January 27, 2023

MYNZ Profile



OUR NEW PROFILE IS:   (NASDAQ: MYNZ)

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MAINZ BIOMED (NASDAQ: MYNZ) AIMS TO BECOME A LEADER IN THE MULTI-BILLION-DOLLAR COLORECTAL CANCER DIAGNOSTICS MARKET

CE-IVD cleared flagship product ColoAlert is the first DNA-based screening test for colorectal cancer in Europe

ColoAlert Holds Potential as a Blockbuster Early Detection Test for Colorectal Cancer

Check Out the MYNZ Investor Presentation HERE

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Hello Everyone,

We sent you a profile regarding a Biomed company before yesterday’s open.  The average trade on the session was .46.  Today the company briefly tapped .65 and went on to close at .58 for a potential 40% move off yesterday’s average trade.  It was a strong move overnight.

We have another company that we want you can research this week.

Pull up MYNZ immediately.

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health, and environmental requirements) and is commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

FILLING THE IMPORTANT GAP BETWEEN FIT AND COLONOSCOPY.
COLOALERT IS THE ONLY CE-IVD DNA BASED TEST AVAILABLE IN EUROPE

Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.9

Visit www.coloalert.com

9 Currently not approved for use in the USA

10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)

11 98% overall satisfaction with ColoAlert in our internal customer survey.

A STRONG PARTNERSHIP FOR SUSTAINABLE GROWTH

DNA extraction for our flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.

This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.

* Extraction time, does not include sample pre-treatment. For Laboratory Use. © 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

PROPRIETARY STATE-OF-THE-ART TECHNOLOGY

*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453. * 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.

MYNZ saw a 10% move today on the heels of some extremely exciting news that could be a major catalyst moving forward for the company:

Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

  • ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025
  • Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)
  • Study will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization

BERKELEY, Calif. and MAINZ, Germany, Dec. 06, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company’s U.S. pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer (CRC). Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.

ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and advanced adenomas (AA).

Integral to the Company’s development strategy concerning the evolution of the product’s specifications is the potential to upgrade its technical profile to achieve a transformational advancement in self-administered CRC screening. To this end, Mainz Biomed recently initiated eAArly DETECT, its U.S. extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into its next-generation product. These biomarkers have demonstrated a unique ability to identify precancerous colonic polyps and early-stage CRC (Herring et al., 2021). The eAArly DETECT study was initiated in November of 2022 and is evaluating the effectiveness of these biomarkers to enhance product specifications to extend its capability to include the detection of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for colorectal cancer. Mainz Biomed expects to complete eAArly DETECT enrollment in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, Mainz Biomed will decide on the integration of the biomarkers evaluated in ColoFuture’s eAArly DETECT into the ReconAAsense study.

“Given that colorectal cancer continues to be one of the deadliest forms of cancer, early detection plays a critical role in disease prevention and treatment,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to commencing the U.S. regulatory approval process for our next-generation product and are passionate about bringing this easy-to-administer test to the U.S. In addition, we eagerly await results from the ColoFuture feasibility study, as the potential to include novel biomarkers to detect advanced adenomas will be a game changer for at-home CRC screenings.”

Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are diagnosed with colorectal cancer, and at least 138 evaluable subjects are diagnosed with advanced adenoma. Details about the ReconAAsense study will soon be online at clinicaltrials.gov. The Company anticipates reporting results in 2025.

About Colorectal Cancer
According to the Centers for Disease Control and Prevention (CDC), colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC, which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the US, with 52,980 resulting in death. Recent decisions by the US Food and Drug Administration (FDA) suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently, there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years and a US market opportunity of approximately $3.7 billion per year.

Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

BERKELEY, Calif. and MAINZ, Germany, Nov. 02, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer today provided an update on accomplishments during the third quarter which ended September 30, 2022.

