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DOES BROOKLYN GROW THE SMARTEST GUYS ?@alphavestcap $nwbo
— alphavestcapital.com (@alphavestcap) March 7, 2024
Nemesis18 Re: exwannabe post# 676758 Wednesday, March 06, 2024 3:32:29 PM Post# 676783 Correct. I stopped all cancer related treatment & oral medication after just 6 weeks of chemo radio. There was to be a follow on… pic.twitter.com/4MQx7s2rzi
Nemesis18
Re: exwannabe post# 676758
Wednesday, March 06, 2024 3:32:29 PM
Post#
676783
of 676884
Correct. 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.
I received a phone call on my way home from the clinical trial patient procurement Nurse Specialist to say that on pathological review of the tiny calcified fragments of the removed brain abscess, it was determined that I had just two weeks to live with GBM4.
I was referred to an oncologist, who stated that I was fortunate that he had just one place left on this very latest NICE gold standard treatment.
And I had to agree to it right away,? as it was the final day of this treatment offer.
So as you all make disparaging assumptions about me, that is the reality.
Incidentally, You’ll note from Kings PR blurb that a Guy called Nigel French was diagnosed with GBM 4, just two months after me. He was the final trial patient directly recruited by Kings.
He lives to this day also
iwasadiver
Member Level
Re: Nemesis18 post# 676783
Wednesday, March 06, 2024 6:01:35 PM
Post#
676858
of 676885
I’m a bit late to this game but I’m quite confused as to how a person with a brain abscess that was found to contain a tiny bit of calcified GBM (now re-classified as an Astrocytoma wild type) who started on this forum only a few days ago, and who’s first postings suggested he had no postulations as to the outcome of a filed MAA has worked his way into a position that he actually now IS making a claim that said MAA will be rejected at the coming CHM meeting based upon testimony he gave to the MHRA and NHS. How am I doing so far?
First, am I correct in asserting you’re upset that you’re still alive 9 years after a diagnosis of GBM because you feel you were misdiagnosed? Is it your contention that if you really had a non methylated GBM by today’s WHO classification you’d never have made it this far without any treatments beyond the surgery and some chemo?
Second, just so we’re clear; while rare, brain abscesses are indeed found in GBM and Astrocytoma, among other types such as Meningiomas (Meningiomas are outside the blood/brain barrier so not so unusual). And when found they’re usually extensions from sinus infections, which can be extensions of erosion of a deep tooth abscess into the maxillary sinus, then further extension from there. So I’m not sure if you’re claiming that you never had cancer in the first place because you had a simple abscess or if you’re claiming you’ve had a fantastic recovery from an Astrocytoma without ever having much treatment beyond the original surgery and chemo/rad?
Third; I’m confused as to what damage you’re claiming that would have sent you to do a series of interviews with regulators regarding the DCVax clinical trial? What part, if any, played a role in your current perspective? Are you claiming the Nurse administrator of the trial coerced you to join the trial that you claim you didn’t join? Or is it that you claim that King’s College was so eager to get you into the trial because of what you call a “favorable presentations and overall genomic profile”? What I see from 2015 you didn’t have a favorable genomic profile in the non methylated status of your tumor at least. Are you claiming you were part of a “cherry picking” of trial participants? Further, I’m a little confused that you were diagnosed in 2015 (must have been before May because the partial hold would prevent any screening of new patients after that) with a GBM4 and were the “first person in the world” be be reclassified under the new WHO classification in 2021, but it was 9 years later; which would be now, correct? It took 3 more years to be the first in the world to have a reclassification from the original pathology? Interesting for sure
Fourth; You were on Lamotrigine for seizures. Were you on a steroid regimen at that time? There’s some developing evidence some anti seizure medications, especially with steroids (but also without) may inhibit brain tumor growth
What I’m seeing makes no sense; you’ve got some axe to grind but it’s not clear what precisely it is. Any clarification on the above points would be appreciated
brooktrail1933
Re: iwasadiver post# 676858
Wednesday, March 06, 2024 6:42:56 PM
Post#
676870
of 676885
He said his tumor was in the temporal lobe. And that when they removed the "abscess" they found GBM. I've never heard of a brain abscess related to an infected upper tooth somehow finding its way to the temporal lobe. The ones I've seen related to sinus disease were all arising from a frontal sinusitis. Not aware of a neurovascular pathway from the maxillary sinus to the temporal lobe.
Bottom line - this guy is a fraud, reading off a card in a boiler room somewhere. Hired by a hedge fund or helmet company, or maybe related to the rad-oncs in the UK who were unhappy with the trial results and complained to the journals. IMO.
iwasadiver
Member Level
Re: brooktrail1933 post# 676870
Wednesday, March 06, 2024 9:14:54 PM
Post#
676877
of 676885
Well, I’m not saying it’s rational. But if someone’s immune compromised and it’s a smoldering infection it can keep moving throughout the sinuses in theory or become bacteremic. Plus GBM/Astrocytoma have a nutrient rich hematoma that can become infected via that bacteremia but that’s all just speculation. My only point is it can occur outside of the area of the sella even though that’s the most likely spot from the sinuses.
I was simply trying to point out to more seasoned investors and others in the field (I’m an Emergency Physician) that this guy’s stuff doesn’t add up well and just trying to avoid the hyperbole that’s rampant here at times.
https://t.co/iTwkMzF1Gf…Is this like Michael Corleone paying the funeral expenses for the heads of the NYC five families after he has had them murdered ? https://t.co/fxJdyN8WwL…@alphavestcaphttps://t.co/M3HQTfyAMP https://t.co/vUSA0QP2Mp… https://t.co/nqJTXxH4Cg…doc,…
— alphavestcapital.com (@alphavestcap) March 7, 2024
@alphavestcap $nwbo https://twitter.com/TonyTassell/status/1763947304048844920…Landmark $50M naming gift to Sylvester at the @univmiami represents a commitment to continue world-class breakthrough #CancerResearch at the new Kenneth C. Griffin Cancer Research Building. Read more about the gift’s impact on the #SouthFlorida community: https://t.co/lrnPbNmHwN.… pic.twitter.com/NOYHXp0PsU
— Sylvester Comprehensive Cancer Center (@SylvesterCancer) March 5, 2024
Every day , Ken Griffin-Citadel , accompanied by a complicit U.S. government, "sets" the price of $nwbo( see Ken explain in a video below) (and maybe 50% of all U.S. stocks) , intending to bankrupt a breakthrough dendritic cell cancer vaccine (DC VAX L) ; a vaccine which has proven in clinical trials since 2010 that 50 % of GBM patients live 10 years, versus life expectancy of 16.5 months dosed with standard of care .
https://twitter.com/AllenTurner206/status/1625866069780070401
P.S. be sure to read the MD and A section of $nwbo's '23 10-K, filed 3/5/24 at http://sec.gov.
alphavestcapital.com
@alphavestcap $nwbo
https://twitter.com/BillyM2k/status/1734212639306514825…
https://twitter.com/alphavestcap/status/1765387684900479400
https://sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001072379/000141057824000133/nwbo-20231231x10k.htm……
"Bright Boy Tuesday, March 05, 2024 6:28:26 PM I will start by saying that in my career I have managed two public companies, one the New York Stock Exchange, the other on the ASE, over a 15 year period and pride myself in having written some of the better MD&A sections of our annual 10K filings. I just had the great pleasure of reading Northwest Bios 10k, with special attention to the MD&A section, and I can honestly tell you that I have never read an MD&A section as expertly written and that articulately described the process. I am most impressed with the discussion regarding the intellectual property of the company stating that the years of data on Dendritic cell based technology create a terrific franchise for the company to be used and shared by the entire healthcare industry. This of course includes individual DCVax-L Applications as well as the mini combinations with other existing excellent cancer treatments that only become better with the addition of DCVax-L process Technology. Additionally, the discussion of the Flaskworks manufacturing facility enables the company to monetize and commercialize all of that franchise in a way that they're able to meet and scale to demand for all cancer patients with large tumor cancers or other cancers that are in desperate need of our technology. I should go on forever but the important thing is to keep it short and ask everybody to pay special attention to the MD&A section which is brilliantly written. Cheers, BB
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read this discussion together with the Financial Statements, related Notes and other financial information included elsewhere in this Form 10-K. The following discussion contains assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors,” and elsewhere in this Form 10-K. These risks could cause our actual results to differ materially from those anticipated in these forward-looking statements.
The following Management’s Discussion and Analysis provides a historical and prospective narrative on the Company’s financial condition, and results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022. The discussion of the Company’s financial condition and results of operations for the year ended December 31, 2022 compared to the same period in 2021 is included in Part II, Item 7. Below includes Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report on Form 10–K for the year ended December 31, 2023.
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. Our additional product, DCVax®-Direct, is designed to treat inoperable solid tumors.
During 2023, we completed or made substantial progress on all of the key areas that we outlined at the Annual Meeting in December 2022 as priorities for the following 12-18 months, as well as some additional areas not outlined at the Annual Meeting.
Sawston Facility Development. We continued the development of our GMP facility in Sawston UK. We believe that the facility is a major asset and that the ongoing development is materially further enhancing its value.
?The MIA license was approved by the Medicines and Healthcare Products Agency (MHRA), authorizing commercial manufacturing in the facility as well as global imports and exports - the culmination of several years of work.?The buildout of Phase 1B of the facility, which had begun in 2022, was completed. This included a large new Process Development (PD) lab that helped substantially with the Flaskworks development activities during the remainder of the year. The new PD lab will also be useful for future work on next-generation technologies, including as part of collaborations that are under development.?Controlled GMP cryostorage: existing capacity for 3 million vials.?Engineering and technical analyses were carried out for development of new Grade C labs in which the Flaskworks system may be deployed at lower cost and greater quantities of production than the existing manufacturing processes in Grade B labs.
Product Release Improvements. We continued to streamline processes related to product release. After manufacturing, medical products must go through a range of “release tests” - i.e., quality control and other tests (composition, purity, potency, sterility, etc.) to be approved for release for use in patients. In order for scale-up of manufacturing to be effective, the product release process must also be streamlined and scaled up so that it is not a bottleneck. This is an important part of overall preparations for commercialization and is particularly critical for autologous (personalized) products, for which each “batch” of product that is released is only for one patient. We have been
23
Table of Contents
working on this for years and made substantial progress in 2023. Activities have included partial automation and acquiring specialized equipment and bringing in-house some key tests previously conducted by outside specialized vendors.
Flaskworks. Major progress was made in 2023 in the development of the Flaskworks system for a “closed” manufacturing process for DCVax-L. We completed the evaluation of three fundamentally different process approaches that the Flaskworks system could take, and chose the one that we believe will be optimal both operationally and to facilitate regulatory approval. We also completed most of the functional optimization of the Flaskworks system itself. A specialized contractor was engaged to produce GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients. As previously reported, the Company views the Flaskworks program and system as a centerpiece of efforts toward scale-up for potential commercial operations.
Supply chain issues and equipment backlogs continue to be factors affecting operations both for Advent and for Flaskworks. However, the work of both Advent and Flaskworks is progressing in spite of these issues.
