flipper44
2 hours ago
Excellent Observation by XMaster!!! Many Thanks🙏
It confirms my thoughts that our patent application on Hyperactive Dendritic Cells directly/cooperatively draws from these studies.
By the way, as you know, “J.C.K” and “D.Z.” are lead authors
Jonathan C Kagan and Dania Zhivaki
Interesting acknowledgment in the 2nd article
“Acknowledgments
We thank the NIH Tetramer Core Facility for providing the OVA tetramers. This study was supported by NIH grants AI167993, AI116550, and DK34854 to J.C.K.; AI007245-34 and AI007245-35 to D.Z.,; AI170632 to I.Z.; and DK043351, Klarman cell observatory and Broad Immunology program funds to R.J.X. This work was partly funded by Northwest Bio to J.C.K. D.Z. was also supported by the Charles A. King Trust Postdoctoral Research Fellowship Program. “.
And the 3rd article
“ACKNOWLEDGMENTS
We thank D. Mathis (Harvard), J. Lieberman (Harvard), and N. Joshi (Yale) for advice on this work and the NIH Tetramer Core Facility for providing the OVA peptide tetramers. This work was supported by NIH grants AI133524, AI093589, AI116550, and P30DK34854 and Northwest Bio to J.C.K. D.Z. was supported by the NIH T32 appointments AI007245-34 and AI007245-35. A.K.S. was supported by the Pew-Stewart Scholars Program for Cancer Research, a Sloan Fellowship in Chemistry, and the NIH (1DP2GM119419, 1U54CA21”
XMaster2023
4 hours ago
Interesting acknowledgment in the 2nd article
“Acknowledgments
We thank the NIH Tetramer Core Facility for providing the OVA tetramers. This study was supported by NIH grants AI167993, AI116550, and DK34854 to J.C.K.; AI007245-34 and AI007245-35 to D.Z.,; AI170632 to I.Z.; and DK043351, Klarman cell observatory and Broad Immunology program funds to R.J.X. This work was partly funded by Northwest Bio to J.C.K. D.Z. was also supported by the Charles A. King Trust Postdoctoral Research Fellowship Program. “.
And the 3rd article
ACKNOWLEDGMENTS
We thank D. Mathis (Harvard), J. Lieberman (Harvard), and N. Joshi (Yale) for advice on this work and the NIH Tetramer Core Facility for providing the OVA peptide tetramers. This work was supported by NIH grants AI133524, AI093589, AI116550, and P30DK34854 and Northwest Bio to J.C.K. D.Z. was supported by the NIH T32 appointments AI007245-34 and AI007245-35. A.K.S. was supported by the Pew-Stewart Scholars Program for Cancer Research, a Sloan Fellowship in Chemistry, and the NIH (1DP2GM119419, 1U54CA21
theorysuit
4 hours ago
from 2022 ASM
More of the same externalizing BS that the pump crew have been trained on by NWBO. Of course LP says the same BS externalizing blame game......SMFH when your CEO keeps crying instead of executing. Come on Pump crew let's keep blaming everyone but NWBO for their failures. Pathetic failure on LP to shareholders. She hasn't failed herself as she returned multiple fold already on her investment (AKA Cognate/Advent). Keep playing this on repeat while you get diluted to the outrageous shares authorized balloons to over 2 Billion shares.....
So again, it's a question of the expenditure and the time lines. Last question. Since manuscript publication, attacks on the company have increased several fold. Are there any plans to at least refute some of these and et cetera? Let me tell you, we are acutely aware of all of the attacks. The attacks are just incessant, they're relentless. But we'll say that we find it quite shocking that even doctors associated with companies and that have competing technologies have indulged in attacks that have used fault information, false claims about our trial, how it was conducted, et cetera.
It's pretty shocking that -- I mean, the other companies in this space of each attacked us -- I mean, -- we kind of view the attacks as an indicator that people think we've got something important. If we don't have anything important, why bother, why bother, why try to attack us. But we do find it quite shocking that these parties just want to stop another treatment from getting to patients. These brain cancer patients need another treatment option. They need a lot of more treatment options, the more the better.
