NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

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The short have been preparing for the next short covering before the inevitable after its 1st round of covering on 31 Otc.
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2nd short covering today? If I were a short, I would buy today, or be forced to cover on later days with much higher price.

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10Q out. Nothing new except some hint on lawsuits against a 3rd party who acted on behalf of manipulatory short selling. It seems Linda and Les would live 1000 years so time is not a problem for them. Slow process, but I cannot do anything but hold, and from time to time add some here and there, for the final validation of DCVax platform.

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It seems DCVax-L is given a potential commercial brand name by regulatory agencies -- murcidencel.

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Abstract of the presentation which will be presented by Dr. Liau along with other 49 authors on 20 Nov is now published in NEURO - Oncology November 2022 Issue. Note don't confuse it with the peer-reviewed journal publication we all have been anticipating.

academic.oup.com

CTIM-27. AUTOLOGOUS TUMOR LYSATE-LOADED DENDRITIC CELL VACCINATION IMPROVES SURVIVAL IN PATIENTS WITH NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA: SURVIVAL RESULTS FROM A PHASE 3 TRIAL

AbstractBACKGROUND. Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years. We evaluated in a phase 3 trial w
academic.oup.com academic.oup.com

CTIM-27. AUTOLOGOUS TUMOR LYSATE-LOADED DENDRITIC
CELL VACCINATION IMPROVES SURVIVAL IN PATIENTS WITH
NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA:
SURVIVAL RESULTS FROM A PHASE 3 TRIAL
Linda M. Liau1, Keyoumars Ashkan2, Steven Brem3,
Jian Campian4, John Trusheim5, Fabio Iwamoto6, David Tran7,
George Anstass8, Charles Cobbs9, Jason Heth10, Michael Salacz11

