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Tonix Pharmaceuticals begins Phase 1 trial of TNX-1500 in healthy participants

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the company has initiated a Phase 1 clinical study involving TNX-1500 in healthy volunteers, focusing on single ascending dose escalation. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500. TNX-1500 is a pharmaceutical product under development for the prevention of kidney transplant rejection, as well as other potential indications related to transplantation and autoimmune disorders. Lederman highlighted that recent animal studies have shown promising results, indicating that TNX-1500 has the potential to prevent organ rejection and maintain graft function, either as a standalone treatment or when combined with other drugs. The Phase 1 study will involve the evaluation of eligible participants over a 120-day period after dosing, with a target enrollment of 36 participants. The initiation of this Phase 1 study is a crucial step towards supporting the dosing regimen for an upcoming Phase 2 trial involving kidney transplant recipients. Tonix Pharmaceuticals is optimistic about TNX-1500's potential to improve long-term graft survival with reduced toxicity compared to current immunosuppressive treatments. Additionally, the company believes that TNX-1500 could address various indications, including autoimmune diseases beyond transplantation. Contact Details Proactive Studio +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:18 PM Eastern Daylight Time

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Immunic CEO hails "great day" after completing IMU-838 phase 2 trial enrolment

Immunic Inc

Immunic Inc (NASDAQ:IMUX) President and CEO Dr Daniel Vitt speaks to Thomas Warner from Proactive after the biotechnology company announced the completion of the enrolment of its phase 2 CALLIPER trial of lead asset vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). Dr Vitt explains that 467 patients have been enrolled across various sub-indications including primary progressive, secondary active, and non-active secondary progressive MS. He calls it a "great day for the programme." The trial aims to assess the efficacy of IMU-838 and Dr. Vitt highlights the focus on biomarkers, particularly the neurofilament light chain (NFL), a protein indicative of active disease. Anticipated next steps include an interim analysis set for release this fall, which will examine biomarker benefits for different sub-indications. Dr. Vitt also reflects on what he considers a successful 2023 so far, with positive data emerging from Immunic's colitis maintenance and IMU-856 celiac disease programs. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

August 21, 2023 08:00 AM Eastern Daylight Time

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Nearly 2 In 5 American Workers Are Now Freelance – Here’s How They’re Keeping Dental Costs Down Even Without Employer-Sponsored Dental Insurance

DentalPlans.com

By Rachael Green, Benzinga In the first year of the pandemic, approximately 2 million Americans switched from traditional employment to freelance or contract jobs bringing the total percentage of the U.S. workforce that freelances from 28% in 2019 to 36% in 2020. By 2022, that percentage had grown to 39% — or 60 million Americans — suggesting that the trend is here to stay even as other parts of the economy return to their pre-pandemic norm. While freelance or contract work brings flexibility and more control over work/life balance to American workers, it also often places the costly burden of paying for insurance entirely out of pocket. The average monthly premium contribution employees pay for employer-sponsored plans is $110 for single coverage. Meanwhile, self-employed workers pay an average of $560 for the same coverage. That’s not even counting dental insurance, which can add another $46 to the monthly insurance bill for a self-employed person – more if they need to provide coverage for a family. Dental Savings Plans Are An Easy, Low-Cost Alternative To Dental Insurance According to survey research by the USDA, self-employed workers were twice as likely as employees to be completely uninsured, with approximately one in five self-employed workers going without health insurance. Approximately 84% of people without health insurance also don’t have dental coverage. Another 50% of self-employed workers were covered by a family member’s employer-sponsored plan or by taking on a second job from an employer who offered health insurance to avoid paying the high premiums for an individual plan. Though a potentially steep financial burden has pushed many freelance and contract workers to the risky decision to skip or scale back insurance coverage, it’s important to know that insurance and no insurance are not your only options. One way to keep those costs under control is with a dental savings plan. Regardless of your insurance status, signing up for a dental savings plan on DentalPlans.com can save you an average of 50%* on your dental care. After signing up, simply show your membership card to any participating dentist, and you’ll be charged the discounted rates included in your plan. Dental savings plans provide savings on virtually all dental procedures, have no annual limits, no restrictions on who can sign up or when and activate in as little as one to three days. Visit DentalPlans.com to find tools that help you choose the best plan for your unique needs. Filter plans by dentist, location and procedures and get a personalized dental plan recommendation right away. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. *Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location, and plan. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

August 18, 2023 09:00 AM Eastern Daylight Time

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Spectral MD takes steps toward Rosecliff Acquisition Corp merger

