CEL-SCI Addresses Warning Letter in Regard to Statements on Its Corporate Website

CEL-SCI Corporation CVM announced today that it has received and responded to a Warning Letter issued to the Company by the Division of Drug Advertising Marketing and Compliance U.S. Food and Drug Administration regarding certain statements made about the Company's investigational therapy Multikine on its corporate website. The Warning Letter was issued by DDMAC on August 5, 2011. The letter identifies specific statements on various pages of the CEL-SCI website as promoting this investigational therapy as safe and effective for the purposes for which it is being investigated. CEL-SCI has already taken a series of actions to address the DDMAC letter. In CEL-SCI's response to the DDMAC, dated August 17, 2011, CEL-SCI detailed the specific actions taken by the Company to a) revise the statements identified by the Agency, b) disseminate the revised statements and c) identify the revised web pages on the CEL-SCI website. Furthermore, CEL-SCI's response letter describes additional actions that the Company is implementing to ensure that its website and the statements about the Company's R&D activities and investigational therapies on its website are in full compliance with FDA (DDMAC) requirements related to drug promotion and advertising.
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