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==Drug approval status== ===United States=== [[File:FDA Review chart for Ampligen approval.png|center|frame|Source: Hemispherx Biopharma, Inc, Dec 2012]] Ampligen® has been passed through five different [[U.S. Food and Drug Administration|FDA]] review divisions since 1990. Hemispherx Biopharma, Inc, now AIM ImmunoTech, wrote in a presentation to the FDA on Dec 20, 2012: "Most products have [the] same review Division during their entire development. Guidance from five (5) different Divisions [has provided] diverged/conflicting advice on major points, such as: interpreting primary endpoints (method of analysis), its collection and analysis, and different thresholds for determining toxicity and safety. In contrast, AIM ImmunoTech has had the same medical monitor for more than 20 years (Dr. David Strayer)."<ref name="HemBio,2012" /> [[File:History of Hemispherx’s application for Ampligen.png|center|frame|Source: FDA website]] ::::::::::History of AIM ImmunoTech’s application to the FDA for Ampligen<ref>{{Cite web | url = https://web.archive.org/web/20130208065906/https://www.fda.gov/Drugs/NewsEvents/ucm337759.htm | title = Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS): Questions and Answers | last = | first = | first2 = | date = 5 February 2013 | website = FDA|publication-date=5 February 2013|archive-url=https://web.archive.org/web/20130208065906/https://www.fda.gov/Drugs/NewsEvents/ucm337759.htm|archive-date=8 February 2013|url-status=dead|access-date=February 5, 2013}}</ref> ====Expanded access ==== The AMP-511 [[expanded access]] program allows a limited number of patients access to Ampligen. ===Europe=== In 2016 Ampligen® started being made available on a limited basis in Europe.<ref>{{Cite news |url =https://www.bizjournals.com/philadelphia/news/2016/07/25/hemispherx-ships-ampligen-for-european-chronic.html | title = Hemispherx ships Ampligen for European chronic fatigue syndrome program | last = George | first = John | date = 2016-07-25|work=Philadelphia Business Journal | access-date = 2019-09-26|archive-url=|archive-date=|quote=}}</ref> === South America === [[Argentina]] (Argentine Republic) has approved the use of Ampligen® for [[Severe ME/CFS: A Guide to Living|severe ME/CFS]] on August 23, 2016. <ref>[http://www.globenewswire.com/news-release/2016/08/23/866212/0/en/Hemispherx-Biopharma-Announces-Major-Breakthrough-Approval-for-Commercial-Sale-of-Rintatolimod-U-S-Tradename-Ampligen-to-Treat-Severe-Cases-of-Myalgic-Encephalomyelitis-Chronic-Fat.html Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of] [[Myalgic encephalomyelitis|Myalgic Encephalomyelitis]]/[[Chronic fatigue syndrome|Chronic Fatigue Syndrome]] (ME/CFS) in the Argentine Republic - NasDaq GlobeNewswire</ref> Approval is limited to ME/CFS patients who are severely disabled and who have been diagnosed for more than one year.<ref name="Crystal, 2016" />
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