Class Action Lawsuit filed-against Ampligen

Discussion in 'Fibromyalgia Main Forum' started by ulala, Nov 11, 2009.

  1. ulala

    ulala New Member

    producer, Henispherx Biopharma on Nov. 10, 2009.

    A Colorado law firm has filed a class action lawsuit against Hemispherx, the producer of Ampligen for misleading investors regarding the status of Hemispherx's New Drug Application ("NDA") for Ampligen with the U.S. Food and Drug Administration ("FDA").

    The stock dropped 10.83% this morning.
  2. mbofov

    mbofov Active Member

    But since Ampligen has been in the pipeline for almost 20 years as I understand it, I just wonder about the additional reports requested by the FDA - it seems they've had 20 years to get all their reports and it just seems like they've been stalling this drug forever (but I'm not up on what has actually happened here, it just seems a little suspicious to me, particularly given the CDC and NIH's total lack of response to CFS for 25 years, and I figure the CDC and NIH must have some influence with the FDA, and that if the FDA approved a drug which was effective for CFS, then that would be acknowledging that it's not all in our heads, contrary to CDC dogma).

  3. quanked

    quanked Member

    Article Preview

    Other News To Note

    BioWorld Today - Nov. 04, 2009


    â?¢ Hemispherx Biopharma Inc., of Philadelphia, revealed that it had outstanding queries from the FDA on the new drug application for Ampligen as a chronic fatigue syndrome treatment. The company had announced May 26 that the FDA had delayed the NDA decision, but had said then that the agency had not requested additional information from Hemispherx at that time. However, several outstanding NDA items requiring Hemispherx responses existed at the time of the FDA delay, which the company said it noted in its Aug. 8 10Q filing with the Securities and Exchange Commission. Hemispherx said that between March 9 and Sept. 15, it issued six new reports to the FDA spanning various subjects, including clinical safety assessments, specialized preclinical toxicology reports and abbreviated chemistry and manufacturing control reports. The firm said it also plans to submit four additional reports on interrelated topics in November and December, which Hemispherx said will include pharmacokinetic analyses in multiple lower animal species and final validation reports of certain manufacturing procedures conducted at an independent facility. Shares of Hemispherx (AMEX:HEB) fell 15 percent Tuesday, or 20 cents, to close at $1.13.

    [This Message was Edited on 11/11/2009]
  4. quanked

    quanked Member

    for tracking Amligen over time. I cannot help but puzzle over this company's handling of Ampligen.

    Hemispherx Biopharma, Inc. Files Lawsuit in Federal Court Alleging Conspiracy by Foreign Nationals to Manipulate Its Stock Price and Engage in Illegal Hostile Takeover

    Monday, 27 Dec 2004 08:56am EST

    Hemispherx Biopharma, Inc. announced that it has filed a lawsuit in federal court (Southern District of Florida) identifying a conspiratorial group seeking to illegally manipulate its stock for purposes of bringing about a hostile takeover of its Company. The lawsuit further alleges that, as part of a scheme for unjust enrichment, and following a change of control, the hostile takeover group planned to engorge themselves with additional Hemispherx shares by merging with worthless, privately held laboratory companies in which they are currently primary shareholders. Over a several year period, the conspiratorial group had experienced progressive financial difficulties including loss of liquidity, failed capital raises, failed efforts to launch their companies into the public stock markets, coupled with failure to develop commercially successful pharmaceutical products. The lawsuit alleges that the defendants, considering liquidation and complete loss of value in their illiquid investment, presented to Hemispherx, in person and in writing, merger proposals. Hemispherx's Board of Directors determined the proposed mergers as not being in the best interest of shareholders.

  5. TeaBisqit

    TeaBisqit Member

    I really hope one day that the truth will come out with this. Why is this the drug no one can have? They approve horrible drugs every day that hurt and kill people. But this, which has shown to help many people with CFIDS over the years was never allowed out. Why? Why was the choice to try this drug denied us? I want the truth. Could this have given some of us even half a life back all these years? How criminal to withhold it.
  6. simonedb

    simonedb Member

    REading this thread and the one about Dr Friedman on same page and date is really hitting me, wth? What is going on here, really seeming like a John Grisham novel, or is it just as simple as business as usual in the world of pharma and healthcare, maybe its evolved in such a corrupt way that its never a logical linear progression of disease research and treatment, all about who has something to gain by going in one direction or the other.


    is it more systematically targeted at cfs for some reason? we are the vax casualities or something like that and they dont want to admit it because to not vax the population would have potentially worse consequences? just one example, I have no clue.
  7. UsedtobePerkyTina

    UsedtobePerkyTina New Member

    A little business soap opera, huh?

    All we need is for our drug of hope to have a bunch of financial scandals. We already have enough controversy over the disease itself. And there is controversy in way CDC handles it. And there are small battles with doctors all over the world. Oh yes, let's not forget the UK and Simon.

    Is there anything that touches this illness that isn't controversial?

