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class action lawsuit against Hemispherx (ampligen makers)

Discussion in 'General ME/CFS News' started by leelaplay, Nov 11, 2009.

  1. leelaplay

    leelaplay member

    Co-cure sent this out today. It won't help ampligen at all.

    Dyer & Berens LLP files class action lawsuit against Hemispherx Inc.[/URL] - HEB Marketwire October 10, 2009

  2. dannybex

    dannybex Senior Member

    I knew this would happen...

    I've read about stockholders being extremely upset with the CEO...how he basically withheld information back in June, and also lied, saying the FDA approval would happen within 2 months -- a tactic which some claim was used solely to drive up the price of the stock, which worked: The stock price rose to something like $4.20 a share...and is now down at $1.20-ish. In the meantime, almost six months later, and they finally admit that the FDA needed more information all along. It never was going to be approved months ago.

    There were also allegations that he (or the company) deliberately lied about the phase 3 test results, as the percentages kept changing from the first press release to later ones.

    Amazing that Carter has not run the company completely into the ground. It's no wonder that Ampligen has been around for 30-35 years, yet never been approved by the FDA...


    p.s. Island Finn...the link didn't work...at least on my 'puter.
  3. starryeyes

    starryeyes Senior Member

    Bay Area, California
    From what I know of Ampligen, it makes some PWC feel better but they have to stay on it forever and it makes others much worse, permanently. That's why I think the FDA hasn't approved it.

    Hemispherx Biopharma did say that they were squeezed out of the last meeting by big pharma that could pay more for the better seats.

    I liked reading this:
  4. dannybex

    dannybex Senior Member

    Another article...


    "While delays are a normal part of the long and difficult process of getting a drug approved, what the market is punishing Hemispherx for, and rightly so, is the fact that the company had previously made statements that appeared to support the idea that the drug would win a marketing license in May, rather than the truth that its NDA filing was incomplete. What has added insult to injury is that Hemispherx took the opportunity to raise money not once but twice in May, bagging $34.4 million after the shares more than doubled as investors became increasingly excited as the PDUFA decision approached (Event - Hemispherx shares liven up ahead of chronic fatigue drug PDUFA date May 19, 2009).

    Confession Good for the Soul, Not the Shares

    After a wait of almost six months, the group has finally and formally informed the market that there are outstanding matters, including manufacturing issues, that it needs to sort out before there is any hope of approval.

    Given the nature of the issues it is clear that these would have existed as the group was approaching the May PDUFA date, making the chances of approval almost non-existent, a material event that the Hemispherx management team neglected to mention. In fact, the group issued a statement on May 26 claiming that approval would only be delayed by one to two weeks.

    However, since May there has been some impressive back peddling, and in August the group gave the first indication that all was not rosy in the garden, after it admitted it was working with its contract manufacturer, Hollister-Stier Laboratories, to sort out problems in the final part of the manufacturing process, which are now expected to be completed by the end of 2009."

  5. Solon

    Solon Guest

    Can someone explain how this drug is supposed to work?? Ok it might shift TH1/TH2 response somehow back to normal, but what does it do with CD4 cells, what with NK cells and what with the rest?? I have low B cells low CD4, and normal NK and CD8, would that particular drug help me??

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