Cytomedix says FDA appeal still pending |
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Wed, 18 Apr 2007 15:58
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ROCKVILLE, Md. (AP) - Biotechnology company Cytomedix Inc. said Wednesday the Food and Drug Administration is still evaluating the company's appeal of a denied marketing clearance for its wound treatment product.Cytomedix said it hopes the FDA will make a decision within two to three months.'While we had originally anticipated a decision by this time, we respect that the FDA is giving thorough consideration to our appeal,' Kshitij Mohan, the company's chief executive, said in a statement.The FDA in October denied the company's marketing claim that its AutoloGel wound-healing treatment is similar to others on the market, arguing that the use of a clotting agent derived from cows could cause complications involving the creation of antibodies that could cause a tendency for bleeding to develop in patients.The company, which said no such complications were found either in clinical trials or in medical reviews, has been pursuing an appeal. Cytomedix said in the statement that it has 'maintained open lines of communication with the FDA in order to ensure all questions are clarified and any relevant additional information is provided.'In addition, Cytomedix said it has learned that the FDA plans to consult with outside experts in wound care to get their opinions on the safety of the cow-based clotting agent, known as bovine thrombin.Shares of Cytomedix dropped 8 cents to $1.18 Wednesday on the American Stock Exchange.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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