AMPLIGEN - FDA approval this week!

Discussion in 'Fibromyalgia Main Forum' started by SpiroSpero, May 24, 2009.

  1. SpiroSpero

    SpiroSpero New Member

    Hi all,

    just heard the news. The FDA will decide if they approve Ampligen on Monday or Tuesday. Cross your fingers.

    ""This drug (Ampligen) has been available to certain U.S. clinics for several years," says Adrienne Dellwo,'s Guide to Fibromyalgia & CFS. "And there's a lot of evidence (both clinical and experiential) showing that it works. Some doctors claim they've seen improvement in 80% of people with ME/CFS who take Ampligen, and significant improvement in about 50%. They say a lot of seriously disabled people have even been able to go back to work because of it."

    Results from a recent NewsScore Report survey of working doctors, appear to agree with Dellwo, particularly when the physicians were asked "If approved, do you feel Ampligen will likely become the standard of care for Chronic Fatigue Syndrome patients?" The majority responded that the scenario was "likely to occur."

    But what about Ampligen's role as "a booster" in fighting the flu?

    This week, Japan's Council for Science & Technology Policy (CSTP) awarded funds to advance research with influenza vaccines utilizing the adjuvant, Ampligen(r) (Poly I: Poly C12U). This after the number of swine flu confirmed cases in Japan has soared from four to 200 within days.

    If the Japanese data is deemed credible, and CDC experiments show protection against the H1N1 virus by using Ampligen as an adjuvant, "then you don't need another vaccine. You just mix in this adjuvant with whatever you make every season," Rodman & Renshaw's Piros said.

    While it is all speculation for now, "it could be the biggest surprise ever," he said."

  2. spacee

    spacee Member

    IMHO their willingness to treat CFS as a "real illness" has put pressure on our own FDA and CDC.

    And we can use all the pressure it takes.

    Thanks for posting.

  3. dannybex

    dannybex Member

    The diary of a woman who was on Ampligen for 8 years. Sounds like you have to stay on it forever, plus it's incredibly expensive...

    There's got to be other options...people do recover (even if it's rare) and usually do because they're not taking too many drugs. That being said, drugs can be helpful for short periods if the pain gets too bad, or one can't sleep.

    Don't want to be the Simon Cowell here, but don't think it's a good idea to hope for 'one pill' that will be 'the cure'. There are too many different causes of CFS/Fibro...

  4. outofstep

    outofstep Member

    Just to clarify-Ampligen isn't a pill-it's an infusion. It's an antiviral/immune modulator, so it will most likely be effective for those with chronic viral infections and immune dysfunction.

    Mary Schweitzer, a well-known CFS advocate, is the person whose diary you are referencing. She is also an advocate for this drug and credited it with keeping her out of a wheelchair-she's deteriorated since she was forced off of it last year. She has chronic HHV-6, Epstein-Barr and abnormal RnaseL.

  5. ulala

    ulala New Member

    does anyone know when it would be available for use? Does anyone know if Medicare will cover it? Anyone know what the supply situation is? If they want to use it for the flu we may have a hard time getting it.

    Do most people that are currently using it have an IV needle put in twicie a week? That's a painful procedure to have done twice a week. Or do they have a PICC line inserted?

  6. simpsons

    simpsons Member

    thank you for posting

  7. aftermath

    aftermath New Member

    I have serious doubts about the efficacy of this treatment, as does nearly everyone who had read about it.

    Still, if the drug is approved, I see it as a tremendously positive thing for this community overall. It will go a very long way in legitimizing this illness in the minds of mainstream Americans, including physicians.

    Moreover, if Hemispherex makes money with it, other pharma companies will see this and may devote resources toward research in the hopes of developing competing products.
  8. SpiroSpero

    SpiroSpero New Member

    Nearly everyone who bought some Hemispherx shares the last weeks is of course hoping that Ampligen will be approved. However there are a few people who say that the FDA will not approve Ampligen because by doing that they would clearly state that CFS is a real illness and not just a syndrome.