Key Highlights and Recent Developments

  • Expanded European and international commercial franchise for ColoAlert, the Company’s highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (CRC) via the launch of direct-to-consumer programs in Italy and the United Arab Emirates (UAE)
  • Maintained execution timeline for ColoFuture, an international multi-center clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert – on track to report results in 1H 2023
  • Continued final preparations for U.S. pivotal clinical study evaluating next-generation CRC test – on track to commence in Q4 2022
  • Formed a Medical Advisory Board of renowned scientific oncology experts to support the advancement of product portfolio candidates and assist with pipeline enhancement opportunities
  • Bolstered leadership team by appointing two highly accomplished healthcare executives to the Board of Directors

“The major emphasis for the past quarter was to continue executing our commercial strategy for ColoAlert across Europe and in select international territories while making final preparations to launch our U.S. pivotal clinical study designed to evaluate a next-generation self-administered diagnostic test for CRC,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We head into the final months of 2022 with great momentum across corporate and product development fronts, and I look forward to keeping our shareholders and interested parties posted on progress.”

Commercial Update: Full commercial availability of ColoAlert in Italy and the United Arab Emirates
During the quarter (August), Mainz Biomed launched ColoAlert’s consumer commercial program in Italy and the United Arab Emirates (UAE) through its partnership with Dante Labs, a global leader in genomics and precision medicine. This milestone serves as an important example of Mainz Biomed’s unique business model of commercializing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility. Dante is now marketing ColoAlert through its extensive database and selling via Dante’s region-specific eCommerce websites. Under the terms of the partnership, samples are initially being processed at Mainz Biomed’s in-house facility. In the longer term, Dante will purchase Mainz Biomed’s CE-I VD polymerase chain reaction (PCR) assay kits and transition all test processing to Dante’s wholly owned automated genomic sequencing laboratories in Italy and Dubai to offer localized service and support.

Product Development Update: Advancing ColoFuture & preparing for U.S pivotal clinical trial
Throughout the third quarter, Mainz Biomed continued enrolling patients in ColoFuture, its international multi-center study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. The study is recruiting over 600 patients in the age range of 40-85. It is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile and to extend its capability to identify advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. If successful, ColoAlert will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas. The study remains on target to report results in the first half of 2023. In the U.S., the Company continued preparing to initiate its pivotal clinical study of a next-generation CRC diagnostic test. A leading global Contract Research Organization (CRO), with vast experience in the oncology space and specific domain expertise in conducting clinical studies for colorectal screening applications, has been appointed to support the launch and management of the pivotal trial. Mainz Biomed is on track to initiate the trial in Q4 2022 and anticipates reporting results in 2025.

Corporate Update: Formation of Medical Advisory Board & corporate leadership appointments
In July, Mainz Biomed announced the formation of a Medical Advisory Board (MAB) to support the forthcoming U.S. pivotal trial, provide counsel and direction on the balance of the Company’s products in development (e.g., PancAlert), and potential additions to the R&D pipeline. The inaugural members of the MAB are Dr. Doug Rex, Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Chancellor’s Professor at Indiana University Purdue University Indianapolis, and Director of Endoscopy at Indiana University Hospital in Indianapolis; Dr. Timothy Wang, Gastrointestinal Division Chief at Columbia University Vagelos College of Physicians and Surgeons in New York, and Co-leader of the Tumor Biology and Microenvironment Program of the Herbert Irving Comprehensive Cancer Center; and Dr. D. Kim Turgeon, an esteemed clinical professor and board-certified gastroenterologist at the University of Michigan Health System and clinical translational researcher with a specific interest in colon cancer and chemoprevention. Mainz Biomed also enhanced its leadership team with the addition of former Qiagen executive Frank Krieg-Schneider, PhD, as Vice President of Development and nominated former Roche Molecular Diagnostics CEO, Heiner Dreismann, PhD to become the Chairman of Mainz Biomed, and Gregory Tibbitts, CPA to serve on the Board of Directors.