Spectral MD Holdings Ltd

Spectral MD Holdings' general counsel Vince Capone joins Steve Darling on Proactive to provide insights into the latest developments at the company. Capone highlighted the significance of Rosecliff Acquisition Corp's filing of Form 424, a crucial step in Spectral MD's ongoing journey. This filing is triggered by the effectiveness of the RS-4 with Rosecliff, signifying an upcoming shareholder meeting to approve the transaction. The merger aims to reshape Spectral MD into a holding company under Rosecliff, adopting the new name "Spectral AI." This transformation also involves a NASDAQ ticker change from "CLF" to "MD AI." Capone underlined a significant milestone – the successful clearance of the SEC examiner's review, which is pivotal for the transaction. He noted the accelerated timeline for this process compared to the typical three to four months, indicating the company's agile approach. The timeline for further progress is set for September 8, targeting the NASDAQ listing, and the company's exit from other markets. With shareholder meetings for both Spectral MD and Rosecliff scheduled for August 31 and September 6 respectively, the rapid pace of developments is evident. Capone expressed his enthusiasm for the exciting journey ahead, recognizing the dedicated efforts of the team. The transformation promises to be a substantial stride for Spectral MD, and the interview concluded with anticipations for the upcoming listing and more updates. Contact Details Proactive USA +1 604-688-8158 na-editorial@proactiveinvestors.com

August 17, 2023 12:51 PM Eastern Daylight Time

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PathAI Announces Commercial Availability of AISight™ Digital Pathology Image Management System to Power the Next Generation of Pathology Labs

PathAI

PathAI, a global leader in AI-powered pathology, today announced the commercial launch of its AISight TM digital pathology image management system (IMS) for anatomic pathology laboratories. 1 The launch comes at a time when the pathology space is increasingly transitioning to digitally-enabled reads and recognizing the utility of AI and machine learning to enhance quality control, standardize diagnoses, and quantitate biomarkers. AISight is a cloud-based platform that enables efficient, end-to-end digital pathology workflows. AISight provides best-in-class image and case management, ingestion, and viewing while seamlessly enabling access and deployment of AI applications. AISight can also be integrated bidirectionally with laboratory information systems for streamlined workflow adoption. Anatomic pathology laboratories of all sizes and specialties – including health systems, reference laboratories, independent pathology labs, and academic medical centers – may utilize AISight. 1 “We are thrilled to make the AISight Image Management System available to labs globally. We’ve been honing this platform with input from hundreds of pathologists from dozens of institutions, and this launch underpins all of the work PathAI does to support pathologists, biopharma partners, and the academic research community,” said Dr. Andy Beck, M.D. Ph.D., chief executive officer and co-founder of PathAI. “Expanding the feature set to support pathology workflows as an IMS for anatomic pathologist laboratories is a natural progression for PathAI as we strive to meet our mission of improving patient outcomes with AI-powered pathology.” This announcement builds on prior progress as PathAI’s solutions increasingly support digital pathology workflows. In March of this year, PathAI announced the Early Access Program for AISight, and the 12 leading anatomic pathology laboratories that began trialing the platform. Subsequently, PathAI announced the availability of its first 5 algorithm products through the platform including AIM-PD-L1 algorithms across 4 indications, and the AIM-HER2 Breast Cancer algorithm. 2 In addition to AISight for research use, PathAI also has a regulated platform, AISight™ Dx, that has 510(k) clearance for primary digital diagnosis in the US and is CE-marked in the EU. “We have been overwhelmed with the positive feedback from pathologists, lab directors, operators, and administrators who have trialed AISight and we’re excited to make it available at scale,” said Eric Walk, M.D., F.C.A.P., chief medical officer at PathAI. “AISight provides a one-stop shop for digital pathology case management that is flexible for multiple use cases given its interoperability and configurability. We will continue iterating on new and improved features as we listen to our users and release updates as they become available.” To learn more about AISight IMS, register for our upcoming webinar, visit our website, or meet with our team at upcoming conferences including ECP, CAP, and PathVisions. 1 AISight™ is for research use only. Not for clinical use in diagnostic procedures. 2 AIM-PD-L1™ and AIM-HER2™are research use only. Not for clinical use in diagnostic procedures. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 17, 2023 10:00 AM Eastern Daylight Time

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G MEDICAL INNOVATIONS WILL PROVIDE SERVICES TO VETERANS AND MILITARY PERSONNEL BY PARTNERING WITH RESILIENT SUPPORT SERVICES