And anyway, yes, we're acutely aware of the attacks. We've already taken the first step on dealing with the attacks that we think have come from financial parties with the lawsuit that we filed and the attacks in what we believe to be manipulation there. We are, I would just say, exploring other steps to take to fight back against some of these attacks.
The one thing I would say is, and I know you guys want to see us standing up for ourselves and fighting back, the challenge is every hour that we spend doing that is an hour, we don't spend on all those other works that I just spent a long time describing to you. And it's a real balancing act because the attacks come in from all sides, you guys -- a lot of you guys have done wonderful jobs of outing some of these folks outing attacks by -- even by doctors who have undisclosed connections with competing technologies.
You guys as shareholders have done a wonderful job. It's amazing what you guys find and how fast you [indiscernible]. I have said that I think the [indiscernible] should lay off all their employees and just contact with you guys because you find everything faster than anybody. But in all seriousness, is serious. We try to strike a balance between taking action, but not diverting too many of those precious hours from working on the applications for approval because that's what the attackers want. They want our time, attention and resources to be diverted and taken away from making progress.
dstock07734
9 hours ago
Sounds like you are ready for UK approval.
No one is giving upfront non dilutive cash to NWBO
What a ludicrous prediction! You and your buddy really need to do homework on the company before betting against it.
Now read the following article to prime yourself first.
https://www.takedaoncology.com/news/our-viewpoints/better-together-our-aspiration-to-cure-cancer/
Better Together: Our Aspiration to Cure Cancer
Author: Teresa Bitetti, President, Global Oncology Business Unit
Curing cancer is an enormous task. And, like any difficult task, it will take the involvement of many individuals to accomplish. At Takeda Oncology, we’ve uniquely designed our team to remain agile and move with an ever-changing, dynamic industry. And I’ve found three key components to be integral to our progress and critical to our success — ones that I believe can apply to many organizations:
1. Structure a team unique to your goals
The Oncology Business Unit (OBU) at Takeda functions as a separate group within our company. This gives us the resources and dependability of a large pharma company and a structure that allows us to move with the speed and agility of a biotech—allowing us to blend the best of biotech and large pharma experiences. We seek to advance cancer care for underserved populations, and this has yielded a pipeline that is sharply focused on introducing new treatments that bring needed value to patients.
The strength of our portfolio would also not be possible without the diversity of our team. We value different cultures, backgrounds, interests and experiences because varying perspectives have proven vital in developing and launching new therapies. While a diverse team and unique internal structure is critical, it’s important that our external partners align with our organizational goals as well.
2. Establish the right partnerships
Our unique structure within a large global organization gives us flexibility in how we develop meaningful partnerships with other companies and organizations. For Takeda Oncology, we are always looking for partners who we can help, and who can help us, as we go forward together with a shared aspiration to cure cancer. Our partners represent the best in cutting-edge science and innovative advancements, and through our collaboration on promising platforms and investigational therapies, we’re working to optimize and expand our oncology pipeline. Our progress to date would not be possible without a broad range of partners such Ascentage Pharma, HUTCHMED and GammaDelta Therapeutics.
Nonetheless, it takes more than scientific discovery to cure cancer. We need to learn more about the patient experience from the patients themselves, and we need to do all we can to ensure that patients around the globe have access to our innovative treatments. This is why we partner with many patient organizations. For example, after licensing our treatment for metastatic colorectal cancer (CRC) from HUTCHMED, we joined forces with leading advocacy organizations worldwide to create a unique patient survey to help us determine how we can best address their needs. You can learn more about our patient partnerships here.
3. Be willing to reinvent yourself and grow
Some of the biggest brands in the world—Apple, Netflix, National Geographic—have leveraged emerging technology to revolutionize the way they operate and advance as businesses. The healthcare industry should be approached with the same frame of mind; we must be willing to change and evolve as technology advances and patient needs change.