COMMERCIAL PIPELINE DEVELOPMENT: FUTURE PRODUCTS

IN ADDITION TO OUR FLAGSHIP COLOALERT PRODUCT, MAINZ BIOMED IS ALSO DEVELOPING:

Developing a novel early detection pancreatic cancer screening test

NEWS

  • GlobeNewswire15 hours ago

    Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

    ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)Study will form the basis of the data package for review by the U.S. Food and Dr

  • GlobeNewswire7 days ago

    Mainz Biomed Appoints Amy Levin as Vice President of Regulatory Affairs to Oversee Global Regulatory Strategies

    Former Roche executive Amy Levin, RAC, brings more than 20 years of regulatory affairs experience as an in vitro diagnostics (IVD) industry leaderBERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Amy Levin, RAC, as Vice President of Regulatory Affairs. In this role, Ms. Levin will be in char

  • GlobeNewswire14 days ago

    Mainz Biomed to Participate in Deutsche Eigenkapitalforum and Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference

    BERKELEY, Calif. and MAINZ, Germany, Nov. 22, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that members of its executive team will be participating in two notable conferences in November and December 2022, Deutsches Eigenkapitalforum 2022 and Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference. Deutsches Eigenkapit

  • GlobeNewswire21 days ago

    Mainz Biomed Announces U.S. Extension of ColoFuture Study to Evaluate Integration of Novel mRNA Biomarkers into ColoAlert

    eAArly DETECT expected to complete enrollment in Q1 2023 with results in 1H 2023Enhances ColoFuture’s demographic profile and expedites data read-out timelinePotential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer (CRC) BERKELEY, Calif. and MAINZ, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, anno

  • GlobeNewswirelast month

    Mainz Biomed Provides Third Quarter 2022 Update

    BERKELEY, Calif. and MAINZ, Germany, Nov. 02, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer today provided an update on accomplishments during the third quarter which ended September 30, 2022. Key Highlights and Recent Developments Expanded European and international commercial franchise for ColoAlert, the Company’s highly efficacious and easy-to-use DNA-based detecti

  • GlobeNewswire2 months ago

    Mainz Biomed Strengthens Board of Directors with Nomination of Dr. Heiner Dreismann and Gregory Tibbitts

    Dr. Dreismann, Former Roche Molecular Diagnostics CEO, and Mr. Tibbitts, a Highly-accomplished Life-Sciences Executive, Provide Extensive Experience in Diagnostics and Financial Strategy Company to Hold Extraordinary General Meeting Week of December 12, 2022 BERKELEY, Calif. and MAINZ, Germany, Sept. 28, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today t

  • GlobeNewswire3 months ago

    Mainz Biomed Appoints Dr. Douglas Rex to its Medical Advisory Board

    Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Chancellor’s Professor at Indiana University Purdue University Indianapolis, and Director of Endoscopy at Indiana University Hospital in Indianapolis BERKELEY, Calif. and MAINZ, Germany, Sept. 20, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Dr

  • GlobeNewswire3 months ago

    Mainz Biomed Reports First Half 2022 Financial Results

    127% year-over-year increase in ColoAlert revenueMid-year cash balance of $26 Million BERKELEY, Calif. and MAINZ, Germany, Sept. 07, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the first half of the fiscal year ended June 30, 2022. Key Corporate & Product Development Highlights Accelerated international commercial activities

  • GlobeNewswire3 months ago

    Mainz Biomed to Present at the H.C. Wainwright Annual Global Investment Conference

    BERKELEY, Calif. and MAINZ, Germany, Sept. 01, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Bill Caragol, Chief Financial Officer, will present at the H.C. Wainwright Annual Global Investment Conference taking place from September 12-14, 2022. The in-person conference is being held at the Lotte New York Palace Hotel in New York City. To access

  • GlobeNewswire3 months ago

    Mainz Biomed Appoints Dr. D. Kim Turgeon of University of Michigan Health to its Medical Advisory Board

