Edison Investment Research - Bioporto A/S (BIOPOR) BioPorto Diagnostics - FDA â€“ more data needed for paediatric AKI

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Edison Investment Research

Sean Conroy

BioPorto Diagnostics - FDA â€“ more data needed for paediatric AKI

Following an interaction with the FDA, BioPorto announced on 18 November 2019 that it will need to gather more data to complete the 510(k) application for the paediatric NGAL Test. The company expects this process to take several months and to resubmit its application in Q220. The feedback from the FDA has implications relating to the ongoing adult NGAL study, which is now expected to be submitted after the paediatric application (pushed back from Q419).

02/12/2019 5 EN

Underlying

Bioporto A/S

Bioporto A/S is a Denmark-based company engaged in the development and marketing of in vitro diagnostic (IVD) assays. The Company's portfolio comprises five product categories: The Neutrophil gelatinase-associated lipocalin (NGAL) Test, which is a test for diagnosing acute kidney injury; NGAL Enzyme-linked immunosorbent assay (ELISA) kits, which supplies NGAL for the development of medicines for estimating side-effects that are harmful to kidneys; Mannan-binding Lectin (MBL) ELISA kit, which offers monoclonal MBL antibodies that are responsible for the activation of immune response; Antibodies, including monoclonal antibodies used in a range of research areas, such as microbiology, biomarkers, peptide hormones and plasma proteins; and Activated Protein C with Protein C Inhibitor Complex (APC-PCI), a biomarker applied to patients with sepsis and thrombotic and hemostatic disorders. In addition, the Company is a parent of BioPorto Diagnostics A/S.

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DK0011048619 Nasdaq Nordic Copenhagen Denmark

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

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BioPorto Diagnostics - FDA â€“ more data needed for paediatric AKI

Grant of warrants

BioPorto A/S Appoints Chief Legal Officer

New Board Candidate for the upcoming Annual Geneal Meeting

AGBA - A transformational deal

Biodexa Pharmaceuticals - In a period of transition

Norcros - Sale of Johnson Tiles UK agreed

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