Such evolution is core to who we are at Takeda Oncology. Our oncology business used to be significantly smaller than today, with a portfolio primarily focused on hematologic malignancies, or blood cancers. Now, we also have solid tumor therapies and have established a pipeline of investigational therapies with the potential to attack cancer from multiple angles. This progress has positioned us to develop more treatment options for patients who have difficult-to-treat cancers. We’re proud to have grown through thoughtful, strategic partnerships and a deep understanding of the ever-evolving oncology landscape.
Cancer is a clever and difficult opponent. At Takeda, we know we cannot defeat it on our own and must continue to work in agile and innovative ways, seek partners who share our goals and evolve as needed to meet patient needs and thrive in a dynamic landscape. It is this unique village, comprised of internal and external partners, all working toward the same goals, that will equip us to achieve our aspiration to cure cancer.
skitahoe
11 hours ago
WideEyed, the only way they get it is if they're ready to accept the EDEN unit for commercial production. Without that NWBO lacks the production capability needed to support approval.
I think it's possible that Canada, or even Europe would piggyback off the UK approval, but they'd be hard pressed to live on just manual production at Sawston. I believe the demand will greatly exceed the supply, how do you decide who gets this life saving technology.
Certainly the pressure should be on the regulators to find a way to approve the EDEN, but until that occurs a few hundred batches can be made in a month, and tens to hundreds of thousands of batches of the vaccine will be needed worldwide. Of course this is for GBM, add some other solid cancers and you can just move the decimal point a couple places to the right.
Gary
skitahoe
12 hours ago
I've learned through the years to never call anything 100%. I've seen the FDA accept everything that was submitted and met all the criteria they established for approval, but they still asked a question which took another small trial to answer. It was a stupid delay, no telling how many lives were lost, but that's how the FDA operated. If they wanted to know something, even though they never asked about it during trial development, they delayed approval till the question could be answered.
Worst case I can think of, a drug which saved newborn babies with a certain problem was delayed for years because the shelf life was found to be under 3 years. It took years before the problem was fixed, and the babies died until that happened. Why couldn't they grant an approval with restricted shelf life?
I'll never understand how when your eyes and other senses tell you a drug is performing miracles you must wait for a BLA or NDA to be prepared, something which might take a year or more, than at least 6 months more to evaluate the filing. All your senses say something should be available, but their rules say everyone must go through the hoops, so ignore your senses and wait years. Why can't they just use a EUA until full approval can be granted. I'll bet if it were an FDA staff member that had the disease a way would be found to get it, why not the rest of us.
Gary
skitahoe
13 hours ago
Never is a very long time. I've believed many products were certain of approval in my lifetime. In a couple cases the regulator did delay them, but all that I felt certain of were eventually approved. I've felt certain that DCVax-L would eventually be approved, I still believe the chance is greater than 90% it happens with the UK on the current submission. Time will tell.
As for prices, I've been wrong about the timing, but I still believe all the dollar figures I've mentioned will be achieved in time. I felt much the same about IMGN, it took decades longer than I thought, but it did happen and I still believe they sold way too soon.
Gary
Horseb4CarT
14 hours ago
Amen!
Adding to Gary's always cogent and even keeled comments about the market system, it's reminiscent of the old line, paraphrasing, "they rob banks because that's where the money is."
The markets are where a whole lot of money is, and as the Mathew McKonahey (sp?) character in Wolf of Wall Street says, "you have to get the money from their pocket to your pocket!"
Unfortunately, it's our pockets that they're taking our money out of with impunity and I'd say disdain but I doubt they give us any thought whatsoever.
To be clear I don't think everyone working in the markets is a bad actor, however imo those who call the shots, like our familiar MMs and hedgies and many more who lurk in anominity by choice are suspect, and a whole lot of palms get greased in and out of government.
I guess it's been this way for the ages.
Power corrupts and absolute power corrupts absolutely!
Oh, I almost forgot, Merry Christmas and a Happy New Year!
Chiugray
15 hours ago
Skitahoe, Point taken, there will always be a base level of manipulation in the markets. Wrt the portion that I consider extreme manipulation, I see NWBO has been in a multi-year bear raid by manipulators, and that is about to end. And there will be a massive price recovery to offset. Who and how that all plays out is tbd, but it will be a natural first step.
