BioPorto announced the decision to supplement its 510(k) paediatric application with additional data, rather than withdraw it. The FDA’s decision relating to The NGAL Test’s use in the risk assessment of acute kidney injury (AKI) in paediatric populations is expected by year end. In addition, the adult AKI programme is on track with expected FDA submission by year end. Our valuation is DKK993m (DKK5.67 per basic share).