Intellectual Property. We further strengthened our intellectual property portfolio in three ways during 2023: we achieved issuance of certain patents previously filed, we filed new patent applications based on our own work, and we in-licensed patents and patent applications from other parties. We are continuing to build an IP portfolio that we believe will provide a strong foundation to help us build a leading franchise in dendritic cells and active immunotherapies. This includes enhanced versions of dendritic cells, combinations of other agents with dendritic cells, manufacturing methods and processes, and related IP.
Collaborations. The Company continued active discussions on certain combination treatment regimens and is planning for certain strategic trials with such combination treatments. Some of these would be in connection with the Company’s in-licensing of intellectual property and others would be separate collaborations. The Company anticipates proceeding with such an initial combination during 2024 when it is able to free up sufficiently from the MAA review process and the inspections processes.
Expansion of the SAB: addition of Dr. Linda Liau. We were pleased to expand our Scientific Advisory Board during 2023 with the addition of Dr. Linda Liau, Chairman of the Neurosurgery Department at UCLA and the Principal Investigator in the Phase 3 trial of DCVax-L for GBM.
Mechanism of Action data and analyses. During 2023, we completed and publicly presented key information about the mechanism of action (MoA) of DCVax-L. We have undertaken such analyses over time, as technology tools have advanced - including recent advances in proteomics. The analyses completed and presented in 2023 provided strong support for what we believe are the keys to the treatment effects observed with DCVax-L and are the key differentiators of DCVax-L vs. other cancer treatments for glioblastoma (GBM) and other solid tumors: namely, that DCVax-L is a broad-spectrum treatment and it is aiming at personalized tumor targets that are actually present on the patient’s version of the tumor. The MoA studies showed that the dendritic cells in DCVax-L processed and presented well over 600 peptide antigens (all drawn from a sample of the patient’s own tumor) to the T cells. The antigens presented by the DCs become targets for T cells to attack. The MoA studies also showed that a very large number and diversity of T cells responded, and that the depth and breadth of the T cell response increased over time following DCVax-L treatments, ranging ranged from several hundred to as many as 1200 different T cell clones. Each T cell clone addresses a distinct tumor target. We believe that the data from these MoA studies provide important support for the extended survival seen in our Phase 3 clinical trial of DCVax-L for GBM and will be helpful in the regulatory review of our MAA application for commercial approval.
Continued compassionate use (Specials) patients. We continued treating compassionate use cases of GBM patients. We believe these treatments are helpful for the patients, and these cases are also helping us prepare for real world circumstances that we are likely to encounter in potential commercialization and that are much more diverse than in clinical trials. For example, the compassionate use cases include patients who have continued to receive DCVax-L treatments over many years (including having a second batch of DCVax-L doses made after the first batch of doses was exhausted), patients who are older than the age range in the clinical trials, and a patient with an enormous (14 cm.) GBM tumor of which only half could be removed by surgery and the remaining half regressed with treatment by DCVax-L and nutritional support for the immune system (case study accepted for peer reviewed publication).
Continued survival follow-up on patients in the Phase 3 trial. The contract research organization (CRO) managing the Phase 3 trial continued to conduct long-term follow-up on patients from the Phase 3 trial as there are still patients alive.
24
Table of Contents
Drafting and submission of the MAA. We worked with consultants throughout the year to draft the MAA application package and supporting documents and exhibits. Advent BioServices undertook much of the work with specialized consultants to prepare the CMC (product related) sections of the MAA and those supporting documents and exhibits. The MAA was completed and filed with the UK MHRA on December 20, 2023.
Activities associated with the MAA. In parallel with the drafting of the MAA itself, in 2023 we undertook a large-scale program of preparations for inspections. The regulatory authorities will conduct comprehensive inspections of the CRO, the TMF, the database provider, the sponsor, key trial site hospitals, the contract manufacturer and others. The Company worked throughout most of 2023 with large teams of consultants on preparations for inspection readiness of all parties and the TMF. Multiple mock inspections were arranged and were conducted by former regulatory agency inspectors in Q4. Further inspection readiness preparations are expected to continue to be a major focus of the Company and the large teams of consultants in the first half of 2024. During 2023 the Company also devoted substantial efforts to preparations for launching the two required pediatric clinical trials.
Lawsuit against market makers. The Company continued vigorously pursuing its lawsuit against certain market makers whom the Company believes have engaged in manipulation of its stock. Following the Company’s filing of its Complaint in December 2022, during 2023 the case proceeded through multiple rounds of court filings as described in Item 3 Legal Proceedings above. The Company plans to continue the vigorous pursuit of the case.
Future directions. In the future, we also plan to restart our DCVax®-Direct clinical development program as soon as resources permit.
https://twitter.com/alphavestcap/status/1765387684900479400…
AVC's BIG PICTURE:"
…"24's biggest Wall Street story could be what Posner discovers when her team pours over the books at Citadel. Everybody knows their profit is $15 billion annually . They are in the business of touching 50% of all U.S. equity trades .Citadel was founded in 2002. With high speed chips and algorithmic software, their trading techniques got out ahead of the I.Q. of regulators and politicians who were blind to Citadel's profit extraction from the trading in securities markets. In effect, Citadel figured out how to tax(like $15 billion) securities trading , without most understanding what they were doing. And for those politicians who did understand , $200 million in annual campaign contributions kept potential corrective regulations legislatively frozen."-AVC-3/5/24-
WHAT'S NEXT: A critical mass of poised possibilities could make NWBO stock institutionally investable.
@alphavestcap
alphavestcapital.com
Shibetoshi Nakamoto
@BillyM2k
·Dec 11, 2023
ken griffin of citadel explains how the big hedge funds control the markets and nothing us little peons do matters
https://twitter.com/BillyM2k/status/1734212639306514825…
My understanding is that they will have the machines they need for initial demand in house, ready for use as the equivalency runs are swift and likely approved by the time approval occurs or very soon after as I believe demand will have a slight lag; 1-3 months I’d guesshttps://academic.oup.com/jnci/article/115/11/1262/7241693?login=false
https://jobs.merck.com/us/en/job/R265779/Executive-Director-Discovery-Interface-New-Platforms
https://nice.org.uk/consultations/2523/15/background-nices-transformation
https://nice.org.uk/guidance/indevelopment/gid-pmg10003/consultation/html-content
Video giving further details of NICE's new approach to prioritising guidance including information on 'rare diseases'
Focusing on what matters most: NICE's new approach to prioritising guidance
National Institute for Health and Care Excellence (NICE)
NICE is transforming the way we do things, adopting a new approach to the prioritisation of our guidance. One of the ways NICE is transforming to better serve people and the system is by focusing on what matters most. Hear how we are considering health and care needs based on robust system intelligence. Learn more on how NICE will work with key external stakeholders in? our commitment to make bold decisions to focus on guidance that will make the most impact and address user needs.
Our CMO, Jonathan Benger, delves into our prioritisation approach, highlighting our collaborative efforts with key stakeholders⬇️https://t.co/3K4iOfRHRn
— NICE (@NICEComms) March 5, 2024
https://www.bloomberg.com/news/articles/2024-03-05/confidence-in-uk-as-global-investment-destination-grows-aided-by-ai-lower-taxes?utm_source=twitter&utm_content=business&utm_campaign=socialflow-organic&utm_medium=social&cmpid=socialflow-twitter-business
Bloomberg audio Studios podcasts radio
0:10
news this is the blo Daybreak C podcast
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available every morning on Apple Spotify
0:15
or wherever you listen it's Tuesday the
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5th of March in London I'm Caroline heer
0:20
and I'm Steven Carol coming up today the
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reality is stronger than the sort of
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naysayers would say life's about how you
0:27
do versus expectations isn't it often
0:29
and hopefully 24 will be a year where
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things get better is there a more
0:33
bullish case for Britain's economy wpp's
0:36
CEO Mark Reed is one of the Business
0:38
Leaders who told us he's more optimistic
0:41
we have a special report ahead of the
0:43
Chancellor's budget plus growth on paper
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China sets its GDP expansion Target at
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around 5% as foreign businesses worry
0:53
about a lack of transparency let's start
0:55
with a Roundup of our top stories some
0:58
of Britain's top Business Leaders say
1:00
confidence is returning to the UK after
1:02
years of disruption a two-month
1:04
investigation by Bloomberg Radio found
1:06
London's business Elite increasingly
1:08
upbeat about the future of the economy
1:11
Lloyds of London CEO John Neil told us
1:13
the city is on the right path yeah we've
1:16
seen a wealth of delisting on the
1:18
footsie we've seen real challenges
1:21
around investment and funding in the UK
1:23
we need to get that back on track you
1:25
know part of the livelihood and
1:27
well-being of UK PLC is as a Global
1:30
Financial Services Center I think we're
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starting to get that right but I
1:34
wouldn't say that journey is yet
1:35
complete Neil and other Executives who
1:38
spoken to see the UK as a relative Safe
1:40
Haven ahead of this year's election
1:43
official figures suggest the UK Remains
1:45
the second highest destination globally
1:47
for Greenfield foreign investment after
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the United States China has set its
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growth Target for this year at around 5%
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matching last year's figure despite a
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higher base of comparison the move
2:00
raises expectations for leaders to
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unleash more stimulus to bolster the
2:05
Chinese economy in his first work report
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to the National people's Congress
2:10
Premier Lee Chang acknowledged the
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challenges facing the world's second
2:14
largest economy the external environment
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is more complex severe and uncertain and
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the grow at home is not solid enough and
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the expectation is low and a small and
2:26
the mediumsized enterpris face
2:28
difficulties in their operations
2:30
and we have seen the pressures from
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overall job creation and employment
2:35
problems the Chinese Premier speaking
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through a translator he also announced
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plans to issue 1 trillion one that is
2:42
about $139 billion US of ultr long
2:47
special government bonds in order to
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support what Beijing is calling key
2:51
National
2:52
strategies AMD is at a US Government
2:55
