ampligen sunk

Discussion in 'Fibromyalgia Main Forum' started by consuegra, Dec 1, 2009.

  1. consuegra

    consuegra New Member

    Hemispherx announced that they received a communication from FDA saying Ampligen cannot be approved at this time and another large trial would be necessary. This is not good news.

  2. TigerLilea

    TigerLilea Active Member

    From reading the letter from the FDA to Hemispherx, it doesn't sound like Ampligen worked that well for CFS.
  3. AuntTammie

    AuntTammie New Member

    where is a copy of the letter that we can read?
  4. TigerLilea

    TigerLilea Active Member

    >>>Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.<<<

    For the complete article go to

  5. TeaBisqit

    TeaBisqit Member

    The problem with the current formula of Ampligen is that you need it every day for the rest of your life. If you dare to go off of it, you get such a severe relapse that you end up permanently in a wheelchair or bedridden. And that is why I don't want to take it. This is what I gathered from people who have been on it.

    No insurance wants to pay for something expensive that alot of people will have to be on forever. And that includes medicaid/medicare. They are going to stall it off forever.

    There is no reason to keep doing endless trials for over twenty years. It's getting insane.
  6. dvdav2000

    dvdav2000 New Member

    Go to Yahoo.. finance.. go to HEB stock.. look at news... letter is there... then go to message board... stock down 44 % in after hours trading... terrible for HEB shareholders and CFIDS sufferers... or is it ???? there are people on their message board actually cheerign for co. to tank so they can make money... disgusting...

    Here is the only nugget...

    FDA wants another trial with 300 subjects... with some conditions... I have 2 words and our only hope for a trial success... ( if the therapy is meant to be for CFIDS ) those two words are KLIMAS, and FLETCHER... the most bankable CFIDS trials , researchers in the free world... sorry guys... it's true... they have the population, and the ability to get this done... please... please...

  7. denis321

    denis321 New Member

    I would have loved for Ampligen to work but from the little I've been able to read (hardly anything solid out there published about Ampligen), I am not suprised at what the FDA is requesting.

    I'm not annoyed at the FDA but more at the pharm company for not being more open about their studies. Since this is a privately funded trial, from my understanding, the company is under no obligation to ever release their results. Publishing info that Ampligen does not work well or is unsafe is bad for business but important for scientists/ physicians/ people to know. It also bothers me that some people suffered for this trial to, yes, get a chance to try Ampligen, but also to further CFS research and will not see their contributions to the latter goal.

    This is as opposed to government-funded studies which are required to have their results published or released in some manner.

    In the past, I've known some highly ethical people in academic research who signed agreeements when they took private funding that the researchers would ultimately have the freedom to publish what they found, regardless of results. I don't know if any researchers/ institutions still have this clout or if business has taken over. It seems like the latter unfortunately.
  8. aftermath

    aftermath New Member

    I have no financial position in the company, but put me at the top of the list of the people hoping that Hemispherx tanks.

    The best possible thing that could happen for us right now is for this POS company to go out of business. Everyone from Carter down to the janitors needs to be canned.

    Hopefully, a firm run by competent individuals will buy the Ampligen patent from the bankruptcy sale and actually have some success with it.
  9. UsedtobePerkyTina

    UsedtobePerkyTina New Member

    Is there nothing about this illness that isn't full of misleading statements, conflict, controversy and coverup?

  10. dvdav2000

    dvdav2000 New Member

    Well I am from NJ originally... Amp was offered in a trial type setting. You could pay to play or chance getting the saline for months and not being helped. Long trial

    Dr.. Podell in NJ, Lapp in NC, Bateman in Utah ?, and a couple of others did trials back in 2002-2004 ? if this is the data then.. yikes... HEB was merged in 2000 with a co. in NJ for the assets wqual both co.'s. Never had a straight story from these people. Very sad... stock in tank for years until the may june 2009 pump up to $ 4.00... now will fall to 40 cents if lucky by tomorrow... however there was a cash raise of 30 40 million in April, May... to keep the Hydra working... WE WANT THE TRUTH..
  11. simonedb

    simonedb Member

    you guys there could be much more to the story

    I have had cfs folks write me that ampligen saved them and that they were harrassed 10 years agoish by some short selling sob who was trying to defame ampligen cus he stood to make millions on shortselling of it, he followed cfs folks around at a conference and badgered them and got false statements about the drug in wall street journal at that time
    with that sort of manipulation and high stakes going on how can we hope to ferret out truth even from news articles?
  12. dvdav2000

    dvdav2000 New Member

    Hi All,
    If the science proved this could go to market then no shortseller, jack the ripper, or Geraldo Rivera could stop it... too much upside for the drug co. I have been watching this for years as you can see the SCIENCE isn't ther yet.... it is more procedural on the drug co.l than anything else... 20 years though... sorry state of affairs... WHY ??
  13. fight4acure

    fight4acure Member

    Thanks for posting this!

    Fight :)
  14. gapsych

    gapsych New Member

    I am glad the FDA did not approve this drug.

    Such oversight is vital to hopefully insure as much as possible that people are getting safe products.

    I can't believe that people would be using this shares as a means to make money. While this is legal with businesses who have shareholders, somehow, this makes me cringe.

  15. ladybugmandy

    ladybugmandy Member

    you don't need it everyday...i think it's twice a week.
  16. slammed

    slammed Member

    this crap has played on for 25 years. i have had enough. i don't really care who is winning and who is losing. our plight tied to this kind of bs? Enough
  17. ladybugmandy

    ladybugmandy Member

    this drug will probably only be used if there is a small pox outbreak. insurance just doesn't want to pay for IV drugs for millions of people...they would probably go bankrupt
  18. aftermath

    aftermath New Member

    "Short Sellers"--investors who position themselves to make money when a stock price falls--are not the cause of the problems with Ampligen. Short selling is par for the course with all small biotech stocks. All drug companies deal with it.

    The problems with Ampligen have been created and maintained by a totally inempt management staff at Hemispherx, the manufacturer of the drug.

    I have talked to most of the big name physicians treating this illness. The comment about Ampligen is almost always the same: "Interesting drug, made by a garbage company."

    I'm not going to name names, but if you go to a top doc, ask what they think of Ampligen and HEB.
  19. ladybugmandy

    ladybugmandy Member

    aftermath..i totally agree. HEB has had numerous opportunities over the years to partner with larger firms but has refused.

    the maker of ampligen is a genius but a madman.
  20. aftermath

    aftermath New Member


    I can't believe that they're still at it. These guys should just give up already.

    WPI will probably start from scratch and get something approved before these clowns come even close.