San Diego, CA 7/9/2009 4:35:29 AM
Cardiome Pharma - Vernakalant Wait Taking a Toll, Analysis at SmallCapNetwork.com
Cardiome Pharma Corporation's (CRME) atrial fibrillation treatment vernakalant has been deemed 'approvable' by the FDA, but other information is still needed.
The wait has been excruciating for Cardiome Pharma Corp. (CRME) investors, not to mention unprofitable. Vernakalant, the company's effective atrial fibrillation treatment is effective to the point of being 'approvable' by FDA standards. However, the FDA's request for more safety information from all vernakalant studies (regardless of the ailment being treated) has dampened investor enthusiasm for shares of Cardiome Pharma.
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In order to approve Cardiome Pharma's drug, the FDA is asking for safety information surrounding the treatment, including the form and dosage of the drug. The concern stems from eight patients with compromised ventricular function. Without evidence of an acceptable efficacy risk/reward, the FDA could restrict the drug to only certain uses.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit the web site at www.cardiome.com.
Forward-Looking Statement: This press release may include or imply "forward-looking statements" within the meaning of the federal securities laws, commonly identified by such terms as "believes," "looking ahead," "anticipates," "estimates" and other terms with similar meaning. Although the Company believes that the assumptions upon which its forward-looking statements are based are reasonable, it can give no assurance that these assumptions will prove to be correct. Important factors that could cause actual results to differ materially from the Company's projections and expectations are disclosed in the Company's filings with the Securities and Exchange Commission. All forward-looking statements in this press release are expressly qualified by such cautionary statements and by reference to the underlying assumptions.
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http://community.smallcapnetwork.com/Four-Small-Cap-Biotechs-FDA-Favors-Two-Denies-Two/s/article/view/p/mid/1/id/134/