roadblock after trying to sell an AI
2:58
chip tailored for China Bloomberg has
3:00
learned the chipmaker sought America's
3:02
approval for a hand for a
3:04
semiconductor tailored to us export
3:07
restrictions but was rejected the US has
3:10
been working to limit Chinese access to
3:12
cuttingedge semiconductors out of fear
3:14
that Beijing will gain a military Edge
3:18
the dramatic rally in US tech stocks has
3:21
left JP Morgan and Goldman Sachs with
3:23
opposing views as the banks attribute
3:26
the market conditions to different
3:27
drivers to JP Morgan's chief market
3:30
trashes Marco kovich the advances in US
3:33
equities and Bitcoin surge above $60,000
3:36
signal that there is froth in the market
3:39
Goldman sachs's David Coston has argued
3:41
that big Tech valuations are supported
3:44
by fundamentals warranting the risk on
3:46
mood the major gains in the technology
3:49
Giants have driven the S&P 500 Index to
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new highs with the S&P setting 15
3:55
closing records in 2024 so far fueling
3:59
the debate between bulls and bears a
4:01
group of banks bear headed by Morgan
4:03
Stanley has held refinancing talks with
4:05
Elon Musk over debt linked to his
4:07
takeover of the social media platform X
4:10
the talk centered on 12.5 billion
4:12
dollars of debt which supported musk's
4:13
move to take the company private in
4:15
20122 sources have told Bloomberg they
4:18
discussed options to reduce the cost of
4:20
the debt and make it less risky for
4:22
banks to hold the seven lers have
4:24
repeatedly renewed an agreement not to
4:26
offload their Holdings until the social
4:28
media platform is on a firmer Financial
4:30
footing the US Supreme Court has ruled
4:33
that Donald Trump can appear on
4:35
presidential ballots the decision comes
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after Nationwide efforts to ban him
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citing a constitutional provision
4:42
preventing insurrectionists from holding
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office the Colorado Supreme Court's
4:47
earlier decree against Trump's right to
4:49
run for a second presidential term was
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overturned unanimously the former
4:54
president said the result was a
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milestone I think it's a very big day
4:58
for America I think it's a very big day
5:01
for Liberty and I think it's a just a
5:04
great day for this country Donald Trump
5:07
speaking there his Republican opponent
5:09
Nikki Haley also praised the move I'll
5:12
defeat Donald Trump fair and square but
5:14
I want him on that
5:16
[Applause]
5:19
balance Nikki Haley is trailing Donald
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Trump by 64 points in National polls
5:24
ahead of today's super Tuesday primary
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votes in 15 us
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States now we're just a day away from
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the budget here in the UK a moment when
5:33
the public finances and economic outlook
5:35
for Britain are a subject of national
5:37
conversation business and consumer
5:39
confidence are key to the UK's success
5:42
so after a rocky few years are things
5:45
improving Carline you've been taking the
5:46
temperature with footsy 100 CEOs and
5:48
chairs ahead of tomorrow's announcements
5:50
from the chancellor and asking them if
5:52
there's a more positive case to be made
5:54
for Britain yeah the the thought around
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this was that last year was such a
5:59
difficult year for Britain and I did a
6:01
long print and radio piece in April
6:04
called Britain a drift you know whether
6:06
the economy was a drift and sort of
6:08
uninvestable in Britain Microsoft's Brad
6:10
Smith if you remember he said that the
6:12
EU was a better place to do business at
6:15
the time that really stung and then
6:17
there were other criticisms from Dyson
6:19
and Astro zenica and many quite loud
6:22
plus the arm uh vote to list in the US
6:25
not in London that really um rattled a
6:28
lot of people I think 10 months later
6:31
though the data and the mood does seem
6:34
to have changed quite significantly
6:36
economists and Business Leaders have
6:38
moved on and so for example wpp's Mark
6:42
Reed telling me that he is more hopeful
6:44
about 2024 being a year where things are
6:47
going to go get better as they go along
6:49
unlike 2023 Simon Carter the CEO of
6:52
British land saying that he's cautiously
6:55
optimistic barenburg and Deutsche Bank
6:57
economists pointing to the resilience of
6:59
the the UK the Silver Linings of the UK
7:02
and a host of other CEOs really sounding
7:04
a lot more confident welcoming some of
7:06
the government initiatives looking ahead
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to the election year that's going to be
7:10
so important so yes as you say went out
7:14
and did a number of big interviews with
7:16
5100 CEOs and chairs over the last few
7:19
weeks major UK businesses here is the
7:23
result have a
7:28
listen
7:30
in the UK you learn to love the weather
7:32
you have to but when the economy has
7:34
been as clouded over as it has been
7:36
recently you start to long for any
7:39
glimmer of sunshine last year it was a
7:42
drizzly day when I spoke to the marks
7:44
and Spencer chairman Archie Norman at
7:47
the company's head office in Paddington
7:49
the drizzle rather matched his mood at
7:52
the time he was deeply concerned about
7:55
post brexit Britain since then we know
7:58
the UK's gone into recession so with
8:01
that in mind and the rain of course
8:03
still coming down I asked if his
8:06
forecast is just as downbeat when you're
8:10
running a business like M&S our
8:13
philosophy is we row our own boat you
8:15
know and and the seas are choppy or the
8:17
seas are calm but we our job is to make
8:20
the boat go faster actually our success
8:22
is more to do with how successful we are
8:24
in reshaping M&S and what happens in the
8:26
market and um you know we've had
8:29
a decent run but there's a l long long
8:31
way further to go while Norman puts the
8:34
success of Marx and Spencer down to the
8:37
way that it's run he does see light on
8:39
the horizon for the consumer and that
8:42
will help his business and many others
8:45
very importantly wages are now Rising
8:49
faster than inflation faster than prices
8:51
so people are genuinely better off on
8:55
average from the iconic British retailer
8:58
to one of the country's largest pension
9:00
providers legal and general Investment
9:03
Management manages pensions for 5
9:06
million people Michelle scrimo is the
9:09
CEO it's easier to focus on the
9:11
challenges when you're looking outside
9:12
the window of our UK headquarters and
9:14
it's raining down and it's a gray day
9:17
here in London actually the UK has been
9:22
an amazing home for legal and general
9:24
for over 180 years but what of this year
9:27
or next year will the UK see significant
9:30
improvements in growth and wealth so if
9:34
you think about where the world is today
9:36
there is a lot of uncertainty there is
9:39
geopolitical uncertainty there is
9:40
uncertainty around interest rates we're
9:43
no different in the UK we're part of
9:46
that big ecosystem but if I think about
9:49
where things could go better for sure
9:52
we're still in a postco environment
9:54
we're still in a in a post energy crisis
9:57
environment that is isn't going away it
10:01
is working through so as things work
10:03
through there is certainly an
10:05
opportunity for interest rates to come
10:07
down yes we're in a technical recession
10:10
but as rates come down and that frees up
10:14
more capital and it actually has an
10:17
impact on individuals and where they are
10:21
because don't forget this is there a
10:22
cost of living challenge here at an
10:24
individual level not just an economic
10:27
challenge for the country I do think
10:29
there is opportunity El Jim's Michelle
10:31
scrimo seeing opportunities so is it the
10:35
start of a more bullish British economy
10:38
to know that you also have to get at the
10:40
heart of what drives economic sentiment
10:43
for a large slice of the UK the property
10:47
[Music]
10:49
Market if mon trates do go much higher
10:52
than yeah that that would almost
10:53
certainly become a
10:55
[Music]
10:57
problem property price prices fell in
11:00
July at their fastest Pace since the
11:01
global financial crisis for the third
11:04
month in a
11:07
row the housing market is on track to
11:10
see the lowest level of home sales since
11:12
[Music]
11:18
2012 but although house prices declined
11:21
last year they avoided predictions of a
11:24
collapse and while office rents in the
11:27
US fell in the UK that was not the case
11:31
British land CEO Simon Carter told me
11:34
he's now hopeful for us what really
11:37
matters is unemployment if people have
11:40
money in their pocket they spended our
11:42
retail assets I think it's encouraging
11:44
that we might see real wage growth that
11:48
helps because we haven't seen a lot of
11:49
that uh and similarly when we're leasing
11:52
office space what matters is we do top
11:56
end office space and it's headquarters
11:59
space where businesses are using it to
12:01
attract and retain talent and of course
12:03
they want to attract and R retain Talent
12:06
when unemployment is low so I think if
12:08
we can see a situation where
12:10
unemployment remains relatively low the
12:12
economy grows a little bit and we see a
12:15
bit of real wage growth the momentum
12:17
that we've seen over the last couple of
12:19
years can continue because that's been
12:20
the odd thing in the property Market
12:23
that the investment Market because of
12:25
higher interest rates has struggled but
12:27
actually occupationally it's been very
12:29
good and people have taken space so
12:32
momentum in the right direction but what
12:34
about some acceleration to get that you
12:37
need to tap into the buzzword on every
12:40
CEO's lips AI is going to be important
12:44
we believe we're excited about it we're
12:46
addressing some of the most profound
12:48
Social Challenges with AI in ways that
12:51
are transformative AI is going to change
12:53
the nature of jobs we believe that AI uh
12:57
is the most Prof found opportunity uh in
13:00
our lifetimes you heard Executives
13:02
mention the word AI about 50
13:07
times advertising giant wpp's CEO Mark
13:11
Reed is focused on the benefits this
13:15
once in a generation technology could
13:17
deliver for Britain I I I think it's a
13:20
massive opportunity for us I mean at one
13:22
level you could say well of a large
13:23
language models they're all being
13:24
created in America but actually what
13:27
what you can do with a I is get access
13:30
to these models extremely cheaply you
13:32
know we're not investing billions of
13:34
dollars at wpp and a we can't afford it
13:36
but we are using the models created by
13:38
open Ai and Microsoft and Google and
13:40
others to power our work and so it's
13:43
really about the application of
13:45
technology and as you say because we're
13:46
a service-based economy it could make
13:48
our service structure much much more
13:51
productive much much more efficient and
13:52
I just think we have to lean into it and
13:55
embrace it wpp is planning to spend
13:58
about £ 250 million a year on AI
14:02
technology Microsoft is investing 25
14:05
billion pounds in UK AI data centers
14:09
over three years and the government says
14:12
that it wants Britain to be focused on
14:14
reaping the rewards from the AI Gold
14:17
Rush here's the Deputy Prime Minister
14:20
Oliver Dowden speaking to Bloomberg at
14:23
last year's AI Summit if you think about
14:26
how financial services and the City of
14:28
London have so enriched the United
14:31
Kingdom over the past generation or two
14:34
I'm convinced that AI can do the same
14:36
thing for the UK over generations to
14:38
come so the government is persuaded of
14:40
the benefits of artificial
14:42
intelligence but John Neil the CEO of
14:46
Lloyds of London says better performance
14:49
also needs political stability I think
14:53
we all need the confidence of a two-term
14:56
government what whatever that government
14:58
is because I think the issues that we're
15:00
grappling with you know and the need for
15:02
confidence and the lack of the
15:04
confidence that whether it's the public
15:06
or whether it's business we just need
15:08
the sense that there is a plan and that
15:11
plan is going to have to stretch Beyond
15:13
one term of government so I would say we