G-Medical Innovations Holdings Ltd

Rehovot, Israel, August 17 th, 2023 – G Medical Innovations Holdings Ltd. (Nasdaq: GMVD) (“G Medical Innovations”), an industry innovator in comprehensive remote patient monitoring solutions, today announced that its wholly-owned subsidiary, G Medical Innovations USA, Inc., has entered into an agreement with Resilient Support Services Inc. (“RSS”) to expand the health care and remote patient monitoring capabilities to U.S. veterans and military personnel. RSS is a Service-Disabled Veteran-Owned Business that partners with U.S. federal agencies and private sector businesses that are concerned with improving the medical care of veterans and the military community. G Medical Innovations’ innovative technology will help federal agencies and military personnel to better monitor and diagnose new onset cardiovascular symptoms as part of a growing need in virtual care. This will allow full access to near real-time patient information which will also be analyzed by certified cardiac monitoring technicians through G Medical Innovations’ own independent diagnostic testing facility. Available to both adult and pediatric patients, this cloud-based monitoring system includes a small, water-resistant monitor that patients will receive by mail or in person. Patient’s symptoms can then be monitored in near real-time from the comfort of their home. Those who experience unusual arrhythmias or other monitored symptoms receive immediate communication from providers, enabling greater access to care and, in some cases, earlier diagnoses of serious medical conditions. The use of the G Medical Prizma device will allow for state-of-the-art remote patient monitoring (RPM) in the comfort of their home. This care experience platform ensures that patients remain connected with their care teams through next-generation devices to improve clinical decision-making. The patients will be able to download the G Medical app and receive a digital health kit to measure biometric data in one single device. “We are excited to have G Medical Innovations provide their powerful technology and 31 test kits to those serving our country in veteran affairs and all military branches here and abroad. Innovations like this will help protect and improve the care of our veterans and military serving soldiers, now and into the future,” explained Robert Domenici, Lieutenant Colonel (USA Ret.) President and CEO, RSS Inc. “We are delighted to say that we could not find a better partner to serve veterans affairs and all military branches than RSS Inc. G Medical is committed to providing the highest level of care and service to our veterans and military personnel,” said Dr. Yacov Geva, Chief Executive Officer and Founder of G Medical Innovations. About G Medical Innovations G Medical Innovations is a healthcare company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both healthcare providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. For more information about G Medical innovations, visit https://gmedinnovations.com/. About Resilient Support Services Resilient Support Services Inc. (RSS Inc.) is an experienced multi-faceted certified service-disabled veteran-owned business providing strategic advisory services to companies looking to navigate, identify and capitalize on the vast procurement complexities and opportunities within the federal, state, local government and the commercial sectors. The company has a wide-array of health/safety, defense, industrial supply and construction products and service offerings available to its government and commercial clients within the US and abroad. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses the services and products to be provided by the Company to Resilient Support Services Inc and the potential benefits of G Medical Innovations’ technology and specifically the G Medical Prizma device to end users. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Investor Relations Contact G Medical Innovations service@gmedinnovations.com G Medical Innovations Holdings Ltd. is a health care company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both health care providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses: revenue growth and profitability in future periods; the launch of the Company’s CLIA lab in Austin, TX, the Company’s online store for its Prizma Monitoring Devices on Amazon Marketplace and the Company’s HTKs business and online stores; potential announcements with large homecare service companies and large distributors for devices and At Home Test Kits; and the Company’s plans to expand its line of monitoring products and services offered to patients, hospitals and clinics. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties,, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Contact Details G Medical Innovations G Medical Innovations +972 8-958-4777 service@gmedinnovations.com Company Website https://gmedinnovations.com

August 17, 2023 06:00 AM Eastern Daylight Time

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The Mothers’ Milk Bank Welcomes New CEO to Advance the Organization’s Mission to Enhance the Availability and Use of Safe Donor Human Milk for All Babies