For example: Post-approval Shorts will incur major and cascading losses unless they cover. Short positions are mark-to-market liabilities (unlimited loss potential), not investments. DCVax is an emerging unicorn company and has a broad and long term growth potential. Because of all that, Shorts will face continued exponential risks of majors losses if they don't cover. At each step-up in NWBO's price, lenders will issue Short's margin calls. Their shareholders will start criticizing them, asking them uncomfortable questions like "why in the f did you short a unicorn company" and "why did you not cover already". Then the pressure of auditors and financial reporting matters will compound.
Regardless, we Longs trust that the science, due diligence, and free-market investing money flows will move the stock price in a trajectory towards intrinsic value. And with approval, validation, that continually growing intrinsic value will begin to accumulate a large premium.
skitahoe
15 hours ago
My first investment experience, which I mentioned, was a lesson I hope people here will recognize. As I mentioned, my father put me in a stock, back then they were listed daily in the newspaper, and I routinely watched it. I saw if fall to a small fraction of what it was when he bought it, then rise.
When it was up substantially, at least a double of what it was purchased for I asked my father about it, he told me he sold it when we broke even and put it into a hot new mutual fund with a brilliant fund manager. That fund went nowhere.
The lesson clearly is when a stock's down, then it comes back, don't get out just to break even. Look at the reasons that brought it back up, ask yourself if it has the potential you saw when you originally invested, if so, why sell.
My belief is that NWBO's potential has grown in all the time I've been invested, whether the price was up, or down, the potential keeps increasing as we learn more about what the vaccine can do for a variety of cancers.
To me, this makes NWBO a good stock. I like Will Rodgers stock advice, it doesn't get simpler, buy good stock.
Will Rodgers dies well before I was born, but his cowboy philosophy makes a great deal of sense, even today. Most today may not have heard of him at all, but when I was a kid he was still admired in spite of being gone for many years.
Gary
skitahoe
15 hours ago
Chiugray, that's the way I like to feel about nearly all my investments, if successful they should be of benefit to mankind.
My first investment in stocks occurred about 70 years ago when my father bought me some shares in a company. I don't believe back then that shorting, hedge funds, etc. even existed and frankly I believe the investment world was a much better place back then.
I can remember when I was young looking through Annual Reports that were largely like a magazine ad for all the good things the company was doing. Certainly they had financial data, but they weren't loaded with all the warnings on how you could lose your money by investing.
Sadly I think the regulators have caused all this to change, as well as all the financial vehicles that have been put in place that allow people to make more money in bringing companies down than by investing in corporate growth.
2008 was certainly an example of where the greatest money was made by hedge funds, many of the biggest managers made over a billion in their bonuses, and they were largely for bringing down some of the worlds biggest companies, including many financial institutions. Nothing they did may have been illegal, but an industry built to bring others down just doesn't hack it in my book.
I once discussed why such investment was even legal with my broker. His answer was simple, if they made it illegal here, it would be made legal somewhere, and that's where the business, and the money, would move to.
Ultimately I believe that most stocks are being manipulated by Institutions, MM's, and large investors and we can only hope that in time they plan to make a huge success out of our investments. Certainly things like drug approvals will move them up, but how far is largely in the control of others who decide whether to hold it down, or let it run.
Certainly, moving to a few dollars on approval should be the least we see, but could we run to $10, $20 or more, that's a decision that goes to the manipulators to decide, if they decide in our favor, we'll all be celebrating sooner, rather than later. Don't get me wrong, if we're not bought out we'll eventually achieve these numbers, and more, the only question is how soon, and the answer's in the hands of others way above us.
Gary
Chiugray
16 hours ago
Horseb4CarT, Well said. Bashers and paid mercenaries travel a steep slippery slope of degenerating moral and ethics. Much healthier to support good causes. And in the world of probabilities and statistics, we should all support DCVax's success for the sake of friends, parents, siblings, children, self, and society overall.
dstock07734
17 hours ago
You still think it is an easy target? Have you and your buddies trapped deep enough? Great. Keep digging.
