Dec 24 (Reuters) - Correvio Pharma Corp CORV.TO :
* CORREVIO RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FDA FOR BRINAVESS AND PROVIDES UPDATE ON RECENT EVENTS
* CORREVIO PHARMA - CRL STATED THAT FDA DETERMINED IT CANNOT APPROVE BRINAVESS NDA IN ITS PRESENT FORM AND PROVIDED RECOMMENDATIONS NEEDED FOR RESUBMISSION
* CORREVIO PHARMA - FDA ALSO STATED RISK OF SERIOUS CARDIOVASCULAR ADVERSE REACTIONS WILL NEED TO BE MUCH LESS THAN 1% IN SELECTED PATIENT POPULATION
* CORREVIO - IN CRL, FDA STATED THAT SUBMITTED DATA DOES NOT PROVIDE REASSURING EVIDENCE OF BRINAVESS' SAFETY
* CORREVIO PHARMA - INTENDS TO REQUEST MEETING WITH FDA AS SOON AS POSSIBLE TO DISCUSS DESIGN, SPECIFICS OF A POTENTIAL STUDY TO ADDRESS FDA'S CONCERNS
* CORREVIO PHARMA - FDA INDICATED THAT CO WILL NEED TO DEVELOP APPROACH TO SELECT PATIENTS WHO ARE AT LOW RISK OF ADVERSE CARDIOVASCULAR REACTIONS
* CORREVIO - CURRENTLY BELIEVES THAT ENROLLMENT OF BOTH U.S. AND EX-U.S. SUBJECTS FOR BRINAVESS MAY BE ACCEPTABLE TO FDA BASED ON PRELIMINARY FEEDBACK
* CORREVIO - MADE A CLAIM AGAINST EDDINGPHARM (ASIA) MACAU COMMERCIAL OFFSHORE, LTD. IN RESPECT OF CERTAIN CONTRACTUAL BREACHES BY IT
* CORREVIO PHARMA CORP - EDDINGPHARM HAS NOT YET FORMALLY RESPONDED TO CO'S STATEMENT OF CLAIM
* CORREVIO PHARMA - EDDINGPHARM ARBITRATION PROCEEDING IS STILL IN ITS EARLY STAGES & EDDINGPHARM HASN'T YET FORMALLY RESPONDED TO CO'S STATEMENT OF CLAIM
* CORREVIO - FDA INDICATED DATA FROM ADDITIONAL, POTENTIALLY UNCONTROLLED, CLINICAL STUDY WILL BE NEEDED TO SUPPORT BRINAVESS' NDA RESUBMISSION