Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is running northbound after the biotech reported that the Company, along with its partner Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly reported that a MIA license has been approved and issued by the MHRA for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K. This license is the culmination of more than 3 years’ work; now cell therapy products manufactured in the Sawston facility may be exported globally. This represents a major milestone for NW Bio and is an essential step towards submission of its application for regulatory approval of the Company’s lead product, DCVax®-L. This gives NW Bio the green light to move forward with applying for approval of DCVAX by the EMA which is believed the best way for eventual approval in the US.
NWBO is among the topmost traded stocks on the bulletin boards with an enormous following that regularly trades millions and sometimes 10s of millions in dollar volume per day. NW Bio recently reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive and deadly type of brain cancer representing a potential market already worth $2 billion. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma have failed with both median survival and the “long tail” of extended survival significantly increased in both newly diagnosed and recurrent glioblastoma brain cancer patients. NW Bio has also commenced a major lawsuit accusing Citadel Securities, Susquehanna and “other Wall Street firms of driving down its stock price through a series of illicit trading tactics such as repeatedly engaging in ‘spoofing,’ where traders place orders with an intent to fool other investors about a stock’s demand and manipulate the price. The lawsuit also includes Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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Northwest Biotherapeutics Inc
(OTCMKTS: NWBO) is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. NW Bio has developed a valuable Intellectual Property portfolio that consisted of 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families as of January 1, 2022. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products.
NW Bio’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). This Phase III trial was completed, and the results were presented in scientific meetings and published in JAMA Oncology. NWBO has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania. NW Bio believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
DCVax-L is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses and is “off the shelf” throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment. DCVax-L is also very simple for the physician and patient: just an intradermal injection in the upper arm, 6 times over the course of year 1, and then twice a year for maintenance thereafter.
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%. With DCVax®-L, which is successful where over 400 clinical trials for glioblastoma having failed, we see more than double the survival rates as with existing standard of care particularly in the “long tail” of the survival curve. It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile. The global glioblastoma multiforme treatment market size was valued at USD 2.14 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.8% from 2021 to 2028.
It is truly exciting that $NWBO will be able to manufacture #DCVax-L for solid tumor cancer patients around the world, on a compassionate use basis, before the MAAs & BLAs are commercially approved in US, UK, Canada, Germany & rest of the EU: https://t.co/UrEuDY7FuT pic.twitter.com/qMeZK1j82s
— ATLnsider (@ATLnsider) March 21, 2023
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$NWBO Persistence pays. Note; NWBO can now manufacture AND ship WORLDWIDE! https://t.co/Yu4B8U5jaB
— Gregory Zivic, MD (@metacollectiveG) March 20, 2023
Over the past two years NW Bio has been busy building out its Sawston, UK facility, which was designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. The Sawston facility contains a total of 88,345 square feet on two floors and initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually.
With the implementation of the Flaskworks system, NW Bio was able to simplify and streamline many phases of the buildout. The Company acquired Flaskworks, LLC, a company that has developed a system to close and automate the manufacturing of cell therapy products such as DCVax® with Flaskworks becoming a wholly owned subsidiary of NWBO. Flaskworks was previously owned by its technical founders and Corning Inc. The technical team from Flaskworks joined NW Bio as part of the Acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.
On March 20 NWBO announced that the Company along with its manufacturing partner Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly reported that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K.
This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the companies’ knowledge, there are only two other such licenses, one of which was just granted as well. This license is the culmination of more than 3 years’ work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NW Bio.
Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses.
Linda Powers, CEO of NW Bio, commented, “We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K.”
Dr. Mike Scott, President of Advent BioServices, commented, “It is always challenging to be one of the trailblazers. The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license.”
$NWBO @DanaCasullo @wpri12 @GRDecter @cvpayne
1)
Dear anchors in the US!
Do you know what this means?
