Based on feedback from the FDA and the receipt of the minutes from its meeting with the agency, Nabriva Therapeutics (NASDAQ:NBRV) expects to resubmit its marketing application next quarter for CONTEPO (fosfomycin) for the treatment of complicated urinary tract infections, including acute pyelonephritis.
The company received a CRL in April citing deficiencies at one of its contract manufacturers.
Shares are up 4% premarket on light volume.
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