Mothers' Milk Bank

The Mothers’ Milk Bank (MMB ), a California-based nonprofit and a leading provider of certified, safe, pasteurized donor human milk to all babies, today announced the appointment of Jennifer Benito-Kowalski as the organization's new Chief Executive Officer. With extensive experience in the nonprofit sector and a genuine passion for the organization's mission, Benito-Kowalski brings a wealth of knowledge and leadership to MMB. As the CEO, Benito-Kowalski will work to expand awareness and bolster support for MMB's mission within the postnatal community and beyond, as the organization prepares to mark its 50th anniversary in 2024. Founded in 1974, Mothers’ Milk Bank is the oldest nonprofit operating milk bank in North America, serving the state of California and other states in the U.S., including Hawaii and Alaska. The Milk Bank distributes safe donor human milk to more than 80% of California's NICUs and other hospitals. The Milk bank is a charter member of the Human Milk Banking Association of North America (HMBANA). Milk banks affiliated with HMBANA are certified safe and have a substantial legacy of meeting the needs of all vulnerable babies. The Milk Bank distributes more than 900,000 ounces of human milk to hospitals and outpatient families across the U.S. "I am both honored and excited to join Mothers’ Milk Bank as CEO," said Benito-Kowalski. "This organization has an incredible legacy of providing life-saving nutrition to infants and supporting families during their most vulnerable moments. I am committed to building upon this strong foundation and working collaboratively with MMB’s dedicated team to expand our reach, deepen our impact, and ensure that every baby has access to the vital nutrition they need to thrive." The Board of Directors of the Mother’s Milk Bank selected Benito-Kowalski from a broad field of candidates to lead the organization into a new era of growth and innovation. With her visionary leadership and passion for making a difference, Benito-Kowalski will address the organization’s strategic goals, which include increasing donor outreach and expanding community partnerships to serve more babies and their families. "We are thrilled to welcome Jennifer Benito-Kowalski as our new CEO," said Katie Anderson, chair of the MMB Board of Directors "Jennifer’s extensive experience, passion, and proven leadership make her the ideal candidate to bring MMB to the next level. Under her direction, we are poised for a promising future providing more life-saving nutrition to infants and supporting families to thrive." For more information about Mother’s Milk Bank, its services, or how to support its mission, please visit MothersMilk.org About The Mothers’ Milk Bank The Mothers’ Milk Bank is a leading nonprofit organization based in San Jose, California, dedicated to providing certified, donated human milk to all babies. The organization collects, pasteurizes, and distributes safe human milk to hospitals and families in need, ensuring that infants receive the essential nutrition required for optimal health and development. With a commitment to improving the lives of babies, Mothers’ Milk Bank plays a vital role in supporting families and advancing neonatal care across California and beyond. Contact Details Mothers' Milk Bank Angelica Rojas +1 831-800-5358 angelica.rojas@mothersmilk.org Company Website https://www.mothersmilk.org

August 16, 2023 11:00 AM Pacific Daylight Time

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Tiziana Life Sciences gets FDA green light to investigate potential Alzheimer's treatment

Tiziana Life Sciences PLC

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chief medical officer and chief operating officer Matthew Davis speaks to Thomas Warner from Proactive after announcing that Tiziana has received FDA clearance to investigate Foralumab as a potential treatment for Alzheimer's disease. Davis says that the news marks a significant milestone for both the company and for Alzheimer's treatment at large, going on to say that the drug will be assessed for efficacy in patients with existing FDA approvals and as a standalone therapy for mild to moderate Alzheimer's cases. The green light from the FDA comes after extensive groundwork, building on the success of Tiziana's work in multiple sclerosis. Davis highlights the wealth of patient safety data and preclinical evidence that bolstered the FDA's decision. Promising preclinical models indicated behavioural improvements in test animals. With the regulatory hurdle crossed, clinical trials are set to commence in collaboration with Brigham and Women's Hospital. Davis acknowledges the vast potential of the Alzheimer's market, which remains underserved. He emphasises the unique approach of Foralumab as the only fully human anti-CD3, which sets it apart from existing treatments. While precise timelines haven't been disclosed, Davis anticipates concrete developments within the next two quarters. He also assures audiences of Tiziana's continued commitment to multiple sclerosis research, with an investigator meeting and dosing of the first patient anticipated by year-end. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:28 AM Eastern Daylight Time

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Roquefort Therapeutics seeks to lock in future value with anti-cancer therapeutic patents

Roquefort Therapeutics PLC

Roquefort Therapeutics PLC (LSE:ROQ, OTCQB:ROQAF) chief executive Ajan Reginald speaks to Thomas Warner from Proactive after announcing the successful filing of a global patent for its anti-cancer therapeutics. Once approved, the international phase PCT (patent treaty cooperation) patent would cover the invention of Roquefort’s RNA oligonucleotide and mRNA therapeutics in over 155 countries, the company said in a statement. Reginald highlights the significant strides made recently by the likes of Moderna, BioNTech, and Merck in employing mRNA effectively against cancer. Roquefort's own promising results were unveiled in June, demonstrating what Reginald calls the cancer-killing potential of their mRNA and RNA oligonucleotide therapies for breast and liver cancers. The global patent covers their proprietary composition, securing their position in a competitive landscape. Reginald emphasises the importance of capturing value through patents, with a view to making the company's offerings enticing for potential partnerships or acquisitions. He explains that "by patenting [the treatments] we're making sure we own that future potential once its realised." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:03 AM Eastern Daylight Time

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