NetworkNewsBreaks – Cardiome Pharma Corp. (NASDAQ: CRME) Shares Sink on Disappointing Regulatory Feedback
Shares of Cardiome Pharma Corp. (NASDAQ: CRME) are down 33% near market close, though pulling from a new 52-week low reached earlier in the day’s trading session. Cardiome this morning said the U.S. FDA has advised that the company’s proposed data package would not would not be sufficient to support a resubmission of the BRINAVESS New Drug Application (NDA). BRINAVESS is Cardiome’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). “In our most recent communication with the FDA, we proposed resubmission of the NDA based upon the original file and six years of accumulated safety data…







