Correvio Pharma Corp. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application. The company also announced certain preliminary financial results for the second quarter ended June 30, 2019. Revenue for the second quarter is expected to be in the range of $7.2 to 7.6 million (USD), which represents an approximately 20% increase compared to the second quarter of 2018, despite 5% weakness in the Euro. As of June 30, 2019, Correvio had cash, cash equivalents and unrestricted cash totaling approximately $12.9 million (USD). The Company will report its full financial results in August. The Brinavess NDA is supported by data from SPECTRUM, a post-authorization safety study that was conducted in Europe which evaluated 1,778 unique patients across a total of 2,009 treatment episodes following administration of Brinavess. The SPECTRUM data demonstrated that treatment with Brinavess successfully converted 70.2% of those treated AF patients into normal sinus rhythm. In addition, treatment with Brinavess showed a median time to conversion of 11 minutes from the start of the first infusion among patients who successfully converted. The cumulative incidence of health outcomes of interest (defined as significant hypotension, ventricular arrhythmia, atrial flutter, or bradycardia) was reported in 0.8% of patients. Twenty-eight serious adverse events were reported in 26 of the 1,778 patients and no deaths were reported in the study. In addition to SPECTRUM, the Brinavess NDA is supported by nine Phase 3 and Phase 2 clinical trials and over eight years of post-marketing experience in approximately 50,000 treatment patients worldwide. Brinavess has received marketing authorizations in 41 countries outside the U.S.