    I guess the complexity of the illness leads to all this other complexity and differing opinions and controversy.

    But you think a drug company doing research into a drug would be distanced from all of this. As an interesting twist, made for book as someone else said, wouldn't it be interesting if the lawsuit revealed a bias in the FDA that prevented quick approval? (Not that I am suggesting this is the case. It could be a case of misrepresenting the drug efficacy to get investors.)

  8. jasminetee

    jasminetee Member

    A rep from HEM stated in a video, might have been at the CFSAC, I think it was, that they are the little fish on the scene. The big pharma is buying seats or something closer to the FDA or something like that. At any rate, what Quanked wrote fits this and many of you like Tina see the writing on the wall.

    Greed is keeping this drug from us. I am sure of it.

    Mon Nov 2, 2009 8:46am EST

    Hemispherx Biopharma Updates Chronic Fatigue Syndrome (CFS) Treatment and Commercial Application Programs

    PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the “Company”), announced a two-prong CFS clinical mission for November and December 2009.

    The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome (please see October 8, 2009, online issue of Science). A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development (please see US National Institutes of Health at: ).

    With the consortium of researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled “Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome.” These immune defects may be due to the previously undetected retrovirus…

    Read full Press Release here:

    —————- Fibromyalgia and CFS Blog | November 3, 2009

    By Adrienne Dellwo, Guide to Fibromyalgia & CFS

    Dr. A Martin Lerner: Thoughts on XMRV (Updated), Ampligen

    In my recent conversation with Dr. A. Martin Lerner, a former chronic fatigue syndrome sufferer who says he used his specialty in infectious diseases to find treatments for himself and others, I asked him about both the XMRV discovery (which was just days old at the time) and also about Ampligen, the proposed chronic fatigue syndrome drug currently awaiting FDA approval…

    Read full article here:

    [This Message was Edited on 11/12/2009]
  9. simonedb

    simonedb Member

    I have been asking around trying to make sense out of all these apparent politics and a long time cfs sufferer told me how a short seller (stock market manipulator) harrassed her and cfs docs at a conference in late 90s when a lot of corrupt misrepresentation went down around cfs.
    journalists even seemed to be bought out at the time on side of stock manipulators.
    So can't they find a way to make money from this drug succeeding? I don't quite understand when its profitable for a drug to fail and when its profitable for one to succeed. Do the bigger co.s want it to fail so they can sell their drugs to cfs-ers instead of ampligen?
    WE need like Hilary Johnson to get on this story, I know some local journalists I could talk to, but all these different pieces of sabotage need to be revisited and visited, and I think its relevent to people without cfs in that realising that anyone may be being prevented from getting a new or old med or treatment that may be good for them just because its not currently profitable for big pharma.

    I don't know, maybe its an impossible task, can't win against the big guys. but wouldnt mainstream press exposure and redundancy eventually perhaps help?

    and I guess I am curious if rightnow, are you guys reading this as bad news for ampligen and xmrv or where IS this heading, like this lawsuit?

    [This Message was Edited on 11/12/2009]
  10. skeptik2

    skeptik2 Member

    Well, from what I remember, over the years, HEM has been embroiled in
    one controversy after another. They haven't seemed to do things the
    accepted way, and they are in big trouble for it.

    As to working with the WPI, I think that would be a good thing; they could
    do studies with XMRV patients and see if the Ampligen works for them;
    I know Mary Schweitzer is moving to Reno to get it the first of next
    year, as she's had a serious relapse, according to her blogs, and she
    needs it to survive. She has had it before, with good success, but has
    relapses and needs it again.

    Think about it: if it's approved somehow/someday for PWC/ME, there
    will be at least a million of us waiting in line for the treatment...who
    will give them, who will have centers where patients can go for the
    lengthy treatment? I just don't see it, do you? It would be like patients
    who have to go over and over again for kidney dialysis. If the FDA
    ends up having to approve it because it is in a clinical trial at the WPI,
    can you imagine the insurance companies' reactions? The cost is
    over $10K a year!

    You can bet the pharmaceutical companies will fight this tooth and
    nail, then add on the insurance companies...they all have an 'in' with
    the FDA, former FDA officials go to work for them very often.

    I'm not too hopeful, unless the meeting that took place in Cleveland,
    this past Wed. (Nov 11),of scientists from all over the country
    excited about XMRV, will be the beginning of validity and replication
    of the WPI findings.

    Even the test through the laboratory the WPI endorsed...what do
    we do if we are positive for XMRV? I'm not getting the test until
    it is validated by someone else, with CFS patients. I don't see
    the point, yet.

    Only time will tell how all this will shake out. Even if HEM is found
    to be culpable in some way, they will probably only be fined and
    allowed to do things the right way, the way the FDA needs.

  11. ladybugmandy

    ladybugmandy Member

    from the beginning, the story of this illness has been like an episode of the x-files. did they really think the pathogen would just disappear if everyone kept their mouths shut? they had to have known it would end up costing them more money in the long run....?

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