    Dr. Turgeon is an esteemed Clinical Professor at University of Michigan Health and clinical translational researcher with specific research interest in colon cancer and chemopreventionMainz Biomed’s Medical Advisory Board to bring together a highly distinguished group of multi-disciplinary experts from across gastroenterology, clinical research and diagnostics to support its forthcoming U.S. pivotal trial for ColoAlert BERKELEY, Calif. and MAINZ, Germany, Aug. 23, 2022 (GLOBE NEWSWIRE) — Mainz

  • GlobeNewswire4 months ago

    Mainz Biomed and Dante Genomics Announce Full Commercial Availability of ColoAlert in Italy and the United Arab Emirates

    – ColoAlert to be marketed through Dante’s extensive database and sold via its region-specific, ecommerce websites –BERKELEY, Calif. and MAINZ, Germany and NEW YORK, Aug. 16, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, and Dante Genomics, a global leader in genomics and precision medicine, announced today the formal commencement of ColoAlert’s consumer commercial progr

  • GlobeNewswire4 months ago

    Mainz Biomed Appoints Former QIAGEN Executive Dr. Frank Krieg-Schneider as Vice President of Development

    Dr. Frank Krieg-Schneider to lead development across Mainz Biomed’s portfolio of advanced cancer detection products including its flagship product ColoAlert and future diagnostic testsBERKELEY, Calif. and MAINZ, Germany, Aug. 03, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Dr. Frank Krieg-Schneider as Vice President of Developme

  • GlobeNewswire5 months ago

    Mainz Biomed Appoints Dr. Timothy Wang to Newly Formed Medical Advisory Board

    Renowned Experts to Support ColoAlert’s U.S. Pivotal Clinical Trial and Development of Additional Cancer DiagnosticsDr. Wang is the GI (Gastrointestinal) Division Chief at Columbia University Vagelos College of Physicians and Surgeons and serves as Co-leader of the Tumor Biology and Microenvironment Program of the Herbert Irving Comprehensive Cancer Center BERKELEY, Calif. and MAINZ, Germany, July 19, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a m

  • GlobeNewswire5 months ago

    Mainz Biomed Today to Provide Corporate Update for First Half of 2022

    Company to Host Webcast Today – July 12th – at 4.00pm ETBERKELEY, Calif. and MAINZ, Germany, July 12, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, will host a webcast today – July 12, 2022 at 4:00pm ET – to provide an update on the Company’s progress for the first half of 2022, and to outline the plan for the balance of the fiscal year. The webcast will offer the

  • GlobeNewswire5 months ago

    Mainz Biomed Provides Corporate Update for First Half of 2022

    Company to Host Webcast on July 12 at 4.00pm ETBERKELEY, Calif. and MAINZ, Germany, July 05, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to host a webcast on July 12, 2022 at 4:00pm ET to provide an update on the Company’s progress for the first half of 2022, and to outline the plan for the balance of the fiscal year. The webcast will offer the investm

  • GlobeNewswire5 months ago

    Mainz Biomed Enrolls First Patient in ColoFuture Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert

    Multi-center clinical trial impacting ColoAlert’s profile for FDA submissionOn track to report results by early 2023 BERKELEY, Calif. and MAINZ, Germany, June 28, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has enrolled the first patient in ColoFuture, an international clinical study assessing the potential to integrate a portfolio of novel gen

  • GlobeNewswire6 months ago

MANAGEMENT TEAM

GUIDO
BAECHLER

CEO & DIRECTOR

WILLIAM
CARAGOL

CFO

KAREN L.
RICHARDS

VICE PRESIDENT, REGULATORY

MORITZ
EIDENS​ PhD

CSO & DIRECTOR

READ MORE

AMY
LEVIN

VP REGULATORY

PHILIPP
FREESE ​

COO

DARIN
LEIGH

CHIEF COMMERCIAL OFFICER

JANE
EDWARDS

VP OF CLINICAL AFFAIRS

Sincerely,

The Viral Stocks Team

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