Hemispherx Expands Ampligen Early Access Programme to Canada to Treat ME/CFS Patients
HEMISPHERX BIOPHARMA (HEB)
NASDAQ:AMEX Investor Relations:
hemispherx.net/mobile/investor-relations.php
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Source: GlobeNewswire
ORLANDO, Fla., April 04, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, said it amended its agreement with Netherlands-based myTomorrows to include management of a Special Access Programme (SAP) in Canada for patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). myTomorrows, Hemispherx’s exclusive service provider for early access programs in Europe and Turkey, will now also perform special access activities in Canada to include managing the supply of Ampligen® for the treatment of ME/CFS, for which there is currently no approved product in Canada. Ampligen is approved only in Argentina for severe ME/CFS. Hemispherx has a NDA on file with the U.S. FDA and is developing a protocol for a confirmatory Phase 3 trial. The first commercial size batch of Ampligen, which will contain ~8,300 vials, is anticipated to be available in May. This is the first of several lots scheduled over the next 18
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