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Subsequent Events
6 Months Ended
Jun. 30, 2012
Subsequent Events [Abstract]  
Subsequent Events

Note 15: Subsequent Events

 

The Company evaluated subsequent events through the date on which these financial statements were issued. On June 8, 2012, the Company and its consultants met with the FDA to discuss certain aspects of the CRL relating to its NDA for Ampligen® for the treatment of severely debilitated patients with CFS. Upon the Company's review of the FDA Minutes from this meeting, the Company believes the key points from the meeting to be undertaken by the Company in conjunction with its complete response include the following:

 

·         The FDA agreed to accept, for review, in Hemispherx' complete response new analyses of data from the AMP-516 Trial. Whether these data provide adequate evidence of efficacy will ultimately be a review issue, and there can be no assurance the FDA will conclude the data are adequate to support approval of the Ampligen® NDA;

·         As Ampligen® is a new molecular entity, the FDA anticipates that the data submitted in the NDA would be presented at a public FDA Advisory Committee meeting;

·         The FDA requires that the Company's complete response include all information necessary for review at the time of filing and that it address all deficiencies identified in the CRL;

·         The Company's New Brunswick manufacturing facility would be expected to be ready for GMP pre-approval inspection at the time of the complete response; and

·         The Company will include in the complete response a request for postponement of rodent carcinogenicity study requirements and a justification for this request.

 

The Company submitted the complete response to the FDA on July 31, 2012 in support of Ampligen®'s New Drug Application ("NDA") for Chronic Fatigue Syndrome ("CFS"). If found sufficient to support approval of the drug, these new analyses will be in lieu of an additional confirmatory Phase III study called for in the FDA's November 25, 2009 CRL. The FDA also advised that whether the new analyses provide adequate evidence of Ampligen®'s efficacy in treating CFS will ultimately be a review issue. The FDA has advised that, once submitted, the complete response will be on a six month review cycle at the FDA. The FDA's agreement to review the complete response does not commit the FDA to approve the Ampligen® NDA. Further, no guarantee can be made at this time that the facility will necessarily pass a pre-approval inspection to produce raw materials to manufacture Ampligen®, which is conducted in a separately dedicated area within the overall New Brunswick manufacturing complex. As a result of the FDA meeting, Hemispherx has redirected many of its resources to the Ampligen® NDA submission and its preparation for the FDA pre-approval inspections by reassigning personnel, hiring additional staff, consultants and various independent contractors.

 

Other than these events, the Company has determined that no subsequent event constituted a matter that required disclosure or adjustment to the financial statements for the six months ended June 30, 2012.