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Hemispherx Biopharma Inc. (AMEX: HEB) Files New Drug Application with the FDA

Hemispherx Biopharma announced today that it has filed a new drug application with the U.S. Food and Drug Administration for its experimental therapeutic which is designed to treat Chronic Fatigue Syndrome. The company also announced that it is moving forward with filings in other countries.

Chronic Fatigue Syndrome could be affecting more than 1 million people in the U.S. and causing an economic impact of more than $9 billion dollars every year. The Centers for Disease Control (CDC) claims that Chronic Fatigue Syndrome is “as disabling as other severe chronic conditions like multiple sclerosis, Chronic Obstructive Pulmonary Disease and rheumatoid arthritis.

William A. Carter, M.D., Chief Executive Officer and Chairman of Hemispherx, stated, “The comprehensive data package being submitted today has been possible because of the guidance, and scientific support, of the FDA, the CDC and CFS Advisory Committees to both the government and the private sector. Our profound gratitude goes out to the teams of independent clinical investigators around the country and, especially, to the individuals afflicted with CFS who supplied the courage and will to sustain the research, clinical and regulatory communities in their continuing search for better understanding and management of CFS.”

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