Stacy D'Andre12, Robert Aiken13, Yaron Moshel13, JooYeon Nam14,
Clement Pillainayagam15, Stephanie Wagner16, Kevin Walter17,
Rekha Chaudary18, Samuel Goldlust19, Ian Lee20, Daniela Bota21,
Heinrich Elinzano22, Jai Grewal23, Kevin Lillehei24, Tom Mikkelsen25,
Tobias Walbert20, Steve Abram26, Andrew Brenner27, Matthew Ewend28,
Simon Khagi29, Darren Lovick30, Jana Portnow31, Lyndon Kim32,
William Loudon33, Nina Martinez34, Reid Thompson35, David Avigan36,
Karen Fink37, Francois Geoffroy38, Pierre Giglio39, Oleg Gligich40,
Dietmar Krex41, Scott M Lindhorst42, Jose Lutzky43, Hans-Joerg Meisel44,
Minou Nadji-Ohl45, Lhagva Sanchin44, Andrew Sloan46, and
Marnix Bosch47; 1University of California, Los Angeles, Los Angeles,
USA, 2King's College Hospital, London, United Kingdom, 3University
of Pennsylvania, Philadelphia, PA, USA, 4Mayo Clinic, Department
of Oncology, Rochester, MN, USA, 5Abbott Northwestern Hospital,
Minneapolis, USA, 6Division of Neuro-Oncology, New York-Presbyterian/
Columbia University Medical Center, New York, NY, USA, 7University of
Florida, Gainesville, FL, USA, 8Washington University, St. Louis, MO, USA,
9Swedish Hospital, Seattle, WA, USA, 10University of Michigan, Ann Arbor,
MI, USA, 11Rutgers University, New Brunswick, NJ, USA, 12Mayo Clinic,
Rochester, MN, USA, 13Atlantic Healthcare, Summit, NJ, USA, 14Rush
Medical College, Chicao, IL, USA, 15The Ohio State University, Columbus,
OH, USA, 16Columbus Regional Health, Columbus, IN, USA, 17University
of Rochester, Rochester, NY, USA, 18University of Cincinnati, Cincinnati,
OH, USA, 19Hackensack University, Hackensack, NJ, USA, 20Henry Ford
Health, Detroit, MI, USA, 21University of California Irvine, Irvine, CA,
USA, 22Rhode Island Hospital, Providence, RI, USA, 23Mount Sinai South
Nassau Hospital, Oceanside, NY, Oceanside, NY, USA, 24University
of Colorado, Denver, CO, USA, 25Henry Ford Health System, Detroit,
MI, USA, 26St. Thomas Hospital, Nashville, TN, USA, 27UT Health San
Antonio, San Antonio, TX, USA, 28University of North Carolina, Durham,
NC, USA, 29Dartmouth University, Hanover, NH, USA, 30Advent Health,
Kansas City, KS, USA, 31City of Hope, Duarte, CA, USA, 32Mount Sinai
Hospital, New York, NY, USA, 33St. Joseph's Hospital, Orange, CA, USA,
34Jefferson University, Philadelphia, PA, USA, 35Vanderbilt University,
Nashville, TN, USA, 36Beth Israel Deaconess Medical Center, Cambridge,
MA, USA, 37Baylor University Medical Center, Dallas, TX, USA, 38Illinois
Cancer Care, Peoria, IL, USA, 39Ohio State University Comprehensive
Cancer Center, Columbus, OH, USA, 40Mount Sinai Medical Center, Miami
Beach, FL, USA, 41Department of Neurosurgery, University of Dresden,
Dresden, Germany, 42Medical University of South Carolina, Charleston,
SC, USA, 43University of Miami, Miami, FL, USA, 44Bergmannstrost, Halle,
Germany, 45Klinikum der Landeshauptstadt Stuttgart, Stuttgart, Germany,
46Department of Pathology and Department of Neurosurgery, Case
Western Reserve University and University Hospitals Cleveland Medical
Center; Seidman Cancer Center and Case Comprehensive Cancer Center,
Cleveland, USA, 47Northwest Biotherapeutics, Inc, Bethesda, MD, USA
BACKGROUND: Standard of care (SOC) and patient survival in glio-
blastoma have changed little in the past 17 years. We evaluated in a phase 3
trial whether adding an autologous tumor lysate-loaded dendritic cell vaccine
(murcidencel) to SOC extends survival. Patients and METHODS: Newly
diagnosed glioblastoma patients were randomized 2:1 to either murcidencel
or placebo. Under a crossover design, all patients could receive murcidencel
following tumor recurrence. All parties remained blinded regarding treat-
ments before recurrence. Patients thus received murcidencel at new diag-
nosis (nGBM) or at recurrence (rGBM) following crossover from placebo.
The primary and secondary endpoints compare overall survival (OS) with
contemporaneous, matched external controls. Four sets of analyses were
conducted to ensure rigorous matching of the controls, reduce biases, and
confirm the robustness of the results. RESULTS: 331 patients were enrolled.
With the crossover, 89% received murcidencel. Median OS (mOS) for nGBM
patients (n = 232) was 19.3 months from randomization (22.4 months from
surgery) with murcidencel vs. 16.5 months from randomization in the con-
trols (HR = 0.80, p = 0.002). Survival at 48 months from randomization
was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%. For rGBM
(n = 64), mOS was 13.2 months from relapse vs. 7.8 months in the controls
(HR = 0.58, p < 0.001). Survival at 24 months post-recurrence was 20.7%
vs. 9.6%, and at 30 months post-recurrence was 11.1% vs 5.1%. In nGBM
patients with methylated MGMT (n = 90), mOS was 30.2 months from
randomization (33 months from surgery) with murcidencel vs. 21.3 months
from randomization in the controls (HR = 0.74, p = 0.027). The treatment
was well tolerated, with only 5 serious adverse events deemed at least pos-
sibly related to the vaccine. CONCLUSION: Clinically meaningful and
statistically significant survival extension was seen in both nGBM and
rGBM patients treated with murcidencel and SOC compared with contem-
poraneous, matched external controls who received SOC alone.
 
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For those trading this stock (not me of course), be aware of shitting yet practical concept of sell the news. For long-term investors for big prize, day to day ups and downs is just entertaining!

