Hemispherx Press Release on FDA's Decison on Ampligen

Discussion in 'Fibromyalgia and ME & Chronic Fatigue Syndrome' started by MicheleK, Feb 4, 2013.

  1. MicheleK

    MicheleK Member

    Here it he link to the press release released by Hemispherx regarding the FDA's decison not to approve Ampligen.

    http://boardvote.com/symbol/HEB/communique/206757

    "Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research regarding the Agency's decision. The purpose of the conference is to review all of the issues raised in the Agency's CRL as well as to discuss the corroborating data and experiences of clinicians and patients who have seen the benefits of Ampligen® therapy."

    In the past, the FDA has shown great willingness to work with stakeholders to find solutions for serious and life-threatening illnesses. Dr. Margaret Hamburg, Commissioner of the FDA has previously stated that, "FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges."

    "Hemispherx hopes that the FDA will view the Ampligen® end-of-review conference as an opportunity to involve patient advocacy, clinicians and researchers in a concentrated effort to do something for these patients over the near-term, including further evaluation of how new legislation, such as the recently enacted "FDASIA" statute, may have a role in finding a solution."