(NYSE AMEX: 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 (DDMAC) U.S. Food and Drug Administration (FDA) regarding certain statements made about the Company’s investigational therapy Multikine (Leukocyte Interleukin, Injection)* 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.
Geert Kersten, CEO of CEL-SCI, said, “CEL-SCI is fully committed to compliance with the law and to strict adherence with all governing laws, regulations, and policies, particularly those which are implemented and enforced by FDA, as well as those implemented and enforced by the other regulatory agency that shares significant regulatory oversight of our Company, the Securities and Exchange Commission (SEC). Consistent with CEL-SCI’s longstanding compliance policies and procedures, CEL-SCI is particularly committed to assuring that statements regarding CEL-SCI’s investigational medicinal products such as those cited in DDMAC’s letter – which are directed at fulfilling our SEC-imposed disclosure obligations, while also engaging in a full exchange of scientific information and thereby advancing scientific knowledge and fostering scientific research in medical fields relating to products we are developing – are truthful, scientifically accurate, complete, and non-misleading. CEL-SCI’s commitment and approach in these regards apply equally to communications online as they do to all other forms of communication. As a data-driven, research-based biopharmaceutical company, CEL-SCI has always actively engaged in a full exchange of scientific information, including disseminating scientific findings and communicating them through lay media outlets consistent with FDA’s regulations on investigational drugs. We have now stepped up our proactive compliance initiatives to ensure that we remain within the regulatory framework for such scientific-information-exchange.”