Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis

JERUSALEM, Nov. 09, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, reports today that the American Society for Bone and Mineral Research (ASBMR) has announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs.

BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on December 13, 2016, to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

"This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies. We would like to sincerely acknowledge and thank the ASBMR–FNIH–SABRE team for its significant contributions and for furthering this key initiative with the FDA," said Miranda Toledano, Chief Executive Officer of Entera. "The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR–SABRE BMD endpoint. We have powered our proposed phase 3 study using the published SABRE quantitative thresholds which statistically correlate to reductions in vertebral, non–vertebral and all site fracture risk. Much like biomarkers and validated surrogates that are routinely used across oncology, cardiovascular and metabolic disorders, we look forward to FDA's potential qualification of BMD for osteoporosis and to promptly advancing EB613 forward using this more ethical approach," said Ms. Toledano.

EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for osteoporosis. In a phase 2, 6–month, 161–patient, placebo–controlled study EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting, Entera announced FDA's concurrence that a 2–year, placebo–controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support an NDA for EB613.

About ASBMR–FNIH SABREi

Initiated in 2013, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Bone Quality Project assembled data from more than 150,000 participants across more than 50 clinical trials of anti–osteoporosis drugs. The project team re–evaluated these existing data to understand which measurements could predict the ability of the treatment to reduce fractures. The study findings identified an increase in bone mineral density, as measured by a low–dose X–ray imaging technique, as a strong predictor of the extent to which treatments reduce fracture risk. A change in bone mineral density could therefore be used in future clinical trials to determine the effectiveness of osteoporosis drugs. Through a partnership with ASBMR, the FNIH extended and continues to support the original study, renamed SABRE, to seek FDA approval for the surrogate biomarker.

About the Cures Act

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision–making process. Cures enhances our ability to modernize clinical trial designs, including the use of real–world evidence, and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

______________________________
i
https://www.asbmr.org/about/news–release–detail/asbmr–sabre–team–submits–full–qualification–plan–t


GLOBENEWSWIRE (Distribution ID 8976760)

DOCN DEADLINE NOTICE: ROSEN, RECOGNIZED INVESTOR COUNSEL, Encourages DigitalOcean Holdings, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important November 13 Deadline in Securities Class Action – DOCN

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of DigitalOcean Holdings, Inc. (NYSE: DOCN) between February 16, 2023 and August 25, 2023, both dates inclusive (the "Class Period"), of the important November 13, 2023 lead plaintiff deadline.

SO WHAT: If you purchased DigitalOcean securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the DigitalOcean class action, go to https://rosenlegal.com/submit–form/?case_id=18119 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 13, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, throughout the Class Period, defendants made materially false and/or misleading statements and/or failed to disclose that: (1) defendants lacked the skills and experience to assess complicated tax matters and therefore did not design or maintain effective controls over DigitalOcean's accounting for income taxes; and (2) as a result of the foregoing, defendants' financial statements during the Class Period were inaccurate and materially misleading. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the DigitalOcean class action, go to https://rosenlegal.com/submit–form/?case_id=18119 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8976627)

ROSEN, A LEADING LAW FIRM, Encourages Lumen Technologies, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important November 14 Deadline in Securities Class Action – LUMN

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Lumen Technologies, Inc. (NYSE: LUMN) between March 11, 2019 and July 14, 2023, both dates inclusive (the "Class Period"), of the important November 14, 2023 lead plaintiff deadline.

SO WHAT: If you purchased Lumen securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Lumen class action, go to https://rosenlegal.com/submit–form/?case_id=17736 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 14, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that: (1) Lumen owned and/or still owns thousands of miles of cables wrapped in lead, a known neurotoxin, within the United States of America; (2) the foregoing has harmed and posed the risk of further harming the environment, exposed Lumen employees, and the general public, thereby posing a significant public health risk and environmental pollution risk; (3) Lumen was on notice about the damage and risks presented by these lead–covered cables but did not disclose them as a potential threat to everyday people and communities, as well as failed to provide adequate lead training to employees; (4) all the foregoing subjected Lumen to a heightened risk of governmental and regulatory oversight and enforcement action, as well as legal and reputational harm; and (5) as a result, Lumen's public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Lumen class action, go to https://rosenlegal.com/submit–form/?case_id=17736 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8976647)

Nigerian Lawyer Zannah Bukar Mustapha Receives Prestigious Global Citizen Award

LONDON, Nov. 09, 2023 (GLOBE NEWSWIRE) — Internationally recognized humanitarian, philanthropist, and Founder of the Future Prowess Foundation School for orphans and less privileged children Zannah Bukar Mustapha has been named as the 2023 recipient of the Global Citizen Award, an annual tribute presented by leading international residence and citizenship advisory firm Henley & Partners, in partnership with the Swiss non–profit humanitarian organization Andan Foundation.