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"The hope is that personalised immunotherapy, which stimulates the patient’s immune system to fight their tumour, will bring better news for these patients, he says.

In a trial with a type of immunotherapy called DCVax-L at more than 90 hospitals across the world, including the UK, immune cells and tumour cells from a patient’s blood were exposed to each other in a lab to ‘teach’ the immune cells to recognise proteins associated with the patient’s cancer. The immune cells were then injected back into the patient. Preliminary results suggested DCVax-L helps extend survival for GBM patients."

www.dailymail.co.uk

Paralysed by brain cancer: Jamie, 61, is pleading for extra funding

In May, Jamie Fairweather was a super-fit 61-year-old cycling on holiday in Majorca. By mid-September he could no longer feed himself or use the bathroom independently.
www.dailymail.co.uk www.dailymail.co.uk
 

Northwest Biotherapeutics’ Day Has Come at Last | Expert Financial Analysis and Reporting | Smith on Stocks

I’m Back Earlier this year I decided to end subscriptions to SmithOnStocks.com. Researching and writing articles on biotechnology companies required a significant amount of time and effort that detracted from other things that I wanted to do. I am very curious by nature and get genuinely excited...
smithonstocks.com smithonstocks.com

Expert Financial Analysis and Reporting​




Northwest Biotherapeutics’ Day Has Come at Last​


Posted by Larry Smith on Nov 16, 2022 • (0)

I’m Back
Earlier this year I decided to end subscriptions to SmithOnStocks.com. Researching and writing articles on biotechnology companies required a significant amount of time and effort that detracted from other things that I wanted to do. I am very curious by nature and get genuinely excited when learning new things. My interests include biology, of course, which drives the biotechnology and pharma companies that I focused on in my blog, but it doesn’t end there. I now spend anywhere from four to eight hours a day studying all manner of interesting subjects such as anthropology, history, paleontology, cosmology, relativity, quantum mechanics, and on and on. The Internet gives me access to thoughts of many brilliant people and it is just so stimulating to learn from them. This is exciting and as I approach my eightieth decade on my life, I believe this is one of the most fulfilling periods
I know that there is a general feeling of doom and malaise given all the things that we humans are now going through- the pandemic and resultant problems, the Ukraine war, apocalyptic concerns about the global warming that is occurring, the inflation brought on by unbelievably wrong monetary policy and fiscal over stimulation which poured money on the economy like rain from a hurricane, life altering crime in major cities, open southern border, fentanyl deaths, and more. It is hard not to feel despair at times. However, my studies have led me to believe that this is an incredible age of innovation and discovery. I think that knowledge is expanding exponentially. I think that in just a few years (say ten) that we will live in a world transformed and that we cannot imagine right now. This has the potential to solve the many intractable problems that we face and lead to a golden age. If so, there should be incredible investment opportunities over the next decade as innovation drives economic growth and stock prices.
I have cut back on writing, but not on research. I still keenly follow developments in biotechnology and will from time to time write articles that are free to anyone who may be interested. Those of you have followed my work know that there is no company on which I have done more work than Northwest Biotherapeutics. The number of articles published on my website attests to this. See this link. I believe we are now on the cusp of a string of major developments which will establish NWBO as a dynamic biotechnology company. I plan to address these on my blog.