An american enterprise has created the first personalized cancer vaccine against brain cancer, DCVax-L and gotten approved their facility in Cambridge in the UK.
–> https://t.co/0VsDiw3xGn pic.twitter.com/uYqPbe5uvf
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) March 21, 2023
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Currently trading at a $622 million market valuation NWBO OS is 1,072,879,079 shares. NW Bio is fully reporting OTCQB and an SEC filer and has stated in the past it will pursue a national listing as biotech progresses forward. NWBO has a storied history on the bulletin boards running from as low as a dime several years ago to highs of $2.50 per share in 2020. In May of this year leading up to May 10 NBWO once again spiked from current levels to over $2 per share. The Company also recently completed its manufacturing facility in Sawston, UK and just reported that a MIA license has been approved and issued by the MHRA for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K. This gives NW Bio the green light to move forward with applying for approval of DCVAX by the EMA which is believed the best way for eventual approval in the US. Many top Doctors believe DC-Vax will seriously disrupt and form the GBM treatment landscape moving forward and save millions of lives. Also, the positive top-line data give Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.
American Diversified Holdings Corp (OTCMKTS: ADHC) was operating two e-commerce sites focused on the wellness industry: u
The global CBD pet market size was estimated at USD 195.98 million in 2022 and is expected to grow at a lucrative compound annual growth rate (CAGR) of 31.8% from 2023 to 2030. The market is primarily driven by factors such as rising R&D initiatives, increasing demand, pet humanization, and expenditure. The complexity and uncertainty around regulations, however, is a key restraining factor for the cannabidiol (CBD) pet market. Many CBD companies are thus pursuing certification from veterinary organizations or trusted animal-welfare groups [such as the National Animal Supplement Council (NASC)] to help differentiate their products and assure customers of product quality. 
As a result of its sponsored research partnership agreement entered into with the Reed Research Group out of the University of Wisconsin-Madison to evaluate novel formulations of psilocybin, the Company received its first set of orally dissolvable thin film strips initially to be used to deliver psilocybin and subsequently additional psychedelic-derived medicines.
(v) entered into a sponsored research agreement and an exclusive option to license agreement with North Carolina State University (“NC State”) to develop a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at NC State; and
Revive is led by CEO Derrick Welsh who brings 14 years of Health Care experience, with the past 5 years in the Cannabis industry. Derrick has worked with several high profile publicly traded Cannabis companies like Xanthic Bio Pharma and Green Growth Brands. During this time, he developed several patent pending formulations. The formulations he developed are for water Soluble THC and CBD products such as beverages, water enhancers and effervescent tablets. He has developed quality systems, standard operating procedures and method validation for production of these products. Leveraging his previous experience with cannabinoids Derrick found opportunity in the upcoming psychedelics marketspace. 
Paradise Health & Nutrition’s three stores offer fresh produce, bulk foods, vitamins and supplements, packaged groceries, meat and seafood, deli, baked goods, dairy products, frozen foods, health & beauty products and natural household items.
Additionally, HCMC markets its patented Q-Unit™ and Q-Cup® technology. Information on these products and the technology is available on the Company’s website. 
The decision is contrary to the USPTO’s original decision granting the Company’s patent after examination. The Company continues its efforts to protect its intellectual property and is exploring all of its options including an appeal of the PTAB ruling. In its litigation against Philip Morris, the appeals process continues. 
Jeff Holman, CEO of HCMC, had this to say, “We are pleased to have confidentially submitted the draft registration statement for the spin-off, which we believe will unlock the unrealized value of what we are now calling HCWC. This filing is another milestone for HCMC in its attempts to create shareholder value. As previously disclosed, we intend to distribute 100% of the initially issued common stock in HCWC to our stockholders in the form of a dividend, subject to certain minimum criteria. Separating the natural health food and wellness assets in the form of our brick-and-mortar stores and wellness centers, as well as our online entity at thevitaminstore.com, will create immediate value to our shareholders. The Company is extremely pleased to be continuing to execute on our 4-Point Plan which we released in August 2022.”