15:15
need change and I'm not saying that has
15:18
to be a labor government versus a
15:19
conservative government we do need to
15:21
change we cannot carry on the way we are
15:24
and he's concerned that even with the
15:26
attempts by the big political parties to
15:29
woo the city too much is still being
15:32
taken for granted our advantage in
15:35
insurance is the only Marketplace for
15:37
insurance in the world is here there
15:39
isn't another one and and I think we are
15:41
standing up and representing the best of
15:43
that or doing our best to illustrate how
15:45
that value can be we're growing we're
15:48
we're profitable we need to be
15:49
profitable if we're going to innovate
15:51
and reinvest in what the future looks
15:52
like I don't think the same is quite
15:55
true everywhere in financial services
15:57
now we've seen a wealth of delisting on
16:00
the footsy we've seen real challenges
16:02
around investment and funding in the UK
16:04
we need to get that back on track you
16:06
know part of the livelihood and
16:08
well-being of UK PLC is as a Global
16:11
Financial Services Center there's a lot
16:13
of ground to make up even with the
16:15
chancellor Jeremy Hunt's mansion house
16:17
reforms the 5100 has lagged Global
16:21
markets since 2018 investors pulled a
16:24
record $29 billion from UK Equity Funds
16:29
last year and Europe's Tui announced
16:32
recently it will delist from
16:35
London those numbers are not lost on
16:38
other CEOs we spoke to here's wpp's Mark
16:42
Reed again I've learned as CEO never
16:46
really to comment on our share price but
16:49
I mean you can but look at your
16:51
valuation relative to your peers in
16:52
other markets and think you know there
16:54
are some possible attractions to being
16:57
in the US though I think the
16:58
complexities of it make it very
17:00
difficult really in reality for for most
17:02
companies and what we really need to do
17:04
is get UK Pension funds investing back
17:07
in the UK Market because you know
17:10
ultimately you know we have a sizable
17:12
stock market and if it's not being
17:14
supported by UK uh Pension funds you
17:18
know why why would International Pension
17:19
funds support
17:22
us so the UK economy is still under a
17:25
cloud and no one expects rapid growth
17:29
tomorrow but there is hope that it could
17:32
stop being rained on and at last enjoy
17:36
some
17:39
sunshine okay well fittingly Caroline
17:42
this morning there's no rain outside the
17:43
sun is just about Rising outside in the
17:46
city uh of London so much to unpack in
17:49
this report lots of really key voices
17:51
from very diverse Industries across the
17:53
UK economy put this in perspective for
17:56
us how much is confidence improving
18:00
what's driving that so I think it's
18:03
first and foremost inflation coming down
18:05
that was a big issue last year also the
18:07
possibility of interest rate Cuts all of
18:08
those CEOs were talking about those as
18:10
two main drivers plus wages going up and
18:13
they have gone up um for six months now
18:16
so that's massively important um
18:18
Bloomberg economics thinks that the
18:20
economy in the UK could grow by 1% this
18:22
year but
18:24
1.9% if consumers feel more confident
18:27
and spend their savings things that
18:28
would be a big difference so you heard
18:30
from the marks and Spencer chair Archie
18:32
Norman there saying people are genuinely
18:34
better off on average um so that sort of
18:38
gets past the technical recession that
18:41
we saw at the end of last year maybe
18:42
that's the worst of it more long-term
18:45
business investment is up 6.1% year
18:48
on-year in 2023 and artificial
18:51
intelligence is already being adopted
18:54
across businesses like M&S but also like
18:57
wpp that could really improve one of the
19:00
main long-term weak spots and that is UK
19:03
productivity so Mark we saying it's
19:05
already seeing 20 to 25% improvements in
19:09
productivity for some of their people
19:11
and I also spoke to Matt Clifford who
19:13
created the prime minister's artificial
19:15
intelligence safety Summit last year and
19:18
I mean you don't get more bullish than
19:19
him yeah I mean this is also an election
19:22
year and this is part of the
19:23
conversation that you were having with
19:24
these Business Leaders too are they warm
19:27
about care F La labor party of course
19:29
leading in the polls yes I can't say
19:31
that they're not what they want though
19:34
is consensus on growth something that a
19:37
lot of them do see they want long-term
19:40
policymaking I was surprised by how
19:43
often this idea of having a two-term
19:45
government came up for Business Leaders
19:47
um Archie Norman's saying you have to
19:49
have a 10-year consistent approach
19:52
everyone recognizes this problem of how
19:54
you rekindle growth now also the fact
19:57
that they are really two centrists in K
20:01
starma and rishy sunak vying for power
20:03
and that is quite reassuring Lloyds of
20:05
London CEO John Neil said that you need
20:07
the confidence as you as you just heard
20:09
there of a two-term government and then
20:11
you do see things like British land
20:13
joining the labor Le building back
20:16
Britain commission for example but I
20:19
think legal and general investment
20:20
Management's Michelle scrimo kind of put
20:22
it quite neatly it's less about politics
20:25
it is more about in her words stability
20:28
Clarity and consistency so there still
20:31
is a long way to go for Britain but is
20:33
there a Gap too between investors and
20:36
these Business Leaders perhaps quite
20:39
sobering because along with this deep
20:41
dive reporting that I did with my
20:43
colleague in print Philip audrick we
20:45
also put out one of our regular mive
20:48
surveys of investors on the Bloomberg
20:50
terminal and we asked them this question
20:53
do you think the living standards in the
20:54
UK in 5 years time are going to go up go
20:57
down or stay the same out of 463
21:00
investors that we surveyed
21:03
48% said that they expected living
21:05
standards in the UK to decline versus G7
21:09
peers over 5 years 35% no change only
21:13
177% said that British living standards
21:15
would improve that is you know pretty
21:19
sobering stuff surely that is something
21:21
that the UK has to improve got to
21:24
improve confidence inward investment and
21:26
so many other points you know to make
21:28
the kind of slightly brighter economic
21:31
picture a much more decisive reality
21:35
okay well this is part of our special
21:37
featuring of this reporting on the
21:39
bullish case for Britain you can read
21:41
more on the Bloomberg terminal and on
21:43
the Bloomberg website with piece by our
21:45
colleague philli
21:48
alri this is Bloomberg Daybreak Europe
21:50
your morning brief on the stories making
21:52
news from London to Wall Street and
21:54
Beyond look for us on your podcast feed
21:57
every morning on on Apple Spotify and
21:59
anywhere else you get your podcasts you
22:01
can also listen live each morning on
22:03
London dab radio the Bloomberg business
22:05
app and bloomberg.com our Flagship New
22:08
York station is also available on your
22:10
Amazon Alexa devices just say Alexa play
22:13
Bloomberg 11:30 I'm Caroline Hep and I'm
22:16
Steven Carol join us again tomorrow
22:18
morning for all the news you need to
22:19
start your day right here on Bloomberg
22:22
Daybreak
22:24
[Music]
22:26
ken griffin of citadel explains how the big hedge funds control the markets and nothing us little peons do matters pic.twitter.com/fpRtyJpjLN
— Shibetoshi Nakamoto (@BillyM2k) December 11, 2023
learningcurve2020:1) annual spoofing profits, 2) fees-campaign contributions to politicians, 3) nwbo naked short position,4) payments to refugators, 5) payments to Russia and China for algorithm design, 6) locations of Citadel computers adjacent to exchanges, 7)what else?
Re: Inquirig post# 675874
Sunday, March 03, 2024 1:02:20 PM
Post#
675882
of 675902
Would that be revealed through discovery, do you think?
"NWBO intends to refile its complaint within days. This time around, if a judge finds the deficiencies in the biotech’s case have been fixed, it could pave the way for the so-called discovery process in which Citadel Securities and its co-defendants would be compelled to hand…
— alphavestcapital.com (@alphavestcap) March 2, 2024
In the past three years, have the NYT, FT, and WSJ written in NWBO?
Today’s FT $NWBO & spoofing! pic.twitter.com/WUphDLODAt
— Richard Fairgrieve (@RichFairgrieve) March 2, 2024
https://www.ft.com/content/4fe0f032-07e5-41d7-ac85-cceb252129a3
can someone please post this FT article on the lawsuit?
Today’s FT $NWBO & spoofing! pic.twitter.com/WUphDLODAt
— Richard Fairgrieve (@RichFairgrieve) March 2, 2024
https://t.co/lAvuXD2Ord @alphavestcap $nwbohttps://t.co/cgL7Feb9VV
— alphavestcapital.com (@alphavestcap) March 1, 2024
Smitty5150
Re: CaptainObvious post# 675405
Friday, March 01, 2024 8:18:15 AM
Post#
675408
of 675410
https://www.parliament.uk/site-information/glossary/ten-minute-rule-bill
There were NO opposing speeches, and this bill has cross party support. This bill
will pass
https://en.m.wikipedia.org/wiki/Ten_Minute_Rule
Member Level
Re: flipper44 post# 674670
Friday, March 01, 2024 8:00:54 AM
Post#
675404
of 675411
Recent movement. (Update)
1. Combination patent application in Europe to be granted, includes both DCVax-l (lysate pulsed) and/or DCVax-Direct (partial maturation) with checkpoint inhibitors.
2. 72 days since MAA was filed.
3. MHRA and FDA looking at further cooperation.
4. Nature Journal article on DC/poly-iclc combination study nearing publication. Primary completion date for study occurred nearly thirty days ago.
5. Active negotiations with other parties for combination trials going on for over a year, awaiting MAA to be “cemented.”
6. Large pharma struggling to adapt to upcoming patent cliffs.
7. Cohen/Milstein/Posner about to file second amended complaint, and with it, formulaic method to arrive at loss causation.
8. Flaskworks (aka: NWBO) continues IP momentum.
9. Advent hiring head of production to hire team to facilitate biotherapeutic production for clinical use. (Direct?)
10. FDA pursuing Promising Pathways.
11. Apparently NICE has been working with NWBO recently, and it anticipates an update on the topic website in the next week or so.
12. The End Brain Cancer Initiative (EBCI) Advocates for DCVax®-L to Gain FDA Approval
13. 10 Minute Rule Bill passed in UK for the 3,200 people who are diagnosed with a glioblastoma brain tumour every single year
https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/united-kingdom/amp
The NHS ring-fences funding for certain classes of medicine that receive a particular type of recommendation from NICE.
The Cancer Drugs Fund (“CDF”) is in place to enable faster access to promising new cancer treatments. Following its relaunch in 2016, the CDF aims for all new systemic cancer drugs to receive a fast-tracked NICE appraisal. So far, 102 new oncology drugs treating 242 different indications have been through CDF review. NICE will recommend a product to receive funding from the CDF, at a negotiated price, if it has the potential to satisfy the criteria for routine commissioning but there is clinical uncertainty that needs further investigation (i.e., through data collection in the NHS or clinical studies). The drug will remain available within the CDF while more evidence becomes available, at which point NICE will subject it to one of its standard technology appraisal processes. The CDF has provided a route to NHS funding for a number of highly innovative, high-cost oncology technologies, including CAR-T and certain immuno-oncology therapies. The NHS has guaranteed £340 million per year for the CDF.
Introduced in 2022, the Innovative Medicines Fund (“IMF”) is an analogue to the CDF for non-oncology medicines that show significant clinical promise but for which the evidence base may be immature or uncertain. The primary function of the IMF is to provide managed, interim access to a promising medicine to patients while further evidence is generated to support a full NICE assessment. As with the CDF, the NHS has guaranteed £340 million per year for the IMF.
Improving, indispensable transcript.Thank You. Joe Pratt (aekusterer) jhpratt@alphavestcapital.com
Dame Siobhain McDonagh's bill passed. With this, the U.K. appears legislating dc vax l into its dendritic cell cancer immunotherapy healthcare system for all citizens , and in doing so, potentially establishing the U.K. as the world leader in delivering superior cancer…
— alphavestcapital.com (@alphavestcap) March 1, 2024
📜Today I passed my 10 Minute Rule Bill for the 3,200 people who are diagnosed with a glioblastoma brain tumour every single year...