The prestigious award, which honors an individual who shows exceptional courage and commitment towards improving and supporting the global community, was presented at a gala reception during the 17th annual Global Citizenship Conference at the Shangri–La Hotel DIFC in Dubai, UAE, attended by heads of government, policymakers, leading academics, private client advisors, family offices, as well as many wealthy entrepreneurs and investors.

Mr. Mustapha played a critical role in mediating the release of over 100 of the Chibok school girls who were kidnapped by Islamic insurgency group Boko Haram in a remote part of Nigeria in April 2014, giving rise to the international #BringBackOurGirls campaign. The school he founded in 2007 in Maiduguri "" the capital of Borno State and the epicenter of the Boko Haram rebellion "" provides free education, meals, uniforms, and healthcare to children on both sides of the conflict as a sign of the reconciliation he hopes to achieve in the region.

Chairman of Henley & Partners and Founder of the Andan Foundation Dr. Christian H. Kaelin says Mr. Mustapha is a most worthy and inspiring recipient of the award. "As a champion for the safety and education rights of all displaced and orphaned children afflicted by the brutal violence in Northern Nigeria, Mr. Mustapha has demonstrated vision, exceptional courage, and innovation in driving change, and his actions and outlook are a valuable contribution towards a more just, peaceful, and tolerant world. He is a true "game changer,' bridging gender, political, and religious divides by helping children on both sides of the conflict come together and learn under the same roof. We need more Zannah Mustaphas in the world."

The Global Citizen Award selection process is based on a majority decision of the Global Citizen Award Committee. The award itself consists of a bespoke sculptural medal designed by leading Italian artist Antonio Nocera, an award certificate signed by the Chairman of the Global Citizen Award Committee, and a monetary prize of USD 25,000, which goes towards supporting the awardee's humanitarian efforts. In addition, Henley & Partners commits to working closely with the awardee for a period of one year, raising awareness of their work and supporting the selected project through the firm's network of more than 40 offices worldwide.

Since its inception, the Global Citizen Award has honored many remarkable individuals. The first laureate was German entrepreneur Harald Hppner, who set up the refugee humanitarian aid project Sea–Watch. Other previous recipients are Dr. Imtiaz Sooliman, Founder of the Gift of the Givers Foundation, Africa's largest disaster relief organization, and Monique Morrow, Co–Founder of The Humanized Internet, a digital identity project that aims to bring hope to the estimated 1.1 billion individuals in the world who cannot prove their legal identity. Diep Vuong, Co–Founder and President of the Pacific Links Foundation, was awarded for her work in Southeast Asia, campaigning for the rights of those enslaved by human trafficking, and Prof. Dr. Padraig O'Malley received his Global Citizen Award in recognition of his work on conflict resolution and reconciliation in Iraq, Northern Ireland, and South Africa.

Thanking Henley & Partners and the Andan Foundation for their recognition of his work, Mr. Mustapha said, "Humanity's interconnectedness in the global data sphere is now undeniable, constituting an expansive realm with limitless possibilities. In contrast, the unity among races, ethnicities, and citizens has grown increasingly delicate. Only global citizenship can heal."

Media Contact:

Sarah Nicklin

Group Head of Public Relations

sarah.nicklin@henleyglobal.com

Mobile: +27 72 464 8965

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/73067ec7–8285–4333–849a–48dc9724ce41


GLOBENEWSWIRE (Distribution ID 1000898595)

OPEN Health Presenting Innovative Research on Capitalizing Data for Patient Access at ISPOR Europe

London, Nov. 09, 2023 (GLOBE NEWSWIRE) —
London, UK "" November 9, 2023 "" OPEN Health, a preeminent global provider of consulting, HEOR and market access, patient engagement, and scientific and creative communications services, will be presenting innovative research at the upcoming ISPOR Europe conference in Copenhagen, Denmark. OPEN Health experts will contribute to the event through workshops, panel discussions, and 24 posters. Key themes of OPEN Health's research presented this year are patient preference, advanced modeling methodologies, and HTA policy changes. The majority of OPEN Health's Scientific Office will be onsite to discuss the role of HEOR science in shaping policy, including Dr. Elisabeth Fenwick, Chief Scientific Officer; Professor Ben van Hout, Scientific Founder; Dr. Marco Boeri, Director of Preference Research and scientific lead for Patient–Centered Outcomes; Emanuele Arc, MSc, Senior Research Consultant in Strategic Market Access; and Maarten Treur, MSc, Vice President and Global Head of Modeling & Meta–Analysis.

