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Re: DewDiligence post# 202857

Monday, 08/21/2017 4:50:22 PM

Monday, August 21, 2017 4:50:22 PM

Post# of 253213
CRME -33% on regulatory setback:

https://finance.yahoo.com/news/cardiome-provides-u-regulatory-brinavess-120000024.html

Cardiome Pharma Corp…today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for BRINAVESS (vernakalant hydrochloride, IV), the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its written reply, the FDA advised Cardiome that the data package proposed by Cardiome would not be sufficient to support a resubmission of the BRINAVESS New Drug Application (NDA).


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