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Hemispherx Hopes To Ride Retrovirus Discovery To Ampligen Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

One year after receiving an extensive “complete response” letter for the chronic fatigue syndrome therapy Ampligen (rintatolimod), Hemispherx Biopharma, Inc. is working to revivify the drug’s clinical prospects by applying recent discoveries about the potential role of a retrovirus in CFS to its dataset.

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Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval

FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.

Ampligen Chronic Fatigue Syndrome Data May Be Sufficient For FDA Approval

FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.

Ampligen Will Be Early Test Of FDA Consolidation Of Chronic Fatigue Drug Reviews

FDA’s decision to consolidate oversight for chronic fatigue syndrome treatments in the Division of Pulmonary, Allergy and Rheumatology Products will face an early test with Hemispherx Biopharma Inc.’s expected submission of an amended NDA for its investigational agent Ampligen in the third quarter.

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