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Internet Chatter About The Posting Of FDA Arthritis Advisory Committee Briefing Documents For Hemispherx BioPharma’s Orphan Drug Ampligen

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). There is no FDA approved treatment for CFS.

The December 18, 2012 Internet Chatter on the FDA Advisory Committee’s posting of meeting materials :

***   1) December 18 2012 article titled, “Hemispherx Lied to Investors and SEC About Ampligen” :

–  Article says that Hemispherx BioPharma failed to “disclose serious concerns raised by the US FDA about its CFS drug Ampligen”

–  Article is very outspoken about how the meeting materials criticize the trial data & raise concerns about the efficacy & safety of Ampligen

–  “Hemispherx knew as early as this past summer that FDA wasn’t likely to approve Ampligen, according to new information released Tuesday (December 18, 2012) …. Withheld this significant information from investors and the SEC”.

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

–  Article reviews the documents for medical and scientific data and states that “Ampligen will not garner support from its advisory committee …. concerns about both Ampligen’s Phase III clinical trial data as well as Hemispherx’s response to the complete response letter it most recently received from the FDA ….. “

–  Ampligen does improve CFS symptoms

–  Shortcomings of Phase III trial

–    The company ahead of this advisory committee meeting chose not to perform additional clinical studies as the FDA recommended in a recent response letter.

***  3) December 16, 2012 article titled, “Ampligen: Patient’s Will Determine Approval” examines the history of the drug development, the history of the CFS community in relation to the CDC, and the role that patient advocacy will play in determining the outcome of the upcoming FDA Advisory Committee in 2 days.

4)  December 18, 2012 article titled, “Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review” :

–  Reports that Hemispherx BioPharma’s stocks are falling by almost ½ after rising > 200% this year, after the FDA questions whether or not Ampligen works

–  FDA also mentions that Hemispherx BioPharma was warned earlier in 2012 that their drug data may not support an approval

–  Per this article, the FDA expects a decision by February 2, 2012 (PDUFA date) per the Report.

5) December 18, 2012 article :

–  FDA in the briefing documents said that Ampligen lacks the required carcinogenicity tests.

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

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