|From: burp (Rep: 73)||Date: 01/14/2019 07:16|
|Forum: Nabriva Therapeutics AG - Msg #109||Thread #674057430 (Rec: 0) |
|PDUFA Moved up to April30 from June 30...Looks like 99% approval likely! |
DUBLIN, Ireland, Jan. 14, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has updated the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the CONTEPO New Drug Application (NDA) from June 30, 2019 to April 30, 2019. The two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the CONTEPO NDA submitted in October 2018. In addition to priority review, CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.
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