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Hemispherx Biopharma Inc Receives Complete Response Letter From FDA on Ampligen New Drug Application For Chronic Fatigue Syndrome

Monday, 4 Feb 2013 07:35pm EST 

Hemispherx Biopharma Inc announced that it received a Complete Response Letter from the US Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for Ampligen for Chronic Fatigue Syndrome (CFS). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its Complete Response Letter (CRL), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. In the two pivotal clinical studies that form the basis of approval for Ampligen, Hemispherx believes that the primary efficacy endpoints were met and that they showed a statistically significant improvement (i.e., with a p-value of 0.05 or less). The FDA and Hemispherx do agree that in clinical study AMP-502, the primary endpoint was met (p=0.02). 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. 

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