FDA still reviewing Cytomedix appeal on foot ulcer gel

Wed Apr 18, 2007 8:41am EDT
 
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April 18 (Reuters) - Cytomedix Inc. (GTF.A) said U.S. regulators are still reviewing the company's appeal regarding marketing clearance for it's gel for healing diabetic foot ulcers called Autogel.

The biotechnology company, in a statement, said it had originally anticipated a decision by this time. It said it hopes a decision would come within the next 60 to 90 days.

In October, the regulators denied Cytomedix's claim that AutoloGel was substantially equivalent to a legally marketed device.

(Reporting by Shikhar Balwani in Bangalore)

((Editing by Bernard Orr; Reuters Messaging: shikhar.balwani.reuters.com@reuters.net; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800)) Keywords: CYTOMEDIX FDA/

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