to support the batch manufacturing of the company’s commercial products, to support the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs).
Dr. Bala,
Dr.Jian L.Campian, of Washington University and Siteman Cancer Center:
“The overall patient population in the trial appears to live longer than we would typically see with current standard of care, and 30% of the patients have lived much longer than we would expect, given the typical course of this cancer,” Dr. Campian said.
“In general, patients with this cancer live 15 to 17 months. The surprising part was that the 100 ‘extended survivors’ don’t appear to have the usual characteristics associated with a good prognosis. We are continuing to study these patients to understand why they have done so well.
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14468&pt=msg&mid=22002879
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14470&pt=msg&mid=22003173
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14471&pt=msg&mid=22003244
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14472&pt=msg&mid=22004064
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14473&pt=msg&mid=22007552
https://investorshub.advfn./boardscom/read_msg.aspx?message_id=162372649
LP had indicated publicly (I can't recall where) that they began doing these blinded "Spring Refreshes" starting back in 2015
barcode27 Sunday, 01/21/18 05:00:05 PM
Re: rogers5729 post# 154755 0
Post #
154761
of 392866
Per LP at the meeting in response to a question regarding when they would stop the trial:
I can't spell out a formula for you. We do periodic data collections. When we do a data collection, it's about a 3 month process to collect an update. The independent CRO sends physical staff to all of the sites. We have some 80 sites in this trial. A breathing, human person looks at the files at each hospital and looks at the numbers and compares them to the central database. The central database is kept by an independent data company that's separate from the CRO. And, by the way, the company (NWBO) doesn't do any of this. That process generates what are called queries. Anything where a piece of data is missing or inconsistent, is a query. A data collection process can generate several thousand queries. All of them have to be resolved. Only then do you have a clean data set from the collection. Once you have a clean collection, then it goes to the independent statisticians who then tabulate it. So you have the CRO making the in person visits, you have the queries getting resolved and the independent data company holding the clean data set, and you have the independent statisticians tabulating it. It takes about three months to do that process. We have done it once each for the last three years. We have not made any announcements about the spring of this year, but, it would be a, uh, reasonable thought that there might be a similar cycle in the spring of this year. And it would be the same process, would take three months or so. As we reported in ASCO last year, a huge number of patients, way more than expected, were still alive. We have to weigh that... how much of an additional home run would we get if we continue vs. going with what we have now.
Dr Bala,
I think the quote, posted by sentiment, is not so clear for most ihub members without corresponding (confidential?)information.
I do not believe pseudoprogression would be the cause for 1) a partial halt, not a full halt, never announced by the FDA (I believe), and if they were hiding something you can bet the FDA would unhide it
In addition to the planned interim analyses for the primary outcome, a sample size re-estimation will be performed after 80% of the 348 patients have been randomized. An independent statistician (IS) will be provided a dataset with all available primary outcomes (i.e., times to progression, death, or censoring) forthe randomized cohort, without treatment group assignments. The IS will calculate the Kaplan-Meier curve for the combined randomized cohort (DCVax-L-treated and placebo treated patients). The median time to PFS (M) will be-estimated from this curve. The IS will use M as the assumed median for the placebo group. The IS will then calculate a sample size assuming a median PFS of M for the placebo group, and the same hazard ratio, Type I error rate and power used in the original sample size calculation.
branster,
On the 5th of May Joel had his fourth and final dose of Dendritic Cell Vaccine, (DCVax-L), at Kings College Hospital in London, with Professor Keyoumars Ashkan.
Yesterday update:
Dear friends, family and generous supporters. We are aware that we haven’t updated you for a while. We have been waiting for Joel’s latest scan results, which we’ve just had and are stable, thank goodness.
Thanks ATLnsider!
November 10, 2020
Richard Pazdur, MD, Awarded the Simon M. Shubitz Cancer Prize and Lectureship
Looking to the Future
What might the next 4 decades bring in advances in oncology care?
“Progress in cancer will come from our ability to rely on biomarkers to find cancer before the tumor becomes radiographically detectable. And treatment will center on immunotherapies that activate the immune system to fight this early disease,” said Dr. Pazdur. “I imagine a time when cancer will be detected from a blood test given during patients’ annual physicals, and we will have immunologic drugs that will activate the body’s immunologic defense to eradicate those very early malignant cells. This is my aspirational hope for the future.”
But there would be nothing to sue on as NWBO never denied a 2014 IA happened.
We anticipate that the Phase III trial will reach its first interim analysis for efficacy during 2015. Various factors may affect the timing of completion of the trial, including the pace of adding more sites in Europe during 2015, and the pace of enrollment in Europe. We anticipate that the Phase III trial will reach its primary endpoint next year, potentially in the spring or summer.