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Will Hemispherx BioPharma’s Orphan Drug Ampligen Receive FDA Advisory Committee Approval? :’s Perspectives

December 19, 2012

       On December 18, 2012, the FDA posted briefing materials for the December 20, 2012 FDA Arthritis Advisory Committee Meeting, that will review Hemispherx BioPharma’s orphan drug Ampligen for the treatment of Chronic Fatigue Syndrome (CFS). Ever since yesterday’s posting of the FDA Briefing Documents, the Internet chatter has been mixed as to whether or not Ampligen will get the approval vote of the FDA Advisory Committee. Currently, there is no FDA approved treatment for CFS.

       A December 19, 2012 article titled, “Hemispherx Faces FDA Day” presents yet another perspective on this debate :

  1. Hemispherx BioPharma shares plunged after the release of the FDA’s Briefing Documents, since many investors viewed the documents as “overtly negative”
  2. The article says investors “dramatically overreacted” upon the release of the FDA Briefing Documents
  3. Takes a look at the Advisory Committee’s voting members
  4. Suggests that the Advisory Committee will give a very close, but positive vote. had 2 other articles with opposing views on this debate in the last few days :

1) December 18, 2012 article titled, “Hemispherx’s Ampligen is Unlikely to Receive FDA Approval”

2) December 16, 2012 article titled, “Ampligen: Patient’s Will Determine Approval”.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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