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Hemispherx Biopharma, Inc. Message Board

  • macrocosmonaut macrocosmonaut May 25, 2009 8:03 AM Flag

    FDA comments on Ampligen - life threatening reactions?

    At 1991 FDA wrote:

    >>In addition to numerous deficiencies in the application, the agency is concerned particularly about the serious and potentially life-threatening reactions that were observed during the study, and the conduct of the study in general. These serious reactions included acute hepatic (liver) toxicity, severe abdominal pain and irregular heartbeat...<<

    http://www.fda.gov/bbs/topics/ANSWERS/ANS00350.html

    I can´t imagine that this is not existing anymore.

    I has more trust in the FDA than in the management, which said that no adverse reactions has been observed!

    Many open questions to me? Why this liver toxity and arrythmia of the heart? Life threatening and severe reactions on the drug!?

    Approvable??? From my point of view: No.

    Classaction law suits against the management in future: Yes.

    IMO.

    Do your own due dilligence.

    Good luck to all.

    M.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • OH no.....


      I could give a shit less....

      I want every else to know what a creepy little lieing shit you are

      A good trick would be to put me on ignore for everyone else....


      Let me know when you can to that



      you cowardly pos.....

    • I put you on ignore - it even plays no role what I am thinking.

      FDA rules - nobody else.

      M.

    • Why this liver toxity and arrythmia of the heart


      marco is a stock manipulating pos... first pump then dump....


      Here is the deal first with liver toxicity...

      One patient in the phase II (none in the phase III)
      had high liver enzymes.... that patient was pulled from the study and apparently the doctors agreed it wasnt caused by ampligen and let that patient rejoin the study and no problems occured after that.... conclusion not caused by ampligen....

      The heart arrythmia thing is goofy....


      just a couple months ago heb presented data the fda requested...


      it was found that the ampligen side was heart protective....


      So the trolls tend to use old crap....


      The fda eventually was satisfied with hebs answer because they allowed both the phase III and an open label study....


      macro is a dummass....

    • Are we going back 18 years to find things to post on the message board that all of us already knew. Many things are done differently then 1991. They adjusted dosage and the liver toxicity, heart beat issues, and stomach pain have been eradicated. I will get the link and post it here. I just had to laugh when I saw the date of the review. They wouldn't even allow the NDA back then. Now? Uh, yes the NDA is submitted and accepted. That should quell concerns but I will find the link none-the-less!

    • 1 rationalize before you cut and paste.
      2 won't be the first to be approved with hepatotoxic s/e.
      3 orphan status and risk benefist ratio on our side.
      4 go work on scaring the adls people they too have a drug coming up soon, in a class of hepatotoxic meds!

    • Give it up..

    • Macro-

      Don't you understand? You have lost ALL credibility on this mb. due to your sudden change in attitude. A couple of days ago: macro, sentiment strong buy - now: strong sell. Forget it. Die Gier hat Dir das Gehirn benebelt. Let that be said by someone who is quite fluent in German. Spiel' lieber Fagott....
      Now begone!

 
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