Hemispherx's Unsurprising 45% Plunge

Shares of Hemispherx (NYSEMKT: HEB  ) climbed almost 200% in 2012 over investor excitement that the company would be resubmitting its chronic fatigue syndrome drug Ampligen for approval from the Food and Drug Administration. The FDA rejected the drug in 2009, citing insufficient efficacy and safety data, but rather than conducting further trials, Hemispherx attempted to simply rework the data it already had. Apparently, the agency disagreed with that approach as negative briefing documents ahead of Thursday's advisory committee meeting sent shares down 45%. In this video, Motley Fool health care analyst David Williamson takes us through just how bad the damage is.

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  • Report this Comment On December 19, 2012, at 2:12 PM, HeartForward wrote:

    As a member of the Motley Fool community and as an stakeholder in the ME/CFS community, as a patient and an advocate, I believe that the FDA must approve Ampligen under the “accelerated approval” process because despite the hurdles mentioned in the FDA report about Hemisphererx, it has not escaped to me and to the patient community and other stakeholders, that the FDA after 10 years or more of avoiding the issue, has begun to be part of the solution process for a cure for such a debilitating and life threatening NeuroEndocrineImmune disease) such as myalgic encephalomyelitis (ME), also known in the U.S. as chronic fatigue syndrome (CFS).

    I have been working as an advocate towards approval of drugs and treatments for ME/CFS for the past 14 years. I believe the FDA will approve Ampligen tomorrow under the "accelerated approval" process for orphan drugs. In fact I would add that Ampligen could also fall under Fast Track and Priority Review as well. See FDA guidelines here: http://www.fda.gov/forconsumers/byaudience/forpatientadvocat...

    I have witnessed first hand the glaring changes experienced by many ME/CFS patients who are on the drug and the devastating results when they are off the drug. The lack of understanding of what ME/CFS is by the U.S. Heath Government officials,) including a clear criteria definition, and by scientists and the medical community in general have placed a huge burden of proof in a yes, struggling but indeed dedicated small biopharma to tackle a debilitating, chronic and often life threatening disease that causes at least $23 billion annually to our economy (DePaul University – Leonard Jason et al).

    Here is one analyst’s view on an article that has made some of the same points I am proposing here: http://seekingalpha.com/article/1072481-hemispherx-faces-fda...

    Disclaimer: I own shares of HEB. I suppose I am placing my money where my mouth is.

  • Report this Comment On December 20, 2012, at 11:12 AM, HeartForward wrote:

    Here is a follow up to my comment dated Dec 19, 2012. Please go to my blog agent4change at http://agentforchange.blogspot.com/2012/12/fda-review-of-amp... to see why the FDA must approve Ampligen for ME/CFS. People's lives are at stake.

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