HMBL has been building up its Web 3 platform being developed to seamlessly connect consumers and merchants in the digital economy, across its HUMBL Mobile Applications, HUMBL Marketplace and HUMBL Financial divisions. HUMBL Mobile Applications will deliver more seamless global transactions, by integrating multiple currencies, payment methods and financial services into reduced clicks for the customer. HUMBL Marketplace was developed to connect customers and merchants online, in improved global commerce, deal discovery and blockchain tokenization programs. HUMBL Financial has developed new software and algorithms for the digital asset trading markets, which are a new global market for blockchain technologies, and will also offer other credit, lending and financial services.
Earlier this month HMBL announced the launch of its “HUMBL Chat”™ audio rooms integration, providing HUMBL Social users with the ability to create voice chat rooms ranging from individuals and small rooms, to large groups of up to 1,000 people. HUMBL Chat capabilities include peer-to-peer voice rooms with clear, low-latency connections. HUMBL Chat is also pilot testing the ability for users to record audio rooms and save them as .mp3 files, which can be used for archives, interviews, interactive podcasts and transcriptions.
HUMBL CEO Brian Foote said: “HUMBL is the first web3 platform in the world to deliver an integrated digital wallet, search engine, digital payments and a verified social media platform in one place. We believe that the global markets are going to move from traditional banking and middlemen services, to more inclusive digital wallets. Having verified users and merchants on HUMBL, is a natural way for customers around the world to find and send reliable peer payments and transactions between one another without a bank or middleman for verification, sending and settlement. The future intersection of peer, corporate and government transactions moving onto the decentralized blockchain is drawing closer every day. Our mission at HUMBL is provide a digital platform grid where verified users can quickly find, pay and do business with each other across 130+ countries on the blockchain; while driving lower fees, faster settlement times and greater levels of inclusion, versus traditional banking and payment system technologies.”
Today, the global energy system is in the midst of a major transition to clean energy. The efforts of an ever-expanding number of countries and companies to reduce their greenhouse gas emissions to net zero call for the massive deployment of a wide range of clean energy technologies, many of which rely on critical minerals such as copper, lithium, nickel, cobalt and rare earth element. Lithium Corporation’s portfolio of critical mineral prospects (lithium, graphite, rare earth elements) aligns with global sustainability goals. The Company’s North American exploration prospects are vital in the pipeline of secure, domestic supply of critical minerals that will support North American governments, industries, organizations and populations in achieving their sustainability targets.
Lithium Corporation’s Graphite property the BC Sugar is located in the Okanagan Highlands east of Vernon British Columbia and covers around 2,947 acres (1,192 hectares). Highlights include Disseminated large flake graphite (battery grade material) in a weathered matrix. 2015 trenching 100’ (30 meters) 2.73% graphitic carbon. In similar geologic setting as the Black Crystal Graphite operation to the east. Good access on forestry roads from Lumby and Cherry Creek, BC.
Lithium Corporation personnel were on-site during a portion of the San Emidio survey and extracted a mini-bulk sample from the location where brine mineralized with 80 mg/l lithium is known to occur. The sample was shipped to Recion Technologies in Edmonton, Canada, for initial bench tests to determine its amenability to Direct Lithium Extraction (DLE) using Recion’s proprietary technology. Recion continues to work with brine from the Company’s Fish Lake Valley property and recently achieved up to 600% lithium concentration over a period of two hours, extracting up to 95% of the available lithium in the sample submitted. Recion recently completed building a prototype processing plant that conceivably could be utilized on-site for further testing in the future. Preparation is underway and exploratory drilling is slated to begin at Fish Lake Valley in late Q4 2022 or early Q1 2023.