— Siobhain McDonagh MP (@Siobhain_Mc) February 28, 2024
Thank you to @wesstreeting and @willquince for your cross party support pic.twitter.com/x4kepaGAD2
https://t.co/0LTLYKpxbQ $nwbo @alphavestcap https://t.co/YkfjOTGgiVhttps://t.co/OQU4XTi7Eghttps://t.co/ugXAyPPUvR
— alphavestcapital.com (@alphavestcap) February 28, 2024
"I’m only speculating here, but it would be a great surprise to hear something from NICE next week and then soon after MAA approval by end of March to middle… pic.twitter.com/s00LOA7hG4
Dame Siobhain McDonagh =backing little biotech:
— alphavestcapital.com (@alphavestcap) March 1, 2024
"to require manufacturers of drugs licensed to treat tumours to make those drugs available in specified circumstances for clinical trials relating to brain tumours."https://t.co/p6w9BF1iRP@alphavestcap $nwbo
2),"I will give just…
📜Today I passed my 10 Minute Rule Bill for the 3,200 people who are diagnosed with a glioblastoma brain tumour every single year...
— Siobhain McDonagh MP (@Siobhain_Mc) February 28, 2024
Thank you to @wesstreeting and @willquince for your cross party support pic.twitter.com/x4kepaGAD2
https://t.co/oJ8aizxnxp $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) February 29, 2024
transcript available for non uk streamers?
https://hansard.parliament.uk/Commons/2024-02-28/debates/06FFF455-79DA-4313-B11A-
Full text of Brain Tumours bill
Volume 746: debated on Wednesday 28 February 2024
Dame Siobhain McDonagh
(Mitcham and Morden) (Lab)
Sharethis specific contribution
I beg to move,
That leave be given to bring in a Bill to set a target for the number of glioblastoma patients who take part in clinical trials each year; to require training for medical oncologists to include training relating to brain cancers; to provide that any drug that has been licensed for use on tumours must be trialled on people with brain tumours; to make provision in relation to neuro-oncology multidisciplinary teams in the NHS, including a requirement that each such team must include a medical oncologist; to require manufacturers of drugs licensed to treat tumours to make those drugs available in specified circumstances for clinical trials relating to brain tumours; to make provision about the application of funding caps on funding for multi-drug treatments for glioblastoma brain tumours; to make provision about the processes for funding of drugs intended for the treatment of glioblastoma; to make provision about the management of drug trial data, for the purpose of increasing the quality of data relating to glioblastoma patients; to make provision about reviewing the allocation of existing funding for brain tumour research by the National Institute for Health and Care Research; to make provision about the direct referral of patients by optometrists to accident and emergency departments for the purpose of diagnosing brain tumours; and for connected purposes.
The reason I am speaking again about this terrible disease is a personal one. It is why this campaign will always feel different from the other campaigns I take on. On 24 June 2023, I lost my wonderful sister Margaret to a glioblastoma brain tumour. As soon as Margaret received her diagnosis, we found out just how bad the treatment was, how the life expectancy was nine months and how there had not been a new treatment on the NHS for 30 years. We found out that families in the UK were left to crowdfund and sell their houses to fund private treatment, and that they would have to take their very sick family member on to a plane and fly thousands of miles to access healthcare in Germany or the United States. That is why Margaret started her final campaign: to find a cure for glioblastoma brain tumours. When Margaret passed away on 24 June, it was left to me to take on that battle. Her mission is now my mission. The Government have left the disease in the “too difficult” pile for too long, and I am here to put finding a cure back on the Government’s agenda.
The second reason I am making this speech is above us in the viewing Gallery: I am incredibly grateful that a number of patients’ families have come to the House to hear the speech, and their support is a reminder that 3,200 people are diagnosed with a glioblastoma brain tumour every year. It is not just Margaret who was forced to fly thousands of miles to access the treatment that should have been provided on the NHS, but families up and down the country who are being failed and who deserve better. Having cared for someone with a brain tumour, I know how bad things are, and I know that if we try something different, we can give people diagnosed with this deadly disease some hope. This is my something different.
No. 1 is the pharmaceutical industry. Dr Paul Mulholland is Europe’s leading medical oncologist in glioblastoma. He believes that we are on the cusp of a cure and he would like to run clinical trials so that he can turn that belief into a reality, but the pharmaceutical industry has refused to donate the drugs he needs for those trials Toggle showing location ofColumn 370to take place. That is because glioblastoma is a very small market for those companies. With only 3,200 people diagnosed each year, the investment is just not profitable —there is not much money in it, and the companies are not interested. That is why, as policymakers, it is our job either to encourage or to force the pharmaceutical companies to provide the drugs for these trials.
I will give just one example. In October, I met Moderna to ask if it could donate medicines for a clinical trial of 10 patients. I had hoped that it would give clinical access to its mRNA pipeline to help find a cure, but it refused. This company with annual sales of $4 billion refused to donate drugs for 10 people at a maximum cost of half a million pounds. These drugs could save thousands of lives each year, so Moderna’s refusal is shameful.
The House will be interested to hear that Moderna has published an environmental, social and governance statement on its website that says it has
“a responsibility to the multitude of patients our technology could help, regardless of whether they have a disease shared by millions, or one that is unique to them alone.”
The statement says that Moderna
“understand what our stakeholders expect from us as a sustainable responsible business and leader in mRNA medicines.”
Those words are clearly meaningless.
I do not mean to sound pessimistic, because some companies have been very supportive—I have had wonderful conversations with Roche—but where companies such as Moderna have the funds and the medicines but lack the will to find a cure for brain tumours, I think it is the Government’s duty to step in and legislate to ensure that they do.
The second difference is about regulation. We need to ensure that our regulators incentivise the pharmaceutical industry and clinicians to do as many clinical trials as possible. Right now, the pharmaceutical industry sees the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence as a barrier, as a reason not to do clinical trials in the UK. That needs to change. For starters, when a pharmaceutical company is trialling a drug for glioblastoma and another disease such as melanoma, the MHRA should allow it to submit its data separately, so that glioblastoma patients’ results do not adversely affect the application.
Funding treatments as a package has been a major impediment to the industry. We can solve this issue if NICE funds each drug used in the treatment of glioblastoma separately. We will make progress if we make those changes, but we should not stop there. We need a whole host of policy changes if we want to make a change. If we carry on with the same old processes, we will get the same old results, which in the case of brain tumour research is failure. We also need a target of getting 200 glioblastoma patients each year into clinical trials on drugs that have the potential to change the course of the disease.
We need the NHS to ensure that every neuro-oncology multidisciplinary team has a medical oncologist as a core member, so that brain tumour patients are not left in a corner of the ward because there is nobody to fight for them. The NHS should make it easier for optometrists to directly refer patients straight to A&E for a scan without going through their GP.
On Monday I met the Anticancer Fund, which is based in Brussels, and I think I have discovered the one Toggle showing location ofColumn 371benefit of Brexit. Brexit means that the NHS medicines repurposing programme has been able to identify drugs that were initially purposed to cure another cancer, and that is exactly what we need to tackle brain tumours.
The NHS should require that every doctor training to be a medical oncologist goes through a mandatory course on brain tumours, which takes me to my final recommendation. In 2018, after Tessa Jowell sadly passed away from glioblastoma, £40 million of Government funding was promised to fund research into brain tumours. As of January 2024, just £15 million of that £40 million had been awarded. That is a real failure of government. The MHRA should be shouting loud and proud about how much money is available for investment in brain tumour treatments, but it does not and I cannot understand why.
For as long as there is no progress and I am a Member, I will come back to the House at every opportunity. I came into politics to fight for people who are not heard, and there are few people heard less than those who suffer from glioblastoma.
Question put and agreed to.
Ordered,
That Dame Siobhain McDonagh, Will Quince, George Freeman, Tracey Crouch, Steve Brine, Helen Hayes, Paul Blomfield, Sarah Owen, Dame Meg Hillier, Daisy Cooper and Wes Streeting present the Bill.
Dame Siobhain McDonagh accordingly presented the Bill.
Bill read the First time; to be read a Second time on Friday 19 April, and to be printed (Bill 169).
Mr Deputy Speaker
(Mr Nigel Evans)
Sharethis specific contribution
Your campaign is one of Margaret’s legacies. Thank you, Siobhain.
https://hansard.parliament.uk/Commons/2024-02-28/debates/06FFF455-79DA-4313-B11A-2AFFFA52D940/BrainTumours
https://hansard.parliament.uk/Commons/2024-02-28/debates/06FFF455-79DA-4313-B11A-
Full text of Brain Tumours bill
Volume 746: debated on Wednesday 28 February 2024
Dame Siobhain McDonagh
(Mitcham and Morden) (Lab)
Sharethis specific contribution
I beg to move,
That leave be given to bring in a Bill to set a target for the number of glioblastoma patients who take part in clinical trials each year; to require training for medical oncologists to include training relating to brain cancers; to provide that any drug that has been licensed for use on tumours must be trialled on people with brain tumours; to make provision in relation to neuro-oncology multidisciplinary teams in the NHS, including a requirement that each such team must include a medical oncologist; to require manufacturers of drugs licensed to treat tumours to make those drugs available in specified circumstances for clinical trials relating to brain tumours; to make provision about the application of funding caps on funding for multi-drug treatments for glioblastoma brain tumours; to make provision about the processes for funding of drugs intended for the treatment of glioblastoma; to make provision about the management of drug trial data, for the purpose of increasing the quality of data relating to glioblastoma patients; to make provision about reviewing the allocation of existing funding for brain tumour research by the National Institute for Health and Care Research; to make provision about the direct referral of patients by optometrists to accident and emergency departments for the purpose of diagnosing brain tumours; and for connected purposes.
The reason I am speaking again about this terrible disease is a personal one. It is why this campaign will always feel different from the other campaigns I take on. On 24 June 2023, I lost my wonderful sister Margaret to a glioblastoma brain tumour. As soon as Margaret received her diagnosis, we found out just how bad the treatment was, how the life expectancy was nine months and how there had not been a new treatment on the NHS for 30 years. We found out that families in the UK were left to crowdfund and sell their houses to fund private treatment, and that they would have to take their very sick family member on to a plane and fly thousands of miles to access healthcare in Germany or the United States. That is why Margaret started her final campaign: to find a cure for glioblastoma brain tumours. When Margaret passed away on 24 June, it was left to me to take on that battle. Her mission is now my mission. The Government have left the disease in the “too difficult” pile for too long, and I am here to put finding a cure back on the Government’s agenda.
The second reason I am making this speech is above us in the viewing Gallery: I am incredibly grateful that a number of patients’ families have come to the House to hear the speech, and their support is a reminder that 3,200 people are diagnosed with a glioblastoma brain tumour every year. It is not just Margaret who was forced to fly thousands of miles to access the treatment that should have been provided on the NHS, but families up and down the country who are being failed and who deserve better. Having cared for someone with a brain tumour, I know how bad things are, and I know that if we try something different, we can give people diagnosed with this deadly disease some hope. This is my something different.