Dr. Elisabeth Fenwick, Chief Scientific Officer at OPEN Health, said: "I am extremely proud to see the research we do at OPEN Health being presented by our scientific experts at the ISPOR EU conference in Copenhagen. The range of research topics covered this year shows the extent of our expertise in advanced techniques as well as key therapeutic areas."

Dr. Marco Boeri, Director of Preference Research and scientific lead for Patient–Centered Outcomes at OPEN Health, said: "The importance of patient preference information is that it brings a systematic approach to implement the idea of patient–focused drug development promoted by the FDA, the EMA, and various HTA bodies around the world. Indeed, the patient voice is key to patient adherence, and by helping to understand unmet needs, it is key to the success of a pharmaceutical product."

Emanuele Arc, MSc, Senior Research Consultant in Strategic Market Access, said: "We are in a dynamic period of policy changes for access and HTA across regional, national, and international settings. HTA is taking a more prominent role in ensuring sustainable access to health innovations, while health innovations become exponentially more complex and expensive. We at OPEN Health are committed to understanding and shaping such changes through research and stakeholder engagement."

OPEN Health will be presenting a virtual panel on November 10, ahead of ISPOR, on: "EU HTA Joint Clinical Assessments: Navigating Potential Challenges Ahead of 2025." The panel is set to discuss several policy aspects regarding the current challenges and implications of the EU HTA regulation, covering topics such as the current position of EU HTA implementation, the major challenges expected across the industry, the stance of member states and various stakeholders, and strategies for the industry to prepare for joint clinical assessments. Register now to save your seat.

To learn more about our presence at ISPOR Europe, visit our website or meet the OPEN Health team at booth #C2–012 in Copenhagen.

About OPEN Health

OPEN Health unites deep scientific knowledge with wide–ranging specialist expertise to unlock possibilities that improve health outcomes and patient well–being. Working in partnership with our clients, we embrace our different perspectives and strengths to deliver fresh thinking and solutions that make a difference. OPEN Health is a flexible global organization that solves complex healthcare challenges across consulting, HEOR and market access, scientific communications, patient engagement, and creative omnichannel communications. For more information on OPEN Health, visit www.openhealthgroup.com.

Press contact:

OPEN Health

Candice Subero, Vice President, Global Marketing

candicesubero@openhealthgroup.com

Attachment


GLOBENEWSWIRE (Distribution ID 8976596)

Mobile Ultra: Advancing Digital Investigations in the Age of Evolving Technology

TYSONS CORNER, Va. and PETAH TIKVA, Israel, Nov. 09, 2023 (GLOBE NEWSWIRE) — Cellebrite DI Ltd. (Nasdaq: CLBT), a global leader in Digital Intelligence (DI) solutions for the public and private sectors, announced today the release of Mobile Ultra, for mobile device investigations to the private sector. An all–in–one application, Mobile Ultra surfaces facts quickly and accelerates the collection, extractions and reporting process during corporate investigations.

In a fast–paced global economy, corporations, law firms and service providers require innovative, fast and easy approaches for collecting data from mobile devices while keeping pace with technological advancements. Mobile Ultra provides answers to the time–sensitive, critical challenges that corporate investigators often encounter with mobile devices, including the need to quickly find evidence and identify potential missing critical data, all while ensuring that the data is defensible and court–ready.

Mobile Ultra offers a user–friendly interface that seamlessly combines the best features of collection, analysis and review tools, streamlining investigative workflows. It enables investigators to decode and parse data from the widest array of Apple and Android software and devices, enabling industry–leading data analysis. The solution offers full file system extractions enabling comprehensive analysis of the information residing on a mobile device. Additionally, Mobile Ultra provides access to data from more than 50 cloud sources, short–lived messages, third–party chat applications and deleted content, enhancing the probability of discovering crucial evidence.

"Mobile Ultra continues to lead the industry for e–Discovery, corporate investigations and incident response by surpassing previous limitations and providing greater access to comprehensive and accurate data that is fully defensible," said Ken Basore, General Manager, Cellebrite Enterprise Solutions. "The industry is facing a myriad of challenges including evolving devices and apps, increasing data volumes and deleted data. We're proud to say Mobile Ultra is the all–in–one solution to address these complex problems."