The Company manufactures memory subsystem products at its facility in Suzhou, China which is certified in International Organization for Standardization (“ISO”) 9001:2008 Quality Management Systems and ISO 14001:2004 Environmental Management Standards. Netlists’s in-house manufacturing function, combined with its engineering and design capabilities, allows it to assemble its memory subsystems quickly and in high volume. The Company’s manufacturing facility is capable of surface mount assembly, subsystem testing, system-level burn-in testing, programming, marking, labeling and packaging. Manufacturing cycle times for its memory subsystem products, from receipt of order, are typically one week or less and in some cases as short as two days.
As Netlist product sales continue to grow, the other more exciting part of the Company’s business is its patent infringement lawsuits against Samsung, Micron, Google and others such as Monolithic Power Systems Inc. The financial prospects of Netlist patent infringement lawsuits are significant. Some of the biggest in history are Intel vs VLSI Technology (2021) – $2.18 Billion and Pfizer vs Teva Pharmaceuticals (TEVA) & Sun Pharma (2013) – $2.15B. In June 2020 in a landmark case for the Company, Netlist was victorious in a 12-year battle in the patent courts against Google. A 3-judge panel at the US court of appeals, in a unanimous rule 36 decision, upheld the decision of the lower court and found in favor of Netlist. Google “Waived” their appeal rights to SCOTUS and the 912 patent was reissued with 78 claims upheld.
“Netlist made significant progress in 2022 with its Global IP Enforcement campaign. Our continuing goal is to ensure our innovations are secured by high quality patents and that those patents are being fairly licensed by marketplace implementers…In Netlist’s action against Samsung in the Eastern District of Texas, there were a number of favorable developments in 2022 and now in 2023, we approach the culmination of this case in the form of a jury trial. As a reminder, this case addresses Samsung’s infringement of six Netlist patents covering LRDM, DDR5, and high bandwidth memory, or HBM. In December, the court issued a claim construction order, largely adopting Netlist’s position for many of the claim terms at issue, creating the basis for establishing Samsung’s infringement. More recently, Judge Gilstrap rejected Samsung’s second motion to stay the case and allowed Netlist’s request for additional deposition, testimony and fact discovery.
Ozop is engaged in multiple business lines that include Project Development as well as Equipment Distribution. The Company’s solar and energy storage projects involve large-scale battery and solar photovoltaics (PV) installations. The utility-scale storage business is based on an arbitrage business model in which we install multiple 1+ megawatt batteries, charge them with off-peak grid electricity under contract with the utility, then sell the power back during peak load hours at a premium, as dictated by prevailing electricity tariffs. 
Last year 
In January Ozop signed a multi-year contract with Cirba Solutions, the leading provider of battery management and materials processing services for end-of-life batteries and gigafactory manufacturing scrap, to offer a complete battery recycling program to its extensive dealership network. As electric vehicle (EV) adoption continues to rise in the US, dealerships are increasing their EV offerings and receiving more used EVs from consumers.
In October of 2022 NSAV signed a Definitive Acquisition Agreement for AWC Centralized Cryptocurrency Exchange (AWC) 
In Jannuary RGBP announced the filing of a provisional patent application covering the use of survivin-engineered dendritic cells and exosomes for stimulation of anti-cancer immunity. The intellectual property provides additional means of stimulating specific elements of the immune system to selectively seek and destroy cancer cells without harming healthy tissue. Dendritic cells are the most potent immune cell capable of activating T cells. T cells are the effectors of the immune system and in the present case are the cells that are involved in killing survivin-expressing tumor cells. The cancer marker survivin appears to be present on most of the major cancers but not on non-malignant tissues.
CEO David Koos stated: “The field of immunotherapy is expanding at an unprecedented rate and this is exemplified by the astronomical rise in the use of immunotherapeutic drugs, which now are believed to possess a 100 billion global annual market. Through positioning ourselves to control multiple means of inducing immunity to survivin, we are seeking to concurrently advance our science, diversify our portfolio and provide possible new revenue streams to shareholders.”