This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

CEL-SCI Addresses Warning Letter In Regard To Statements On Its Corporate Website

CEL-SCI Corporation (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.”

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,026.59 -43.81 -0.24%
S&P 500 2,112.66 -1.83 -0.09%
NASDAQ 4,999.8050 -17.1240 -0.34%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs