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Business
12 Months Ended
Dec. 31, 2011
Business  
Business

(1)   Business

 

Hemispherx Biopharma, Inc. ("Company") is a specialty pharmaceutical engaged in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders, The Company was founded in the early 1970s doing contract research for the National Institutes of Health. Since that time, the Company has established a strong foundation of laboratory, pre-clinical, and clinical data with respect to the development of nucleic acids to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain chronic diseases.

 

The consolidated financial statements include the financial statements of Hemispherx Biopharma, Inc. and its wholly-owned subsidiaries. The Company has three domestic subsidiaries BioPro Corp., BioAegean Corp. and Core BioTech Corp., all of which are incorporated in Delaware and are dormant. The Company's foreign subsidiary, Hemispherx Biopharma Europe N.V./S.A., was established in Belgium in 1998, and has minimal activity. All significant intercompany balances and transactions have been eliminated in consolidation.

 

On July 7, 2008, the FDA accepted for review the Company's New Drug Application (NDA) for Ampligen®, an experimental therapeutic to treat Chronic Fatigue Syndrome (CFS), originally submitted in October 2007. The Company is seeking marketing approval for the first-ever treatment for CFS.

 

On November 25, 2009, the Company was notified in a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") of specific additional recommendations related to the Ampligen® NDA. In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they could not approve the application in its present form and provided specific recommendations to address the outstanding issues. The Company continues to review the CRL and will seek a meeting with the FDA to discuss its recommendations upon the compilation of necessary data to be used in their response. On December 2, 2010, the FDA granted the Company a one year extension to file a response to the CRL based on the submission of new data concerning the potential viral etiology of CFS. In January 2012, the FDA granted an additional extension to file a response to the CRL. Unless communicated otherwise by the FDA, the extension will remain open while the Company continues to amend the NDA. The Company is currently conducting an open-label treatment protocol in the U.S. and evaluating new diagnostic modalities to provide additional insights into the CFS disorder. It is their plan that the new analyses and other insights will supplement the original study findings. The Company believes that continued efforts to understand existing data and to advance the development of new data and information, will ultimately support a re-filing of the NDA.