No. 1 is the pharmaceutical industry. Dr Paul Mulholland is Europe’s leading medical oncologist in glioblastoma. He believes that we are on the cusp of a cure and he would like to run clinical trials so that he can turn that belief into a reality, but the pharmaceutical industry has refused to donate the drugs he needs for those trials Toggle showing location ofColumn 370to take place. That is because glioblastoma is a very small market for those companies. With only 3,200 people diagnosed each year, the investment is just not profitable —there is not much money in it, and the companies are not interested. That is why, as policymakers, it is our job either to encourage or to force the pharmaceutical companies to provide the drugs for these trials.
I will give just one example. In October, I met Moderna to ask if it could donate medicines for a clinical trial of 10 patients. I had hoped that it would give clinical access to its mRNA pipeline to help find a cure, but it refused. This company with annual sales of $4 billion refused to donate drugs for 10 people at a maximum cost of half a million pounds. These drugs could save thousands of lives each year, so Moderna’s refusal is shameful.
The House will be interested to hear that Moderna has published an environmental, social and governance statement on its website that says it has
“a responsibility to the multitude of patients our technology could help, regardless of whether they have a disease shared by millions, or one that is unique to them alone.”
The statement says that Moderna
“understand what our stakeholders expect from us as a sustainable responsible business and leader in mRNA medicines.”
Those words are clearly meaningless.
I do not mean to sound pessimistic, because some companies have been very supportive—I have had wonderful conversations with Roche—but where companies such as Moderna have the funds and the medicines but lack the will to find a cure for brain tumours, I think it is the Government’s duty to step in and legislate to ensure that they do.
The second difference is about regulation. We need to ensure that our regulators incentivise the pharmaceutical industry and clinicians to do as many clinical trials as possible. Right now, the pharmaceutical industry sees the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence as a barrier, as a reason not to do clinical trials in the UK. That needs to change. For starters, when a pharmaceutical company is trialling a drug for glioblastoma and another disease such as melanoma, the MHRA should allow it to submit its data separately, so that glioblastoma patients’ results do not adversely affect the application.
Funding treatments as a package has been a major impediment to the industry. We can solve this issue if NICE funds each drug used in the treatment of glioblastoma separately. We will make progress if we make those changes, but we should not stop there. We need a whole host of policy changes if we want to make a change. If we carry on with the same old processes, we will get the same old results, which in the case of brain tumour research is failure. We also need a target of getting 200 glioblastoma patients each year into clinical trials on drugs that have the potential to change the course of the disease.
We need the NHS to ensure that every neuro-oncology multidisciplinary team has a medical oncologist as a core member, so that brain tumour patients are not left in a corner of the ward because there is nobody to fight for them. The NHS should make it easier for optometrists to directly refer patients straight to A&E for a scan without going through their GP.
On Monday I met the Anticancer Fund, which is based in Brussels, and I think I have discovered the one Toggle showing location ofColumn 371benefit of Brexit. Brexit means that the NHS medicines repurposing programme has been able to identify drugs that were initially purposed to cure another cancer, and that is exactly what we need to tackle brain tumours.
The NHS should require that every doctor training to be a medical oncologist goes through a mandatory course on brain tumours, which takes me to my final recommendation. In 2018, after Tessa Jowell sadly passed away from glioblastoma, £40 million of Government funding was promised to fund research into brain tumours. As of January 2024, just £15 million of that £40 million had been awarded. That is a real failure of government. The MHRA should be shouting loud and proud about how much money is available for investment in brain tumour treatments, but it does not and I cannot understand why.
For as long as there is no progress and I am a Member, I will come back to the House at every opportunity. I came into politics to fight for people who are not heard, and there are few people heard less than those who suffer from glioblastoma.
Question put and agreed to.
Ordered,
That Dame Siobhain McDonagh, Will Quince, George Freeman, Tracey Crouch, Steve Brine, Helen Hayes, Paul Blomfield, Sarah Owen, Dame Meg Hillier, Daisy Cooper and Wes Streeting present the Bill.
Dame Siobhain McDonagh accordingly presented the Bill.
Bill read the First time; to be read a Second time on Friday 19 April, and to be printed (Bill 169).
Mr Deputy Speaker
(Mr Nigel Evans)
Sharethis specific contribution
Your campaign is one of Margaret’s legacies. Thank you, Siobhain.
https://hansard.parliament.uk/Commons/2024-02-28/debates/06FFF455-79DA-4313-B11A-2AFFFA52D940/BrainTumours
what was the date of atnm's crl letter?
Lykiri:Are there transcripts or videos available for Dr.Brem's several presentations at this comference ? A.E.K.
https://www.med.upenn.edu/brain2024/agenda.html
Flipper:
Friday, January 26, 2024 3:44:30 PM
Good DD‼️ This effectively means the validation is confirmed and reverts back to December 20, 2023. Imo.
CHM meeting still March 20/21, 2024. Imo.
So, I’d move up all of Hoffman’s dates by 15 days. Imo.
This also means they received accelerated review! Imo.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173713303
🤔Speculative #DCVax-L Approval Timelines🤔
$NWBO
On December 20, 2023, Northwest Biotherapeutics, Inc. (NWBO) submitted their Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) requesting to be reviewed under the MHRA’s rapid 150-day review pathway. [1]
What is the MHRA's rapid 150-day review pathway?
MHRA guidance states, in relevant part:
“The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK.” [2]
The assessment timeline can be broken down into three parts:
Phase 1?: Up to 80 Days (clock on)
“Assessment phase I will be completed 80 days after the clock starts.” Id.
Interim Phase: 60 days, more or less (clock off)
“Issues arising or 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 only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. ” Id.
Phase 2?: 150 days minus Phase 1 timeline (clock on)
“Phase two assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings." Id.
When does the 150 day assessment start?
Upon validation per MHRA guidance:
“The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.” Id.
When was $NWBO's MAA validated by the MHRA?
Lets look at some emails that were disclosed in the derivative lawsuit to help us shed light on this question. I have not provided cites or screenshots of these documents as they are behind a paywall. The Delaware case number is: 2022-1093-JTL.
January 2, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
“Over the next three months, the Company will be preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information. Our clients are heavily involved with that process every step of the way. I will be happy to provide more detail on what that process will entail during today’s call.”
January 4, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
“I have also received confirmation that all of the Company’s senior management, including Ms. Powers and Mr. Goldman, will be devoting substantially all of their time to the inspection process over the next three months.” (emphasis added)
What do these emails tell us?
It appears NWBO’s MAA was validated on, or before, January 4th, 2024 as the company confirmed that “substantially all of their time” will be devoted to the “inspection process”.
These emails also point out that NWBO appears to think the MHRA will take the full 80 days for Phase 1 as they tell the Court and the opposing legal team that the inspection process will take three months.
I’ll go through different scenarios assuming the full 80 day Phase 1.
Approval Scenarios:
Not an exhaustive list. Assuming validation on, or before, January 4, 2024.
March/April ’24 Approval (scenario 1): Only a Phase 1 is required taking 80 days. Assuming the 1-4-24 validation date, this brings us to March 24, 2024.
May/June ’24 Approval (scenario 2): A Phase 1 that takes the full 80 days. I’ll assume a clock off period and Phase 2 that take half the customary time (80+30+35). This brings us to May 28, 2024.
July/August ’24 Approval (scenario 3): A Phase 1 is required taking 80 days. A full clock off period is required taking 60 days. Phase 2 takes an additional 70 days (150 total clock on days). This brings us to August 1, 2024.
September/October ’24 Approval (scenario 4): Phase 1 80 days. Clock off 60 days. A request for an extension of 60 days for a total clock off of 120 days. Phase 2 70 days. This brings us to September 30, 2024.
Thoughts
I believe approval scenario 1 is very optimistic and not likely to happen. I believe approval scenario 2 is possible. I believe approval scenario 3 is the most likely. I believe approval scenario 4 is possible, or even a longer timeline if NWBO requests further extensions.
DCVax-L approval Q2 or Q3 of ’24.
All imo.
[1] https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
[2] https://gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
biosectinvestor
Member Level
Re: Inquirig post# 667534
Friday, January 26, 2024 3:53:15 PM
Post#
667537
of 667546
You don’t patent a trial. Dr. Liau would not be on NWBO’s SAB. NWBO is not a sponsor, but the drug used in that trial is DCVax-L.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
“A vaccine to treat glioblastoma
Glioblastoma is the most aggressive primary brain tumor in adults, with more than 10,000 new cases diagnosed in the United States each year. Standard treatment involves surgery, radiation, and chemotherapy; and the median overall survival rate is only 15 to 17 months from diagnosis.
A vaccine to treat glioblastoma called DCVax-L has been in development for several years. Linda Liau, MD, PhD, MBA, and a team of UCLA researchers were the first to investigate whether a patient’s own dendritic cells (a specialized type of immune cell) could be used to create a personalized treatment for the deadly cancer.
“We tested the method with a single patient in 1997, and then moved to a phase 1 safety trial in the early 2000s,” says Dr. Liau, professor and chair of Neurosurgery at UCLA.
A series of phase 2 early efficacy and optimization trials followed, and then an international, multi-site study led by Dr. Liau began in 2007.
The vaccine consists of two components: a patient’s dendritic cells, which are special types of immune cells, and proteins prepared from a patient’s tumor.
To create the vaccine, which is individualized for each patient, medical staff first perform a procedure called leukapheresis, in which a patient’s blood is drawn and their white blood cells are collected. Then, the patient’s tumor is removed and sent to a lab where researchers obtain proteins from the specimen, called tumor lysate. The white blood cells are cultured to differentiate into dendritic cells, and then combined with the tumor lysate to make the vaccine.
Dendritic cells are “antigen-presenting” cells, which means that they are able to process all kinds of foreign invaders in the body and alert the immune system’s T cells to mobilize a broad immune response against those invaders. Glioblastoma is a highly heterogenous disease, meaning there are many different types of cancer cells within a single tumor. Therefore, the dendritic cells — loaded with a patient’s own tumor lysate — allow a patient’s immune system to recognize a wide variety of tumor targets and spur the immune system to respond, according to Dr. Liau.
The phase 3 trial led by Dr. Liau involved 331 study participants at 80 sites around the world from August 2007 to November 2015. During the study, 232 people received standard care and DCVax-L at new diagnosis, while 64 out of 99 people received standard care and a placebo. (Patients in the placebo group received the DCVax-L at recurrence.)
The trial results, published in JAMA Oncology in November 2022, showed that newly diagnosed glioblastoma patients receiving the vaccine had an overall survival of 19.3 months on average, compared to 16.5 months on average among the contemporaneous, matched external control group.
“There is a significant subgroup of patients who lived more than five years, but the challenge is trying to determine which patients it may work for, and for which patients it doesn’t,” Dr. Liau says.
At UCLA, Dr. Liau and other researchers are now testing whether the vaccine would be more effective in combination with a PD-1 checkpoint inhibitor. Checkpoint inhibitors are a type of immunotherapy that work by blocking proteins that stop the immune system from attacking cancer cells. While the vaccine allows T-cells to get inside of the tumor, the checkpoint inhibitors may allow T-cells to be more functional and better attack the tumor cells.
“Because of the heterogeneity of glioblastoma, I don’t think there is going to be one drug or one treatment that is going to be effective for all patients. The future of glioblastoma treatments is going to be these combination approaches,” Dr. Liau says.”
Inquirig:LP brought this to the world:https://twitter.com/AllenTurner206/status/1625866069780070401.And you say,"LP is a disgrace to all women .".
Re: dstock07734 post# 667457
Friday, January 26, 2024 2:36:47 PM
Post#
667463
of 667499
LP is a disgrace to all women
🤔Speculative #DCVax-L Approval Timelines🤔$NWBO
— hoffmann6383 (@hoffmann6383) January 26, 2024
On December 20, 2023, Northwest Biotherapeutics, Inc. (NWBO) submitted their Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) requesting to be reviewed under the…
https://www.investorvillage.com/uploads/88540/files/Advent.pdf
abc1212
Breakthrough blood test can spot lethal brain tumours
A simple blood test could help diagnose patients with the deadliest form of brain cancer, researchers have found.
Trials by the Brain Tumour Research Centre of Excellence, part of Imperial College London, found they could identify traces of the disease in standard blood samples.
Experts say it could speed up diagnosis and treatment, while reducing the need for invasive and risky surgery used to diagnose most brain tumours. They said the 'liquid biopsy' would be particularly beneficial for patients with inaccessible brain tumours, meaning they could start treatment as soon as possible.
https://www.dailymail.co.uk/health/article-13007943/blood-test-spot-lethal-brain-tumours.html
Branster: "Possible Partnership deals before approval, Nature Article published, Court Case MTD denied and DCVax + Poly-ICLC (NCT01204684) Phase II Study Completion results" $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) January 26, 2024
Here is a Catalyst Link that may help you.https://t.co/Ch4qHU1Z6i
biosectinvestor
https://www.reddit.com/r/Superstonk/comments/19ffv1r/the_market_makers_kryptonite_civil_spoofing/
Branster: "Possible Partnership deals before approval, Nature Article published, Court Case MTD denied and DCVax + Poly-ICLC (NCT01204684) Phase II Study Completion results" $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) January 26, 2024
Here is a Catalyst Link that may help you.https://t.co/Ch4qHU1Z6i
biosectinvestor
branster
667161
Krisgo,
Possible Partnership deals before approval, Nature Article published, Court Case MTD denied and DCVax + Poly-ICLC (NCT01204684) Phase II Study Completion results to name a few
Here is a Catalyst Link that may help you.
https://www.reddit.com/r/NWBO/comments/16ipzhq/nwbo_catalyst_list_update_202324/
biosectinvestor
Member Level
Re: Inquirig post# 667137
Thursday, January 25, 2024 7:51:03 PM
Post#
667143
of 667265
Nonsense. You are opining on something for which clearly you do not have the information. It is the reverse. But right now, pre-approval, I would bet since Advent is the local agent, they are booking revenue and netting it against expenses. So you can’t really make your claim. Advent is local, they put the drug together and it is not licensed for marketing to NWBO. But the revenue belongs to NWBO ultimately and on approval the same will be the case.
After set costs and per product costs which are probably in the 20-30,000 range, the full amount belongs to NWBO. There is no “royalty” arrangement with Advent. Advent is a contractor ONLY. They have no IP here. They do not own anything. So just that use of language alone suggests you’re posting way beyond your expertise. Also, I believe with inflation, in the long-run, the total cost will be in the 220,000 range. So more likely the revenue per patient may be anywhere from 150,000 to just shy of 200,000 per patient. But it depends probably on how long patients live and also how many of different types of cancer.
Right now we are seeing patients in the one arm, with one form of brain cancer, when adding poly-iclc shots, living beyond 9 and 10 years without recurrence, so that makes the cost even at 220,000 very low comparatively. In fact, based on those results, they could get approval, even in the UK, for premium pricing, but I suspect LP might be too idealistic to do that though I think it makes discounting for patients who are not covered by insurance, more sustainable and they can then have a range of pricing.
But you’re just basically not understanding the situation, taking out of date details and false information and making crap up.
As for the cost, while the up front costs are set, it is extremely competitive with other immunotherapies given extension of survival and cost per month. The main cost is up front, and is not what you say. Further, they appear to be working on a per injection follow-on after the up-front cost but I am not sure if that is the plan post approval. But basically you’re talking approximately 3 years of vaccine that can be made up front.
Further, they have automation that will come online in the not too distant future and the factory operations and management belongs to NWBO, so they will determine the mode of operation, who manages production, etc. They can also terminate any contract with any CDMO and pull it all in-house, of course with a transition period, which is built into their contract.
You clearly have no idea what you're talking about.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
biosectinvestor
Member Level
Re: Inquirig post# 667137
Thursday, January 25, 2024 7:51:03 PM
Post#
667143
of 667265
Nonsense. You are opining on something for which clearly you do not have the information. It is the reverse. But right now, pre-approval, I would bet since Advent is the local agent, they are booking revenue and netting it against expenses. So you can’t really make your claim. Advent is local, they put the drug together and it is not licensed for marketing to NWBO. But the revenue belongs to NWBO ultimately and on approval the same will be the case.
After set costs and per product costs which are probably in the 20-30,000 range, the full amount belongs to NWBO. There is no “royalty” arrangement with Advent. Advent is a contractor ONLY. They have no IP here. They do not own anything. So just that use of language alone suggests you’re posting way beyond your expertise. Also, I believe with inflation, in the long-run, the total cost will be in the 220,000 range. So more likely the revenue per patient may be anywhere from 150,000 to just shy of 200,000 per patient. But it depends probably on how long patients live and also how many of different types of cancer.
Right now we are seeing patients in the one arm, with one form of brain cancer, when adding poly-iclc shots, living beyond 9 and 10 years without recurrence, so that makes the cost even at 220,000 very low comparatively. In fact, based on those results, they could get approval, even in the UK, for premium pricing, but I suspect LP might be too idealistic to do that though I think it makes discounting for patients who are not covered by insurance, more sustainable and they can then have a range of pricing.
But you’re just basically not understanding the situation, taking out of date details and false information and making crap up.
As for the cost, while the up front costs are set, it is extremely competitive with other immunotherapies given extension of survival and cost per month. The main cost is up front, and is not what you say. Further, they appear to be working on a per injection follow-on after the up-front cost but I am not sure if that is the plan post approval. But basically you’re talking approximately 3 years of vaccine that can be made up front.
Further, they have automation that will come online in the not too distant future and the factory operations and management belongs to NWBO, so they will determine the mode of operation, who manages production, etc. They can also terminate any contract with any CDMO and pull it all in-house, of course with a transition period, which is built into their contract.
You clearly have no idea what you're talking about.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
CLIENT PARTNERSHIP PROFILE
Advent aim to provide GMP production facilities and systems which will be adaptable to our clients needs. This gives the capacity for clients to scale-up and improve their ATMP manufacturing capabilities according to their unique product and patient requirements.
Our clients consist of International Pharma, Emerging Biotechnology/Gene and cell therapy companies.
Inquirig
Re: None
Friday, January 26, 2024 8:17:15 AM
Post#
667248
of 667259
https://www.adventbio.uk/
Services & Facilities
The UK cell and gene therapy industry is expanding at a rapid rate. In the last 5 years, cleanroom space increased annually to a current total of 7819 sq m and the UK initiated 112 new ATMP clinical trials - the highest number for all European countries. This has resulted in strong demand for GMP manufacturing services, expertise in commercialisation and scale up of manufacture.
Inquirig:Has the Advent website been updated recently?
Re: None
Friday, January 26, 2024 8:17:15 AM
Post#
667248
of 667257
https://www.adventbio.uk/
Services & Facilities
The UK cell and gene therapy industry is expanding at a rapid rate. In the last 5 years, cleanroom space increased annually to a current total of 7819 sq m and the UK initiated 112 new ATMP clinical trials - the highest number for all European countries. This has resulted in strong demand for GMP manufacturing services, expertise in commercialisation and scale up of manufacture.
biosectinvestor
Member Level
Re: flipper44 post# 667180
Friday, January 26, 2024 3:52:40 AM
Post#
667216
of 667255
Toucan is not profiting and I doubt Advent is either. There is no rule against absorbing expense through the contractor and in fact given the contract, given the program and generally what I see of commercial contracts in not entirely dissimilar circumstances, what I said actually seems likely.
They cannot market. They cannot promote. And it is likely they cannot charge directly give the Specials program. Advent likely has to be the agent and they likely owe Advent for scaling up at this point. So if revenues for the time being are being netted out as paid invoices, not a huge deal.
I do not expect them to clarify because that might create opportunities for shorts to claim they are engaged in a commercial business, which is literally not the case under the specials program. Generally these early access programs only allow companies to recoup costs anyway, so the approach I explained also makes sense from that perspective given that they had to scale up and have a commercial operation long before they could market and even still, you don’t see a lot of going to the market to raise 50 or 100 million to do it.
I think they are likely operating about as efficiently as one could expect. As for the claims by Les, probably better left unsaid, but on the other hand people demand updates and that is one way to get information out without doing PR’s or other things that likely would not be perceived well by a regulator if only specifically on the point of “revenues” for the Specials program. I think rather it seems like their cash burn has not substantially increased, as if they are a commercial operation even though they are fully licensed for commercial production, and that is likely not an accident.
I think it’s just obvious from the details and even I find ChatGPT mirroring what I said. It’s structured to manage the specials program and the risks that come with gearing up to provide DCVax-L pursuant to it, the additional costs and also dealing with a jurisdiction in which NWBO is not licensed to market and the specials program is extremely narrow in how it explains its exception. Basically it’s like a compound pharmacy providing that drug in that jurisdiction and I think that is the only real exception for providing it. Advent is locally incorporated and licensed to perform the relevant function and take the funds, but it also happens to have built and to manage the commercially licensed facility for a company that otherwise had no other cash flow and no licensed products in that or any other jurisdiction. So the costs for that facility would typically be a huge cash burn. Yet we’re not seeing a lot of signs of that. I think it is reasonable to assume that Advent can collect on the funds due with that cash flow, leaving NWBO without the need to do a massive cash raise to support its commercially licensed factory.
I don’t think the MHRA wants them claiming revenues that can affect their market cap either, that is not far from “marketing”, claiming a sales number, previous to licensing. So I would expect that all is very complex from a regulatory perspective.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
biosectinvestor
Member Level
Re: Inquirig post# 667155
Thursday, January 25, 2024 9:34:29 PM
Post#
667174
of 667197
Here is your ChatGPT analysis of the situation, which is wholly consistent with my own interpretation. It exactly fits the facts. There is nothing about royalties and the $150,000 is for the first year of doses. Note the contract is dated 2021 at the bottom. The description fits the requirements of the Specials Program exemption that allows patients to have access to an unlicensed drug early, before it is licensed for marketing. It can basically be assembled or manufactured locally for the Specials Program, but not marketed.
NWBO is not a UK company and again, they can’t “market” the drug.
