The Best of 2012 #9: Hemispherx BioPharma

• Report this Comment On December 13, 2012, at 7:10 PM, don509 wrote:

  First, while David can giggle like a schoolgirl throughout his bash of HEB, it does nothing to endear him or Motley Fool to those of us who are both Motley Fool subscribers and stockholders in HEB. My subscription comes up again in April. If HEB gets any kind of approval from the FDA, my subscription will be ending.

  Is David aware of the Food and Drug Administration Safety and Innovation Act (FDASIA)? He doesn't seem familiar with it, or how it may apply to HEB. He should have read up on this before taping his slam, but it would still serve him well to read it now, as this will not be the last company to come under this act.

  As a subscriber, I am not happy with this amateurish video review.

  David had better hope that he isn't wrong in his prediction.

  thank you.

• Report this Comment On December 13, 2012, at 10:05 PM, r00kie888 wrote:

  LOL, he couldn't even read the cr@p with a straight face.

• Report this Comment On December 15, 2012, at 8:36 PM, HarryDache wrote:

  He is giggling,obviously he hasn't read the FDA transcript to HEB dated Sept. 13, 2012

  http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf

  It is very encouraging. Maybe if he did, I don't think he would have made a fool of himself

• Report this Comment On December 20, 2012, at 11:17 AM, HeartForward wrote:

  I am posting here also what I already posted yesterday on another article written by our Fool's colleagues David Williamson and Max Macaluso regarding the FDA review of Ampligen (HEB).

  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 11:19 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... see why the FDA must approve Ampligen for ME/CFS. People's lives are at stake.

• Report this Comment On December 20, 2012, at 11:29 AM, HeartForward wrote:

  Another well-written article by Llewellyn King from the White House Chronicles (CBS). FDA to rule on 'Lazarus' drug (Dec 20, 20212)

  http://www.stamfordadvocate.com/local/article/FDA-to-rule-on...

  "...According to (Dr. Andreas) Kogelnik, some patients react poorly right off the bat, while others show substantial improvement almost immediately.

  Mary Schweitzer, a CFS sufferer, said that she can only walk when she is getting Ampligen. She travels regularly from her home in Delaware to New York, where Dr. Derek Enlander, who specializes in CFS, is a major proponent of Ampligen therapy.

  Even devout proponents of Ampligen do not tout it as a cure but as a therapy that helps them move about and approach a kind of normalcy...."

  "..."The suffering is immense. Many patients have to lie in bed for 18 hours a day, as I did before Ampligen, needing care and not having a life of their own. Many patients have lost all friends and family."

  Llwellyn King's well explained position is to the point:

  "When patient activists face the government in various hearings, it is painfully asymmetrical, it seems to me. The sick tell sad stories of suffering, loss of love as well as health, while the government people talk abstractly about patient loads, international disease definitions, allocation of resources and appear self-important rather than appalled at the suffering that passes before them.

  The patients turn to the government for recognition, but the government turns them into a statistic."

  Read more: http://www.stamfordadvocate.com/local/article/FDA-to-rule-on...

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