In an era where digital investigations play a pivotal role in addressing costly, time–consuming litigation that can impact the business, Mobile Ultra aims to equip investigative professionals with the necessary tools to navigate this evolving landscape effectively. It ensures examiners have the capability to quickly and efficiently uncover all pertinent data, maintaining the highest standards of accuracy and integrity.

To find out more about how Mobile Ultra can advance your investigations, visit our Mobile Ultra webpage.

About Cellebrite

Cellebrite's (Nasdaq: CLBT) mission is to enable its customers to protect and save lives, accelerate justice, and preserve privacy in communities around the world. We are a global leader in Digital Intelligence solutions for the public and private sectors, empowering organizations in mastering the complexities of legally sanctioned digital investigations by streamlining intelligence processes.

Trusted by thousands of leading agencies and companies worldwide, Cellebrite's Digital Intelligence platform and solutions transform how customers collect, review, analyze and manage data in legally sanctioned investigations. To learn more visit us at www.cellebrite.com, https://investors.cellebrite.com, or follow us on Twitter at @Cellebrite.

About Cellebrite Enterprise Solutions

In a world that's evolving rapidly, Cellebrite Enterprise Solutions looks beyond the horizon to design solutions to keep data within reach, transform it and reveal important insights to protect your business and employees. From headquarters to home office, eDiscovery professionals and corporate investigators can access endpoints anywhere with Cellebrite's enterprise solution offerings.

Cellebrite Contacts

Media
Victor Cooper
Sr. Director of Corporate Communications + Content Operations
Victor.cooper@cellebrite.com
+1 404.804.5910

Investors
Andrew Kramer
VP, Investor Relations
Investors@cellebrite.com
+1 973.206.7760


GLOBENEWSWIRE (Distribution ID 8975976)

Recursion Announces Data Collaboration Deal with Tempus, Top 50 Supercomputer Ambition Powered by NVIDIA, and Updated Focus of Collaboration with Bayer to Precision Oncology

SALT LAKE CITY, Nov. 09, 2023 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced two significant updates with their collaborators NVIDIA and Bayer, and a new collaboration with Tempus Labs as it creates infrastructure and expands its ambitions and scope in the precision oncology space.

"Since our founding we have believed that the next generation of biopharma leaders would operate at the intersection of scaled datasets and accelerated computing," said Chris Gibson, Ph.D., Co–founder and CEO of Recursion. "Today, we are thrilled to share three major initiatives that support this belief and our mission to bring better medicines to patients at speed and scale. With Tempus's 20 petabytes of fit–for–purpose precision oncology data, NVIDIA's support in quadrupling our supercomputing power to rapidly and reliably advance the exploration and construction of large AI models, and updating our collaboration with Bayer to rapidly pursue a set of precision oncology programs, we will continue to drive the transformation from BioTech to TechBio together."

Tempus Collaboration Provides Recursion with Access to Data Containing More Than 20 Petabytes of Proprietary Patient–Centric Oncology Data

Recursion has come to an agreement with Tempus for preferred access to one of the world's largest proprietary, de–identified, patient–centric oncology datasets, spanning DNA, RNA, health records and more to support the discovery of potential biomarker–enriched therapeutics at scale through the training of causal AI models. By combining the forward genetics approach of Tempus with the reverse genetics approach at Recursion, the company believes it has an opportunity to improve the speed, precision and scale of therapeutic development in oncology. As part of the agreement, Recursion will pay Tempus up to $160M in cash or equity over the next five years in exchange for continued and updated data access and use rights for therapeutic development purposes.

"We share Recursion's commitment to a data–first approach to precision medicine," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working in tandem to leverage our multi–modal data to uncover insights that have the potential to advance personalized therapeutics for patients around the world."

In aggregate, Recursion will now have access to approximately 50 petabytes of proprietary data across biology and chemistry as well as real–world, patient–centric data that is relatable and fit for the purpose of training large–scale AI/ML models, which it plans to use to drive novel therapeutic hypotheses, biomarker strategies, and patient cohort selection.

Top 50 Supercomputer Powered by NVIDIA

To accelerate the impact of the proprietary data Recursion has accumulated, the company has committed to substantially expanding BioHive–1, its on–premise NVIDIA DGX SuperPOD–based supercomputer, adding over 500 NVIDIA H100 Tensor Core GPUs to the more than 300 NVIDIA A100 Tensor Core GPUs already in place to increase its computational capacity 4X. This greatly expanded compute power will support the company's pipeline, partnerships, and the construction of one of the largest foundation models of its kind across multiple modalities of biology and chemistry.

Based on the June 2023 TOP500 list, Recursion projects that upon completion and benchmarking, BioHive–1 will likely be in the top 50 most powerful supercomputers in the world across any industry and would be the most powerful supercomputer owned and operated by any biopharma company. The company anticipates the enhancement of BioHive–1 to be operational in the first half of 2024.

"A new era in drug discovery is here, and life science and drug discovery companies are leading the way," said Jensen Huang, founder and CEO of NVIDIA. "Our ongoing collaboration with Recursion will bring scaled biological data together with one of the most powerful supercomputers to decode biology and get to better medicines faster."

Collaboration with Bayer in Precision Oncology Programs

Recursion announced an updated collaboration with its established partner, Bayer, for a select set of precision oncology programs. This decision allows Bayer to leverage Recursion's state–of–the–art capabilities to identify novel targets and chemistry applicable to oncology indications. Under the terms of the agreement, the companies may initiate up to seven oncology programs and Recursion is eligible to receive potential, success–based, future payments of up to $1.5 billion plus royalties on net sales.

"Our collaboration with Recursion is a testament to our commitment to shape the future of healthcare, using advancements in AI and drug discovery to push the boundaries of medicine with the aim of providing innovative cancer therapies for patients whose medical needs are not yet met by today's treatment options," said Stefan Oelrich, Member of the Board of Bayer AG and President, Pharmaceuticals.

About Recursion
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale "" up to millions of wet lab experiments weekly "" and massive computational scale "" owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montral and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on Twitter and LinkedIn.

Forward–Looking Statements
This document contains information that includes or is based upon “forward–looking statements'' within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the outcomes and benefits expected from access to the real–world multimodal data held at Tempus; outcomes and benefits of deriving therapeutic hypotheses by linking molecular data and outcomes data; outcomes and benefits of expanding our supercomputer; early and late stage discovery, preclinical, and clinical programs, including timelines for data readouts; licenses and collaborations, including option exercises by partners and additional partnerships; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance, including cash runway; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as "plan," "will," "expect," "anticipate," "intend," "believe," "potential," "could," "continue," and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Quarterly Report on Form 10–Q and our Annual Report on Form 10–K. All forward–looking statements are based on management's current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

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GLOBENEWSWIRE (Distribution ID 8976094)

Pacific Green Enters Agreement to Secure Strategic Site to Develop 0.5GW / 1.0GWh Battery Energy Park in South Australia

Dover, DE, Nov. 09, 2023 (GLOBE NEWSWIRE) — / Pacific Green Technologies, Inc. (“Pacific Green”), (OTCQB: PGTK) announces that Pacific Green Technologies (Australia) Pty Ltd., a wholly owned subsidiary of Pacific Green, has entered into an exclusivity agreement to secure a strategically located land site in Limestone Coast, South Australia to develop a 0.5 GW / 1.0 GWh battery energy park (the "Project").

The Project will commence construction in 2024, with the energy park anticipated to be operational in 2026. When completed it will be the largest battery park in South Australia, connecting directly into an existing 275 kVA substation.

The Project will deliver a major increase in energy storage capacity in South Australia, reducing wholesale energy costs for the state, while also strengthening the region's energy stability for communities and supporting South Australia's net–zero transition.

Joel Alexander, Pacific Green's Managing Director, Australia, commented: "We are excited to grow our portfolio into South Australia, which already has the highest adoption of renewable generation of all states in Australia. Our Limestone Coast Battery Energy Park can act as a load during the day, increasing the viability of even more solar and wind generation, whilst shifting energy to the times it is most valuable in the evening peak. This momentum allows us to accelerate progress towards South Australia achieving 100% net renewables by 2030.

Scott Poulter, Pacific Green's CEO, added: "Coupled with our energy parks in Portland, Victoria, this agreement cements Pacific Green's multi–gigawatt platform that will be deployed across Australia in the coming months and years."

About Pacific Green Technologies, Inc.:

Pacific Green is focused on addressing the world's need for cleaner and more sustainable energy. It offers grid–scale battery energy storage systems, renewable and environmental technologies.

For more information, visit Pacific Green's website:
www.pacificgreen.com

Notice Regarding Forward–Looking Statements:

This news release contains "forward–looking statements," as that term is defined in Section 27A of the United States Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this news release which are not purely historical are forward–looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward–looking statements include, among other things, the continued development of the Project, any potential business developments and future interest in Pacific Green's battery, solar and environmental technologies.

Actual results could differ from those projected in any forward–looking statements due to numerous factors. Such factors include, among others, the continuation of the development of the Project, general economic and political conditions. These forward–looking statements are made as of the date of this news release, and Pacific Green assumes no obligation to update the forward–looking statements, or to update the reasons why actual results could differ from those projected in the forward–looking statements. Although Pacific Green believes that the beliefs, plans, expectations and intentions contained in this news release are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all the information set forth herein and should also refer to the risk factors disclosure outlined in Pacific Green's annual report on Form 10–K for the most recent fiscal year, Pacific Green's quarterly reports on Form 10–Q and other periodic reports filed from time–to–time with the Securities and Exchange Commission.


GLOBENEWSWIRE (Distribution ID 8976395)

Israel’s Military Is Part of the U.S. War Machine

A U.S. Air Force F-16 Fighting Falcon from the 510th Fighter Squadron takes off as part of exercise Agile Buzzard at Decimomannu Air Base, Italy, Jan. 14, 2020. (U.S. Air Force photo by Staff Sgt. Heidi Goodsell)

By Norman Solomon
SAN FRANCISCO, USA, Nov 9 2023 – The governments of Israel and the United States are now in disagreement over how many Palestinian civilians it’s okay to kill. Last week — as the death toll from massive Israeli bombardment of Gaza neared 10,000 people, including several thousand children — top U.S. officials began to worry about the rising horrified outcry at home and abroad. So, they went public with muted misgivings and calls for a “humanitarian pause.” But Israel’s Prime Minister Benjamin Netanyahu made clear that he would have none of it.

Such minor tactical discord does little to chip away at the solid bedrock alliance between the two countries, which are most of the way through a 10-year deal that guarantees $38 billion in U.S. military aid to Israel. And now, as the carnage in Gaza continues, Washington is rushing to provide extra military assistance worth $14 billion.

Days ago, In These Times reported that the Biden administration is seeking congressional permission “to unilaterally blanket-approve the future sale of military equipment and weapons — like ballistic missiles and artillery ammunition — to Israel without notifying Congress.” And so, “the Israeli government would be able to purchase up to $3.5 billion in military articles and services in complete secrecy.”

While Israeli forces were using weapons provided by the United States to slaughter Palestinian civilians, resupply flights were landing in Israel courtesy of U.S. taxpayers. Air & Space Forces Magazine published a photo showing “U.S. Air Force Airmen and Israeli military members unload cargo from a U.S. Air Force C-17 Globemaster III on a ramp at Nevatim Base, Israel.”

Pictures taken on Oct. 24 show that the military cargo went from Travis Air Force Base in California to Ramstein Air Base in Germany to Israel. Overall, the magazine reported, “the Air Force’s airlift fleet has been steadily working to deliver essential munitions, armored vehicles, and aid to Israel.” And so, the apartheid country is receiving a huge boost to assist with the killing.

The horrific atrocities committed by Hamas on Oct. 7 have opened the door to protracted horrific atrocities by Israel with key assistance from the United States.

Oxfam America has issued a briefing paper decrying the Pentagon’s plans to ship tens of thousands of 155mm artillery shells to the Israeli military. The organization noted that “Israel’s use of this munition in past conflicts demonstrates that its use would be virtually assured to be indiscriminate, unlawful, and devastating to civilians in Gaza.”

Oxfam added: “There are no known scenarios in which 155mm artillery shells could be used in Israel’s ground operation in Gaza in compliance with international humanitarian law.”

During the last several weeks, “international humanitarian law” has been a common phrase coming from President Biden while expressing support for Israel’s military actions. It’s an Orwellian absurdity, as if saying the words is sufficient while constantly helping Israel to violate international humanitarian law in numerous ways.

“Israeli forces have used white phosphorus, a chemical that ignites when in contact with oxygen, causing horrific and severe burns, on densely populated neighborhoods,” Human Rights Watch senior legal adviser Clive Baldwin wrote in late October. “White phosphorus can burn down to the bone, and burns to 10 percent of the human body are often fatal.”

Baldwin added: “Israel has also engaged in the collective punishment of Gaza’s population through cutting off food, water, electricity, and fuel. This is a war crime, as is willfully blocking humanitarian relief from reaching civilians in need.”

At the end of last week, the Win Without War organization noted that “senior administration officials are increasingly alarmed by how the Israeli government is conducting its military operations in Gaza, as well as the reputational repercussions of the Biden administration’s support for a collective punishment strategy that clearly violates international law. Many worry that the U.S. will be blamed for the Israeli military’s indiscriminate attacks on civilians, particularly women and children.”

News reporting now tells us that Biden and Secretary of State Antony Blinken want a bit of a course correction. For them, the steady large-scale killing of Palestinian civilians became concerning when it became a PR problem.

Dressed up in an inexhaustible supply of euphemistic rhetoric and double-talk, such immoral policies are stunning to see in real time. And, for many people in Gaza, literally breathtaking.

Now, guided by political calculus, the White House is trying to persuade Israel’s prime minister to titrate the lethal doses of bombing Gaza. But as Netanyahu has made clear in recent days, Israel is going to do whatever it wants, despite pleas from its patron.

While, in effect, it largely functions in the Middle East as part of the U.S. war machine, Israel has its own agenda. Yet the two governments are locked into shared, long-term, overarching strategic interests in the Middle East that have absolutely no use for human rights except as rhetorical window-dressing.

Biden made that clear last year when he fist-bumped the de facto ruler of oil-rich Saudi Arabia, a dictatorship that — with major U.S. assistance — has led an eight-year war on Yemen costing nearly 400,000 lives.

The war machine needs constant oiling from news media. That requires ongoing maintenance of the doublethink assumption that when Israel terrorizes and kills people from the air, the Israeli Defense Force is fighting “terrorism” without engaging in it.

Another helpful notion in recent weeks has been the presumption that — while Hamas puts out “propaganda” — Israel does not. And so, on Nov. 2, the PBS NewsHour’s foreign affairs correspondent Nick Schifrin reported on what he called “Hamas propaganda videos.”

Fair enough. Except that it would be virtually impossible for mainstream U.S. news media to also matter-of-factly refer to public output from the Israeli government as “propaganda.” (I asked Schifrin for comment, but my several emails and texts went unanswered.)

Whatever differences might surface from time to time, the United States and Israel remain enmeshed. To the power elite in Washington, the bilateral alliance is vastly more important than the lives of Palestinian people. And it’s unlikely that the U.S. government will really confront Israel over its open-ended killing spree in Gaza.

Consider this: Just weeks before beginning her second stint as House speaker in January 2019, Rep. Nancy Pelosi was recorded on video at a forum sponsored by the Israeli American Council as she declared: “I have said to people when they ask me — if this Capitol crumbled to the ground, the one thing that would remain is our commitment to our aid, I don’t even call it aid — our cooperation — with Israel. That’s fundamental to who we are.”

Even making allowances for bizarre hyperbole, Pelosi’s statement is revealing of the kind of mentality that continues to hold sway in official Washington. It won’t change without a huge grassroots movement that refuses to go away.

Norman Solomon is the national director of RootsAction.org and executive director of the Institute for Public Accuracy. He is the author of many books including War Made Easy. His latest book, War Made Invisible: How America Hides the Human Toll of Its Military Machine, was published in summer 2023 by The New Press.

IPS UN Bureau

 


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Arms Suppliers to Israel & Hamas Should Face War Crime Charges—But Will They?

A night-time bombardment of Gaza City. Credit: UNICEF/Eyad El Baba

By Thalif Deen
UNITED NATIONS, Nov 9 2023 – The killings of thousands of civilians in the ongoing Middle East conflict are largely the result of an uneven battle—a nuclear-armed Israel, equipped with some of the most sophisticated American weapons systems, fighting a rag-tag militant group, Hamas.

Against this backdrop, a leading human rights organization, is appealing to Israel’s key allies—including the US, UK, Canada and Germany—to suspend military assistance and arms sales to Israel “so long as its forces commit widespread, serious abuses amounting to war crimes against Palestinian civilians with impunity”.

Iran and other governments, says Human Rights Watch (HRW), should also cease providing arms to Palestinian armed groups, including Hamas and Islamic Jihad, so long as they systematically commit attacks amounting to war crimes against Israeli civilians.

But the killings by the Israelis far outnumber the killings by Hamas, according to conservative estimates. Since October 7, about 1,400 Israelis and other nationals have been killed, and more than 10,000 Palestinians,40 percent of them children.

“Civilians are being punished and killed at a scale unprecedented in recent history in Israel and Palestine,” said Bruno Stagno, chief advocacy officer at Human Rights Watch. “The United States, Iran and other governments risk being complicit in grave abuses if they continue to provide military assistance to known violators.”