“The UK Specials program allows the manufacture and supply of unlicensed medicines in response to a specific request by a doctor for use by individual patients on a named-patient basis. This program is particularly relevant for drugs that are not yet licensed for marketing in the UK, like NWBO's DCVax-L. Here's how this arrangement would typically work within the framework of the UK Specials program:
1. **Manufacturing by a UK-based CDMO**: Advent, being a Contract Development and Manufacturing Organization (CDMO) in the UK, is likely authorized under the Specials program to manufacture DCVax-L. Even though NWBO, a U.S.-based company, owns the technology and formulation, the actual production is handled by Advent at the Sawston facility.
2. **Named-Patient Basis**: Under the Specials program, Advent can supply DCVax-L directly to individual patients whose doctors have prescribed it, specifically for treating Glioblastoma or other tumors. This is done on a named-patient basis, meaning the drug is provided only to specific patients as identified by their physicians, not broadly marketed or available to the general public.
3. **Compliance with Regulatory Standards**: The manufacturing and supply of the drug must comply with the regulatory standards set by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This includes quality assurance, record-keeping, and reporting adverse events.
4. **Role of NWBO**: NWBO's role in this setup is likely focused on the intellectual property, formulation, and clinical data supporting the use of DCVax-L. While they can't market the drug in the UK due to its unlicensed status, they can facilitate its production through their agreement with Advent.
5. **Limited Marketing and Distribution**: The drug cannot be marketed or distributed broadly in the UK. It can only be provided to specific patients for whom it has been prescribed, and this is typically done in the context of ongoing clinical trials or compassionate use.
This structure allows NWBO to leverage Advent's manufacturing capabilities within the UK, complying with local regulations and facilitating access to their drug for specific patients in need, despite it not being formally licensed for marketing in the UK.”
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
Upon discovery, will revelation of the Defendats' clients lead to them being added to the Plaintif's liability charges ? I.E., do spoofed trades in Citadel Google pension fund account make Google culpable also ?
https://reddit.com/r/Superstonk/comments/19ffv1r/the_market_makers_kryptonite_civil_spoofing/…
https://t.co/nqJTXxH4Cg https://t.co/AUb1v42gcI$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) January 25, 2024
Reddit moderators took took this @hoffmann6383 report down twice earlier today . What is it about discovery that scares the Defendants so much ; DC VAX L becoming a cure for cancer ?
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
https://www.researchsquare.com/article/rs-3287211/v1
https://www.reddit.com/r/Superstonk/comments/19ffv1r/the_market_makers_kryptonite_civil_spoofing/
https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.95.0.pdf
$nwbo @alphavestcap
CaptainObvious
Re: CaptainObvious post# 666583
Thursday, January 25, 2024 9:17:54 AM
Post#
666879
of 666906
01/25/24 - 1,182,971,840
01/24/24 - 1,182,454,590
01/23/24 - 1,182,433,108
01/19/24 - 1,181,833,108
01/09/24 - 1,181,176,418
01/04/24 - 1,175,459,031
01/03/24 - 1,173,563,502
2023:
12/23/23 - 1,172,382,472
01/06/23 - 1,061,044,165
2023 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173492032
2022:
12/21/22 - 1,058,132,006
01/22/22 - 949,180,606
2022 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170751056;
2021:
12/31/21 - 947,621,531
01/12/21 - 822,825,147
2020:
12/31/20 - 822,716,397
01/27/20 - 625,187,160
2020-2021 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167328119;
Shares outstanding from
https://www.otcmarkets.com/stock/NWBO/quote
Bullish
BULLISH
Re: FeMike post# 666876
Thursday, January 25, 2024 9:16:30 AM
Post#
666878
of 666907
She said:
….as soon as we've got the application for approval cemented, we're very eager to proceed with these combos.
The combos she’s referring to are ones they previously delayed because the financial terms weren’t sufficient.
Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.
Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest than its shareholders.
We have actually -- we actually walked away from a combo trial that we could have proceeded with before. The terms were quite unfavorable with us supposed to supply everything and receive very little. So we're not going to do that. So anyway, that's our perspective on combo trials
Member Level
Re: Zadie420 post# 666869
Thursday, January 25, 2024 9:05:02 AM
Post#
666871
of 666907
My two cents. Linda was basically alerting us that whomever they’ve been in active discussions with, is awaiting the cement to cure on the maa in order to employ whatever terms they have had over a year (now) to work on.
I thought, and so did multiple AI, that cement meant acceptance/validation, but it’s starting to look like Doc is right that it might mean the first 80 days or nearby conclusion of CHM meeting.
There is always a possibility, it is moving more swiftly* (or slowly).
The MHRA is still trying to get back to me on whether or not they’re implementing/developing a faster approval process for high-impact therapies. Previously introduced as a priority in March 2023.
Re: None
Thursday, January 25, 2024 8:04:00 AM
Post#
666838
of 666908
LAVA Therapeutics Announces Collaboration with Merck & Co., Inc., Rahway, NJ, USA to Evaluate LAVA-1207 in Combination with KEYTRUDA®
Collaboration will support the initiation of a combination arm in the ongoing Phase 1/2a trial in patients with mCRPC
Enrollment will continue in the monotherapy and IL-2 combination arms of the study
UTRECHT, The Netherlands and PHILADELPHIA, Jan. 25, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (Nasdaq: LVTX), today announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207, a Gammabody® designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).
Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207 (NCT05369000), with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study.
“We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®,” said Stephen Hurly, President and Chief Executive Officer, LAVA. “To date, LAVA-1207 has demonstrated a favorable safety profile and shown preliminary signs of anti-tumor activity. Prostate cancer has presented challenges for immune checkpoint therapies in the past – we are hopeful the combination of our products may deliver important clinical outcomes.”
“The immunosuppressive tumor microenvironment in most mCRPC patients has resulted in overall low antitumor activity for immune checkpoint inhibitors,” commented Hans van der Vliet, M.D., Ph.D., Chief Scientific Officer, LAVA. “Increased numbers of V?9Vd2 T cells have been shown to be related to improved outcomes in prostate cancer patients. With LAVA-1207, we aim to promote the antitumor activity of V?9Vd2 T cells present in these tumors and drive more of these cells into the tumors, where their activation may result in increased PD-1 expression. By utilizing LAVA-1207 and pembrolizumab, our goal is to evaluate the potential activation of V?9Vd2 T cells to directly attack prostate cancer cells and trigger a broader antitumor immune response that may also benefit from inhibition of PD-1 through pembrolizumab.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA.
About LAVA-1207
LAVA-1207 is a proprietary Gammabody® that conditionally activates V?9Vd2 (Vgamma9 Vdelta2) T cells, upon crosslinking to prostate-specific membrane antigen (PSMA), to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC).
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering V?9Vd2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens. A Phase 1/2a dose escalation study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States (NCT05369000). The Company is collaborating with Seagen for the clinical development of SGN-EGFRd2 (LAVA-1223) and Merck & Co., Inc., Rahway, NJ, USA for the clinical development of LAVA-1207. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, and YouTube.
Re: Chiugray post# 666795
Wednesday, January 24, 2024 10:58:01 PM
Post#
666815
of 666908
Thanks Chiugray, you are correct that an approved label by the MHRA for DCVax-L for all malignant gliomas would significantly increase the addressable market size for DCVax-L in the UK.
The table that was put together by the American Society of Gene & Cell Therapy (ASGCT), is not the only evidence that gives support to this possibility.
When NWBio received the EAMS and PIM designation from the MHRA back in 2014, it included all malignant brain tumors:
The PIM designation for DCVax-L covers all malignant gliomas, which would include both Glioblastoma multiforme (the most severe grade) as well as less malignant grades, and would include both newly diagnosed and recurrent gliomas.
https://nwbio.com/nw-bios-cancer-vaccine-is-the-first-drug-to-be-designated-by-uk-authorities-as-a-promising-innovative-medicine-pim/
According to the press release link, the PIM certification never expires. I believe the key, is whether or not the brain tumor is considered to be malignant. That would apply to all Grade 4, and Grade 3 gliomas.
In addition, take a look at the MHRA approved Paediatric Investigation Plan (PIP) for DCVax-L. As we all know, the PIP label will also closely mirror the approved label for adults treated with DCVax-L.
The conditions that are being treated in the PIP are not just nGBM and rGBM (Grade IV gliomas), but all high grade gliomas, which would also include Grade III gliomas:
https://cms.mhra.gov.uk/system/files/2022-09/mhra-100409-pip01-21.pdf
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
TIME IS RUNNING OUT. THE CLOCK IS TICKING!!!
It appears that Dr. Linda Liau and her team at UCLA have successfully used CRISPR technology invitro to change unmethylated solid tumor cancers into methylated ones . In future clinical trials , it could be proved that a higher percentage of solid tumor cancer patients get cured:
"dCas9/CRISPR is a viable method of epigenetic editing, using the DNMT3A catalytic domain. This study provides initial proof-of-principle for CRISPR technology applications in malignant glioma, laying groundwork for subsequent translational studies, with implications for future epigenetic editing-based clinical applications."
https://link.springer.com/article/10.1007/s11060-023-04531-z
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173680608";
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173681773
ATLnsider commenting on (https://link.springer.com/article/10.1007/s11060-023-04531-z) :" I agree abc1212, Dr. Liau and her team at UCLA are quietly and deliberately finding a cure for 100% of GBM patients.
Using DCVax has moved the cure rate from around 5% to around 13%. Using DCVax along with poly-ICLC has moved the cure rate to about 50%.
Adding combination treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors may move the cure rate to 65%+.
Now, using DCVax along with poly-ICLC, along with other combination treatments like PD-1 inhibitors, PDL-1 inhibitors, CSF-1R inhibitors, and CRISPR technology to convert unmethylated patients into methylated patients, will get Dr. Liau closer to her goal of helping 100% of cancer patients."
https://giving.lifespan.org/RIH/Grant-Brain-Cancer (and Dr.Toms getting into epigenetic editing)
https://link.springer.com/article/10.1007/s11060-023-04531-z
https://d1io3yog0oux5.cloudfront.net/_32740ef31bf889781b5c815a65789708/clearpointneuro/db/77/2871/pdf/CLPT+Investor+Deck_JPM+2024_FINAL+JPM.pdf
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
Impressive LCM strategy before initial approval! #dcvax $nwbo
— Allen Turner (@AllenTurner206) February 15, 2023
DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.
DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo
https://giving.lifespan.org/RIH/Grant-Brain-Cancer
https://link.springer.com/article/10.1007/s11060-023-04531-z
https://d1io3yog0oux5.cloudfront.net/_32740ef31bf889781b5c815a65789708/clearpointneuro/db/77/2871/pdf/CLPT+Investor+Deck_JPM+2024_FINAL+JPM.pdf
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
Impressive LCM strategy before initial approval! #dcvax $nwbo
— Allen Turner (@AllenTurner206) February 15, 2023
DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.
DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo
https://t.co/OcJHuN3F1w $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) January 24, 2024
"dCas9/CRISPR =epigenetic editing, using the DNMT3A .. This study .. initial proof-of-principle for CRISPR technology applications in malignant glioma; subsequent translational studies;future epigenetic editing clinical applications.