My Bullish Stance on Muricidencel (formerly DCVax-L) Has Been Drowned Out by the Wolfpack
It has been my position that murcidencel (formerly known as DCVax-L) represents a major breakthrough and that it will become part of standard of care (SOC) in newly diagnosed glioblastoma multiforme (ndGBM); this would be the first improvement in SOC in 17 years. I also think that when added to the cancer drug temozolomide and radiation, it will become part of the first approved therapy for recurrent GBM (rGBM).
In terms of writing in depth reports I have been the lone positive voice on Wall Street supporting NWBO for these last several years. This small company should have been a Wall Street darling because if my analysis is correct, murcidencel ranks as one of the most commercially and medically important drugs ever developed by the biopharma industry. Moreover, the technology used to develop it could be applicable to all solid tumors giving NWBO an extremely interesting pipeline in oncology.
As striking as the drug development of murcidencel has been, even more striking is that the company has been ignored by institutional investors and sells for less than a dollar per share. Indeed, several times in the last few years, it has been under financial distress that have raised concerns about viability. What gives? I have frequently written about what I believe is a coordinated and criminal attack by hedge funds and market makers (I call these players the wolfpack) to manipulate the stock price. Using illegal naked shorting, algorithmic trading using spoofing and broad based fomenting on social media, they have been trying to bankrupt the company. I hypothesize that these bad acters may have 1 billion or more naked shorts outstanding. This would explain why they have been trying desperately to bankrupt the company as this is the only way to avoid a massive short squeeze.
I have been a tiny positive voice in the wilderness as wolfpack fomenters have repeatedly alleged that murcidencel failed the phase 3 trial and that CEO Linda Powers has been running a Ponzi scheme. This lying has been used as cover for massive illegal naked shorting that has been employed every time that NWBO makes a positive announcement. As Joseph Goebbels said “ A lie repeated once if just a lie, but a lie repeated a thousand times becomes the truth.” The aim of the wolfpack has been to make good news appear to be bad news. Nowhere is this more exemplified than on May 10 when unbelievably strong results were reported for the phase 3 trial of murcidencel at the New York Academy of Sciences only to see the stock plunge from a prior day closing price of $1.80 to an intraday low of $0.38. Some 77 million shares were traded on May 10 which compares to 1 million on a normal day. This was an awesome display of what spoofing algorithms can do. This is, of course, illegal.
I Now Feel Vindicated
Against all odds, CEO Linda Powers was able to successfully complete the phase 3 trial. With this I believe NWBO now has validation on the efficacy of murcidencel to break the back of the wolfpack attack through presenting overwhelming efficacy of murcidencel to the medical community and gaining their support. I point to three things that demonstrate that opinion leaders of the medical community validate my positive view on murcidencel.
A peer reviewed presentation on May 10th at the New York Academy of Sciences showed the outstanding results of murcidencel in ndGBM and rGBM for the first time. See this link for details. Alarmingly, the wolfpack was still able to destroy the stock price by falsely claiming that the trial failed and launching a massive shorting attack. In my opinion, the stock should have more than doubled on this news.
The next important point of validation for murcidencel will be a presentation by Dr. Linda Liau on November 20 at the Society for Neuro-Oncology Conference. She is a widely respected neuro surgeon, co-discoverer of murcidencel and lead investigator in the US on the phase 3 trial. As shown in the abstract, the conclusion of her talk is “Clinically meaningful and statistically significant survival extension was seen in both nGBM and rGBM patients treated with murcidencel and SOC compared with contemporaneous, matched external controls who received SOC alone.” This is the premier conference for physicians who treat brain tumors. The peer review of Dr. Liau’s talk and her oral presentation at the prestigious plenary session is a very powerful endorsement by key opinion leaders of the success of the phase 3 trial of murcidencel.
I am now awaiting publication of a peer reviewed article on the phase 3 trial in a leading medical journal such as the New England Journal of Medicine, Journal of the American Medical Association, Lancet, Journal of Clinical Oncology (published by ASCO), or the European Journal of Clinical and Medical Oncology. I am uncertain as to when this might occur, but it could be imminent. This could and should be the catalyst along with the past NYAS presentation and pending Society for Neuro-Oncology presentation by Dr. Liau that brings investors to realize that the criminal wolfpack disinformation campaign is based on a pack of lies.
The enthusiasm of the medical community is soon likely to be shared by investors.
Taking on the Wolfpack
The latest 10 Q has a new line that states "The Company is currently considering possibilities for legal actions against third parties who have attacked the Company." This implies that NWBO may be launching a lawsuit against the wolfpack. I am uncertain as to when this might occur, but it could be imminent. I would be excited to see this. We might see some wolfpackers doing a perp walk
 
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