DUBLIN – With the clock ticking on the April 30 PDUFA date for its Contepo (fosfomycin) NDA, Nabriva Therapeutics plc disclosed late Tuesday that the FDA had slapped a complete response letter (CRL) on the file, citing manufacturing deficiencies at one of its contract manufacturers. The Dublin-based antibiotic developer stressed that the agency was not seeking any additional clinical data and had not raised any new safety concerns about fosfomycin, but investors were less than impressed with the inevitable delay to a U.S. launch of the drug, which is in development for treating complicated urinary tract infection (cUTI). Shares in Nabriva (NASDAQ:NBRV) plunged by as much as 42.5% during premarket trading Wednesday before closing down 27.4% at $2.17.