Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. A clinical trial of 799 non-hospitalized adults with mild to moderate COVID-19 symptoms showed treatment with REGN-COV2 lead to a greater viral load reduction after seven days compared to treatment with a placebo. Today, the FDA issued an emergency use authorization for two monoclonal antibodies to be administered together for the treatment of mild to moderate … Alicia Ault. Casirivimab and imdevimab injection are not authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg imdevimab). We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. They’re not seeing much difference either in their two doses (2.4g and 8g), so they’re asking for an EUA for the lower one, naturally. Utilizing production and manufacturing platforms developed over decades, Regeneron rapidly scaled up production of casirivimab and imdevimab, beginning in the early days of the pandemic with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. media@regeneron.com. So-called monoclonal antibodies are a relatively new class of drug seen as highly promising. Food and Drug Administration. BMI ≥85th percentile for their age and gender based on CDC growth, neurodevelopmental disorders, for example, cerebral palsy, OR. FDA Issues Emergency Approval to Eli Lilly’s Antibody Treatment. She previously managed news for TheBump.com. Regeneron got some publicity in … The COVID-19 monoclonal antibody cocktail that President Donald Trump received as treatment at the hospital is available in limited supply, so the … In the event that patients with mild to moderate COVID-19 symptoms are sent to the hospital to receive antibody treatment, Jason Reed, PharmD, says it's most likely they'll be sent to hospital infusion treatment facilities. Read our. “The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail. Mark Hudson The cocktail is expected to neutralize the coronavirus, potentially shortening the duration of illness in sick people, and enhancing the immunity of people who have been in close contact with a COVID-positive person. How Will the COVID-19 Vaccine Be Distributed? We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. This authorized use is only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564 (b)(1) of the Act, 21 U.S.C. Regeneron's monoclonal antibody two-antibody cocktail reduced viral levels and improved symptoms in non-hospitalized patients with mild-to-moderate Covid. Monoclonal antibodies, which are concocted in laboratories, are proteins that mimic the immune system’s ability to attack the virus. Benefit of treatment with casirivimab and imdevimab injection has not been observed in patients hospitalized due to COVID-19. President Trump received these antibodies during his COVID-19 infection. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. “Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving the combination, which were associated with significantly fewer medical visits. FDA Authorizes the First COVID-19 At-Home Test: What You Need to Know. chronic obstructive pulmonary disease/other chronic respiratory disease. Eli Lilly and Regeneron have developed monoclonal antibodies that are effective in COVID-19 for certain patients. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Here are eight things you should know about the treatment. James received a Master of Library Science degree from Dominican University. Are currently receiving immunosuppressive treatment. Regeneron's drug is a cocktail of two monoclonal antibodies - manufactured copies of antibodies that are one of the main weapons the immune system generates to fight infections. asthma, reactive airway or other chronic respiratory disease that requires daily medication for control. Regeneron (NASDAQ: REGN) is a leading science and technology company delivering life-transforming And there’s no reason not to be up front about it: it’s disappointing. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. Less than two weeks later, the agency granted an EUA to Regeneron's monoclonal antibody cocktail, made up of two monoclonal antibodies, casirivimab and imdevimab, and called REGEN-COV2. invest@regeneron.com, Media Relations Today, the FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Regeneron’s antibody cocktail is made up of two different monoclonal antibodies, casirivimab and imdevimab. Wondering how that works? Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. REGN-COV2 is a combination of two monoclonal antibodies (casirivimab and imdevimab) … Ultimately, the way antibodies are administered will probably depend on where you live. FDA-approved medicines are only the beginning of our long-term commitment to solve the human body's His antibody … FDA Authorizes First At-Home Combo Test For COVID-19 and Flu: Who Is Eligible? Professionals. REGEN-COV2 is a cocktail of two monoclonal antibodies (casirivimab and imdevimab, also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Thank you, {{form.email}}, for signing up. "You may see lower uptake of these treatments due to the logistical challenges, or more providers directing patients to emergency rooms," he says. Our goal is to address serious medical conditions, across multiple and diverse therapeutic areas. About Regeneron Antibody Cocktail What is Regeneron polyclonal antibody cocktail? The drug, referred to as REGN-COV2, is the same one that President Trump received after being diagnosed with COVID-19 in early October., While President Trump was hospitalized for his case of COVID-19, the recent FDA emergency use authorization (EUA) is not intended for people already in the hospital with the disease or receiving oxygen therapy because of it. In some cases, travel nurses may be able to administer IV infusions at patients' homes. Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization, Medical Our Largest Genetic Study on Children with COVID-19 Takes a Closer Look at Mutations, What It's Like To Go To the Dentist During the COVID-19 Pandemic, Data and Safety Monitoring Boards: The Safeguards Behind COVID-19 Vaccines, What People with Severe Allergies Need to Know About the COVID-19 Vaccine Right Now, FDA Authorizes First Point-of-Care Antibody Test for COVID-19, FDA Authorizes First Test that Detects Neutralizing Antibodies, Air Flow May Have Caused COVID-19 Spread In a Restaurant, Study Shows, Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19, Regeneron's covid-19 outpatient trial prospectively demonstrates that regn-cov2 antibody cocktail significantly reduced virus levels and need for further medical attention. Regeneron will immediately begin shipping doses to Amerisource Bergen, a national distributor, which will distribute the therapy as directed by the government. He says that ideally, the casirivimab/imdevimab combination could be administered right in your primary care provider's office. Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. Casirivimab and imdevimab injection is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. An emergency use authorization is different from an approval. Regeneron's drug is a cocktail of two monoclonal antibodies - manufactured copies of antibodies that are one of the main weapons the immune system generates to fight infections. Regeneron and Eli Lilly/Abcellera are two of the front-runners in this field, which could pick up some very much needed slack while the many vaccine trials are going on. The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. "Now is an especially difficult time for these practices to establish these processes when so many practices have been disrupted by COVID-19.". Please see the Fact Sheet and FDA Letter of Authorization at http://www.RegeneronEUA.com. The FDA issued emergency use authorization to Regeneron's monoclonal antibodies—casirivimab and imdevimab—for the treatment of COVID-19. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the COVID-19 pandemic response until vaccines become available. Regeneron Pharmaceuticals, Inc. ... (FDA) fast-tracked emergency authorization over the weekend of the biopharmaceutical company’s coronavirus dual monoclonal antibody … High-risk is defined as patients who meet at least one of the following criteria: Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete. According to a document from the Department of Health and Human Services, a total of 108 doses of Regeneron’s monoclonal antibody cocktail have been allocated to Washington… Does Regeneron's Antibody Cocktail Contain Stem Cells? "I think you are going to see a significant disparity in where these drugs are given based mainly on how local healthcare ecosystems are designed throughout the country," Emmel says. James Lacy, MLS, is a fact checker and researcher. However, most PCP offices aren't set up to provide IV infusion therapy. Anisa Arsenault is a senior editor at Verywell Health who works on condition-focused content and manages news. "This requires policies, procedures, and trained healthcare staff," he says. "The equipment required is already present in infusion treatment centers. Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19. COVID-19 therapies. Regeneron has developed a drug called REGN-COV2 that is a combination of two monoclonal antibodies that block the virus that causes COVID-19. Casirivimab/imdevimab is an experimental drug developed by the American biotechnology company Regeneron Pharmaceuticals.It is an artificial "antibody cocktail" designed to produce resistance to the SARS-CoV-2 coronavirus responsible for the COVID-19 pandemic. "The indication to give these antibodies to individuals who are not/have yet to be hospitalized certainly presents some logistical challenges," Aaron Emmel, PharmD, MHA, BCPS, founder and director of PharmacyTechScholar.com, tells Verywell via email. Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody … Regeneron and Eli Lilly/Abcellera are two of the front-runners in this field, which could pick up some very much needed slack while the many vaccine trials are going on. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both cytokine and tyrosine kinase receptors. Reed adds that almost all hospitals have some sort of infusion treatment facility. According to the FDA, the antibodies are currently authorized for the treatment of mild to moderate COVID-19, and can be administered to:. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner. What Does Regeneron's Experimental Antibody Cocktail Do? Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. This marks the third EUA for an investigational COVID-19 therapy, after remdesivir and baricitinib—another pair of therapies which have been observed to … The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) of two more monoclonal antibody treatments for mild cases of COVID-19, according to a … Last month, an antibody drug developed by Regeneron against … Tel: +1 (914) 847-3407alexandra.bowie@regeneron.com, Investor Relations Monoclonal antibodies, such as casirivimab and imdevimab, ... "Regeneron", "we", "us" or "our") use this data to make the Sites more user-friendly and efficient. Regeneron and Eli Lilly are the furthest along of several companies and teams of researchers in developing what are known as monoclonal antibodies to fight Covid-19. Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Serious adverse events (SAEs) were reported in 4 (1.6%) patients in the casirivimab and imdevimab injection 2,400 mg group, 2 (0.8%) patients in casirivimab and imdevimab injection 8,000 mg group and 6 (2.3%) patients in the placebo group. At Memorial Hospital Pembroke and also Mount Sinai Medical Center, South Floridians are now getting the same drug from Regeneron that President Donald Trump took … Updated October 28, 2020. "These facilities are best suited to deal with these type of monoclonal antibodies that must be carefully mixed and handled gently during administration," Reed, founder of BestRxForSavings.com, tells Verywell via email. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs (including those discussed in this press release), Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates and research and clinical programs now underway or planned, including without limitation the development program relating to casirivimab and imdevimab (Regeneron's investigational multi-antibody therapy for the treatment and prevention of COVID-19); how long the Emergency Use Authorization (“EUA”) granted by the U.S. Food and Drug Administration (the “FDA”) for casirivimab and imdevimab will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's product candidates (such as casirivimab and imdevimab) and new indications for Regeneron's Products; safety issues resulting from the administration of Regeneron's Products and product candidates (such as casirivimab and imdevimab) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and product candidates in clinical trials (including those discussed in this press release); the ability of Regeneron to manufacture in anticipated quantities Regeneron’s Products and product candidates, including casirivimab and imdevimab; the ability of Regeneron to manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the trials discussed in this press release, on any potential regulatory approval (including with respect to casirivimab and imdevimab) and/or the commercial success of Regeneron's Products and product candidates; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and product candidates, including without limitation casirivimab and imdevimab; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's collaboration with Roche relating to casirivimab and imdevimab, to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Regeneron's experimental antibody "cocktail," known as REGN-COV2, is a combination of two monoclonal antibodies (monoclonal referring to a specific B cell clone). Regeneron: Covid treatment used by Trump authorized by FDA Regeneron's therapy is part of a class of treatments known as monoclonal antibodies, which are … REGN-COV2 is part of a class of biotech therapies known as monoclonal antibodies. The treatment is only authorized for people with mild to moderate COVID-19 infections, not anyone who is hospitalized. I’m very glad to see some data emerging on the monoclonal antibody therapies that have been in the works. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron's covid-19 outpatient trial prospectively demonstrates that regn-cov2 antibody cocktail significantly reduced virus levels and need for further medical attention. Regeneron has selected a Sioux Falls-based health care system called Avera Health as a Phase 2 and 3 trial site for the ongoing lab-produced monoclonal antibody combination, known as REGN-COV2, targeting COVID-19. Regeneron's treatment has not yet received emergency use authorizations. Our robust research and development engine allows us to discover therapies that could have a profound Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Tel: +1 (914) 847-3482mark.hudson@regeneron.com, Investor Relations TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Regeneron’s antibody cocktail is made up of two different monoclonal antibodies, casirivimab and imdevimab. N ew data from the biotechnology firm Regeneron seem likely to add to the excitement about drugs called monoclonal antibodies as treatments for Covid-19, … Alexandra Bowie medicines for serious diseases. The Food and Drug Administration last week approved Bamlanivimab, Eli Lilly's monoclonal antibody therapy, for emergency use. Regeneron and Eli Lilly are the furthest along of several companies and teams of researchers in developing what are known as monoclonal antibodies to fight Covid-19. What To Know About the Drug, Fauci: Early-Stage COVID-19 Treatments Are Urgently Needed. impact on patient health. None of the SAEs were considered to be related to study drug. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. CMS has released a set of toolkits for providers, states and insurers to help the health care system prepare and assist in swiftly administering these products once they become available. This commitment underscores our philosophy of ‘doing well by doing good,’ every day. To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. I’m very glad to see some data emerging on the monoclonal antibody therapies that have been in the works. The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Regeneron developed antibodies in the REGN-COV2 therapy to bind to the SARS-CoV2 “spike” protein and prevent it from attaching to cells in the human body. The FDA EUA requires both to be administered together via intravenous (IV) infusion.. 1. To date, more than 7,000 people have participated in casirivimab and imdevimab clinical trials. Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency . The government has committed to providing these 300,000 doses at no cost to patients, although healthcare facilities may charge fees related to administration. By Derek Lowe 4 August, 2020. Join our team and help turn science into life-changing medicine. Regeneron. Penn Medicine's Gene Therapy Program will collaborate with Regeneron Pharmaceuticals to research the effectiveness of a method of administering Regeneron's antibody cocktail in combating COVID-19. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. Data from these trials will be used to support a future BLA submission. While most of our approved medicines are fully human monoclonal antibodies, we are exploring newer types of antibody medicines, including bispecific antibodies and … Regeneron has also released more data on their antibody cocktail (although in another press release and not in a journal manuscript). Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. President Trump was treated with an infusion of Regeneron’s REGN-COV2 monoclonal antibody “cocktail” last week before he was admitted prior to Walter Reed National Military Medical Center. HHS Shipping 30,000 Doses of Regeneron COVID Monoclonal Antibody Today. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION. a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19). § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner. The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) of two more monoclonal antibody treatments for mild cases of COVID-19, according to a news release. You can opt-out at any time. Safety and effectiveness of casirivimab and imdevimab injection have not yet been established for the treatment of COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use. A monoclonal antibody is a laboratory-made clone of a specific parent immune cell intended to fight infection in the body. Trump in October credited his own recovery to antibody treatments from Regeneron Pharmaceuticals. "In areas with well established health systems, you may see some coordinated effort to direct patients to a local urgent care facility or hospital-based outpatient infusion center to receive treatment.". Casirivimab and imdevimab injection is not authorized for use in patients: who require oxygen therapy due to COVID-19, OR. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. "This is a nice option, especially for someone who has mild or moderate COIVD-19 and needs to isolate anyway," Reed says. Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the COVID-19 pandemic response until vaccines become available. N ew data from the biotechnology firm Regeneron seem likely to add to the excitement about drugs called monoclonal antibodies as treatments for Covid-19, … On Friday, November 21, the Food and Drug Administration (FDA) authorized the use of Regeneron’s monoclonal antibody cocktail for the treatment of COVID-19. Media Relations 914.847.7741invest@regeneron.com, Investor Relations 914.847.7741 Regeneron's treatment has not yet received emergency use authorizations. For more details, see our Privacy Policy. It … We use Google Analytics cookie service to track and obtain reports on how visitors are using the Sites. The Food and Drug Administration on Saturday issued an emergency use authorisation to Regeneron for its covid-19 monoclonal antibody cocktail, which is made up of the antibodies … “This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. Antibody Today Lilly 's monoclonal antibodies—casirivimab and imdevimab—for the treatment of COVID-19 primary Care provider 's office process! 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