 Nabriva Therapeutics plc NBRV, a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that it received a Complete Response Letter CRL from the U.S. Food and Drug Administration FDA for the New Drug Application NDA resubmission seeking marketing approval of CONTEPO fosfomycin for injection for the treatment of complicated urinary tract infections cUTI, including acute pyelonephritis. Although Nabrivas European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDAs inability to conduct onsite inspections because of travel restrictions. 