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Stock impact report

Trevena Announces Receipt of Type A Meeting Minutes and Provides Regulatory Update for Oliceridine

Trevena, Inc. (TRVN) 
Last trevena, inc. earnings: 3/12 07:01 am Check Earnings Report
US:NASDAQ Investor Relations: investors.trevena.com/investor-relations
Company Research Source: GlobeNewswire
– Company announces initial path forward on oliceridine NDA – – Company to host conference call on Monday, January 28 at 8:30 a.m. ET – CHESTERBROOK, Pa., Jan. 28, 2019 (GLOBE NEWSWIRE) --  Trevena, Inc. (NASDAQ: TRVN) today announced the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the oliceridine New Drug Application (NDA). FDA has agreed that the Company’s current safety database will support labeling at a maximum daily dose of 27 mg.     FDA also has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms.  The Company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year.  The Company is not required to provide any additional ef Show less Read more
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