    I hope the shareholders are rewarded. The stock rose from 80 Cents to 2$ then back to 80 Cents and is now above 1$. If Ampligen gets approved I'm sure that the sharefolders will make profits of around 100 to 1000%. If not they will lose nearly everything and the stock will fall to 10 Cents or below.
  9. outofstep

    outofstep Member

    I've been watching the stock boards b/c they get the latest info the fastest-wish I had stock myself b/c if this is approved some people will make a lot of $. There's also the possibility that it could get emergency approval as an adjuvant to the flu vaccine-Japan is doing research on adding it to their vaccine right now.

    Since Hemispherx demonstrated improvement via the Fukuda definition it's still possible that the FDA could approve it w/o the CDC losing face-it was not tested as an immune regulator/antiviral even though that's what it is. Plus it has low toxicity and there is no other approved treatment. The CDC is also supposed to be working w/ Hemispherx now. Hoping for the best...
  10. outofstep

    outofstep Member

    Hemispherx Biopharma Press Release for
    Tuesday, May 26, 2009


    Philadelphia, PA, Tuesday, May 26, 2009: Hemispherx Biopharma, Inc. (NYSE/AMEX -HEB) today announced that the U.S. Food and Drug administration (“FDA”) has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen® (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company’s development plan for Ampligen® continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.
  11. SpiroSpero

    SpiroSpero New Member

    Hi outofstep,

    just read the news :(

    I hope so much that they approve it, the low toxicity in my eyes could be decisive in the approval.

    I keep my fingers crossed :D
  12. cfsgeorge

    cfsgeorge New Member

    Isn't this 2 week delay on top of the 3 month delay and the 1 year delay? The FDA really needs to get their act together. In the end, Ampligen better be approved.
  13. SpecialK82

    SpecialK82 New Member

    cfsgeorge - "The FDA really needs to get their act together" ROTFLMAO

    I am disappointed to see this pushed once again - When I first saw the press release I thought they were going to delay another few months and my heart sank - I was then actually relieved it said only another 1 - 2 weeks. Boy, it's no fun waiting by the table to hopefully get a few crumbs from the government....


  14. cfsgeorge

    cfsgeorge New Member

    I try not to express hate in public. I know how much we all despise the FDA. Let's just hope they do some good by finally approving Ampligen and not another freakin' A/D.
  15. outofstep

    outofstep Member

    from the biomedreports website:

    "Some are speculating that the delay may be, at least in part, due to the new appointment (confirmed by the Senate last week) of Dr. Margaret A. Hamburg, as the new commissioner of the Food and Drug Administration.

    The Wall Street Journal has just posted a story titled: "New FDA chief must divest several stock, fund holdings." In it, the Journal states that Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator.
    Interestingly, a hedge-fund sponsor Renaissance Technologies, where Mr. Brown works owned 34,500 shares in HEB and added 23,000 more recently according to the latest Mutual Fund Facts report.

    Hamburg is a former New York City health commissioner who also is a public health and bioterrorism expert. Hamburg told senators at her confirmation hearing that she wants to restore public confidence in the FDA by putting science first and by running an open and accountable operation. The FDA had been under criticism recently for its handling of several issues related to food and pharmaceutical products."
  16. ulala

    ulala New Member

    about the mandatory divestiture of their stock. I wonder if there would still be a conflict of interest if the company where Mr. Brown works owns a fund that owns HEB. Also very interesting that the Mr. & Mrs. Brown owned HEB. I wonder what the story is behind that? It shouldn't take several weeks for them to sell their stock. It can be done in seconds. I wonder why so much delay? Doesn't seem fair to the people that need the drug to move on with their lives.
  17. cfsgeorge

    cfsgeorge New Member

    Ampligen should have been approved before the current administration took over.

    Just 2 more weeks right? lol.
  18. outofstep

    outofstep Member

    yeah it just drags on and on rather sadistically-it's all very mysterious-seems that the patients are the least important aspect in all of this.
  19. ulala

    ulala New Member

    where the defense, who has been accused of a wrongdoing, does everything in their power, regardless of what damage is done to the plaintiff, to prolong, or tryf to prevent the case from going to trial.

    I wonder what is REALLY going on? Someone must have an agenda to keep Ampligen from being approved.
  20. cfsgeorge

    cfsgeorge New Member

    ........Ampligen doesn't get approved after all these delays and excuses? OMG!