In the meantime, put the following in your mind.
From ASM
But we have said in every presentation, we are eager to combine DCVax-L with these other combinations. And so one of our many priorities, for the going forward period, is to do one or more of those combinations. And we've received considerable interest from various parties for that. So, we are looking forward to that.
From 10Q
Collaborations: Complementary or Synergistic Technologies. The Company has also been pursuing ongoing efforts to identify and develop collaborations with other companies who have technologies that the Company believes may be complementary to the Company’s DCVax technologies (for example for combination treatment regimens) or may be synergistic with the Company’s technologies (for example, to enhance DCVax products). The Company completed negotiations and entered into a contract with a company that has a complementary immunotherapy agent, and the two companies have been engaged for a number of months in joint development of trial designs and selection of candidate cancers for a combination treatment clinical trial. The companies are particularly focusing on trial designs in which the primary endpoint will be tumor response (shrinkage), with potential timeframes in months, rather than time-to-event survival outcomes, with timeframes in years. The Company anticipates potentially being ready to submit an IND for such a combination trial to regulators during Q1 of next year.
Merck is requesting permission to work extended hours beginning Sunday, December 27, 2021 through Sunday, May 31, 2021 to perform after hours work from 6AM to 10PM as well as selected Sundays during
this time period.
Merck is requesting permission to work extended hours beginning Monday November 22 through Friday December 31, 2021. Work hours are requested to revise the fenced perimeter of the upcoming project site.
Work hours are requested to be Monday through Saturday 6AM to 10PM and Sundays from 8AM to 5PM.
Merck is requesting permission to work extended hours beginning Monday April 25 through Sunday December 18, 2022. Work hours are requested to be Monday through Saturday 6AM to 11PM and Sundays from 8AM to 5 PM.
Merck is requesting permission to work extended hours beginning Monday December 5, 2022 through Monday July 31, 2023. Work hours are requested to be Monday through Saturday 6AM to 11PM and Sundays from 8AM to 5 PM.
https://joblink.maine.gov/jobs/655412
The Building 63A Syringe Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up of a new vaccine formulation & filling facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility license.
The Senior Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others.
Additional responsibilities include:
+ Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility
+ Partner with cross functional team to develop process/procedures and complete successful qualification of equipment/process.
+ Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification
+ Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
+ Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings
+ Support process improvement projects and complex manufacturing investigations
+ Support digital and data integrity initiatives for the project
+ Provide technical support to manufacturing for complex problems and issues
+ Develop and assure consistent application of standardized work, engineering, and process tools
+ Examine issuesfrom diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause
+ Support regulatory submission preparation and inspections for the facility
skitahoe
18 hours ago
NWBO will never successfully complete the Phase 3 trial, they'll never get the Journal, they'll never submit to a regulator, they'll never get approval in the UK, they'll get approval, but NICE won't agree to fund the purchase of the vaccine. All the above are some of the things bashers have been saying in the roughly half dozen years I've owned the stock. Of course the biggest claim is, NWBO will never get approval, I can't say how many people I've heard that from.
Today, most of these people are quiet about saying it won't happen, many have even conceded that it could, so they're turning their guns on NICE because without NICE people will have to pay even with a UK approval. I'm sure that much else was being said that was equally wrong before I ever invested, but I feel confident they're wrong about everything they've said.
Predicting the future, they'll be saying none of the other regulators will approve after the UK approval and NICE concurrence to pay for the vaccine. They'll say that the EDEN Unit will never be approved for commercial production. And when all the regulators have approved, they'll be saying no big thing, they'll be lucky to do a couple billion a year in sales.
The bashers just keep backing up, with each success they establish a new position where they say we'll fail. I don't know that we'll ever be done with the bashers, but I'm looking forward to the day that they're saying we'll never reach a triple digit billion dollar market cap. Even then we'll prove them wrong.
Happy Holiday's all,
Gary
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