Kenneth Roth, the former executive director of HRW, was quoted as saying Israel dropping several large bombs in the middle of a densely populated refugee camp was completely and predictably going to lead to a significant and disproportionate loss of civilian lives and therefore a war crime.

Describing Israel’s military “as part of the US war machine”, Norman Solomon, national director of RootsAction.org and executive director of the Institute for Public Accuracy, told IPS the solid bedrock alliance between Israel and the US has ensured the continuation of a 10-year deal that guarantees $38 billion in U.S. military aid to Israel.

And now, as the carnage in Gaza continues, he pointed out, Washington is rushing to provide extra military assistance worth $14 billion.

During the last several weeks, he said, “international humanitarian law” has been a common phrase coming from President Biden while expressing support for Israel’s military actions.

It’s an Orwellian absurdity, as if saying the words is sufficient, while constantly helping Israel to violate international humanitarian law in numerous ways, declared Solomon.

HRW said future military transfers to Israel in the face of ongoing serious violations of the laws of war risk making the United States, the United Kingdom, Canada, and Germany complicit in these abuses if they knowingly and significantly contribute to them. Providing weapons to Palestinian armed groups, given their continuing unlawful attacks, risks making Iran complicit in those violations.

US President Joseph R. Biden has requested US$14.3 billion for further arms to Israel in addition to the $3.8 billion in US military aid Israel receives annually.

On November 2, the US House of Representatives passed a bill that would provide that military aid to Israel. Since October 7, the United States has either transferred or announced it is planning to transfer Small Diameter Bombs, Joint Direct Attack Munition (JDAM) guidance kits, 155mm artillery shells, and a million rounds of ammunition, among other weapons.

The United Kingdom has licensed the sale of GBP£442 million worth of arms ($539 million) to Israeli forces since 2015, including aircraft, bombs, and ammunition. Canada exported CDN$47 million ($33 million) in 2021 and 2022. Germany issued licenses for €862 million ($916 million) in arms sales to Israel between 2015 and 2019, according to HRW.

Hamas leadership publicly said in January 2022 that it received at least US$70 million in military assistance from Iran, but did not specify during what period of time this support was provided.

“How many more civilian lives must be lost, how much more must civilians suffer as a result of war crimes before countries supplying weapons to Israel and Palestinian armed groups pull the plug and avoid complicity in these atrocities?” Stagno said.

The United Nations, once described the deaths and destruction in the eight-year-old civil war in Yemen as “the world’s worst humanitarian disaster”.

The killings of mostly civilians have been estimated at over 100,000, with accusations of war crimes against a coalition led by Saudi Arabia and the United Arab Emirates (UAE), whose primary arms supplier is the US.

And now, the killings of Palestinians in Gaza have come back to haunt the Americans in a new war zone. But still, the US is unlikely to be hauled before the International Criminal Court (ICC)., nor was it charged for human rights abuses, torture, and war crimes committed in Afghanistan and Iraq in a bygone era.

“If U.S. officials don’t care about Palestinian civilians facing atrocities using U.S. weapons, perhaps they will care a bit more about their own individual criminal liability for aiding Israel in carrying out these atrocities,” said Sarah Leah Whitson, executive director of Democracy for the Arab World Now (DAWN), an American non-profit organization that advocates democracy and human rights in the Middle East.

“The American people never signed up to help Israel commit war crimes against defenseless civilians with taxpayer funded bombs and artillery,” she noted.

Last month, Josh Paul, a longstanding official at the State Department’s political-military bureau resigned because of what he said was immoral US support and lethal aid for Israel’s bombings in Gaza.

According to the State Department, Israel has been designated as a Major Non-NATO Ally under U.S. law. This status provides foreign partners with certain benefits in the areas of defense trade and security cooperation and is a powerful symbol of their close relationship with the United States.

Consistent with statutory requirements, it is the policy of the United States to help Israel preserve its Qualitative Military Edge (QME), or its ability to counter and defeat any credible conventional military threat from any individual state or possible coalition of states or from non-state actors, while sustaining minimal damages and casualties.

This requires a quadrennial report to Congress, for arms transfers that are required to be Congressionally notified, and a determination that individual arms transfers to the region will not adversely affect Israel’s QME.

Strengthening their military relationship further, the United States and Israel have signed multiple bilateral defense cooperation agreements, including: a Mutual Defense Assistance Agreement (1952); a General Security of Information Agreement (1982); a Mutual Logistics Support Agreement (1991); and a Status of Forces Agreement (1994).

IPS UN Bureau Report

 


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