Make Room on Your Calendar 20 Dec for the Live Webcast of the FDA Ampligen Hearing

Try to leave your calendar open from 8am-5pm EST on the 20th for the FDA’s hearing in Ampligen! Information about the meeting is available at December 20, 2012 Meeting of the Arthritis Drugs Advisory Committee (not mistitled!). The webcast will take place at and Phoenix Rising will attempt to embed the video locally to make it easier to simultaneously

The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier.

Ampligen On the Clock: Hemispherx’s ‘Complete Response’ Means Ball is Now in FDA’s Court Now

Posted by Cort Johnson Moving quickly, Ampligen’s producer, Hemispherx Biopharma,  filed its ‘complete response’ to the FDA’s request for data just 53 days after the agency agreed to relax its requirements for review of the drug.  Hemispherx’s ‘complete response’ means we will know by the end of January and perhaps sooner whether Ampligen becomes the first FDA approved drug for


Ampligen Resource Center

FROM PHOENIX RISING Blogs Ampligen on the Clock: Hemispherx’s ‘Complete Response’ Means Ball is in FDA’s Court Now – Hemispherx’s quick response means we will know if Ampligen becomes the first FDA approved drug for ME/CFS by the end of January, 2013. Major Move From FDA Puts Ampligen Back on Track (July 2012) –  in a major turnaround the FDA relaxes its

The Ampligen Chronicles by Kelvin Lord

After trying dozens of other treatments Kelvin Lord was on his last legs when he practically crawled in Dr. Lapps office in January 2010 for his first infusion of Ampligen, an immunomodulator under review by the FDA for ME/CFS, which was available to a only few doctors in the US. Chart Kelvin’s progress as he describes, in sometimes side-splitting fashion,


Major Move From FDA Puts Ampligen Back on Track

Posted by Cort Johnson Reversing a 2009 decision some commentators felt was  potentially crippling to Hemispherx BioPharma, Ampligen’s producer, the FDA today stated they would not, after all, require a expensive  300 person study to assess Ampligen’s effectiveness in chronic fatigue syndrome (ME/CFS). (Safety concerns appear to have been taken care of.)  Instead they would allow Hemispherx to use new


Ampligen Study Take II: A Correction

Posted by Cort Johnson The recent blog on Hemispherx’s Ampligen study has been amended to take account of the fact that the study involved an analysis of data from a 1998-2004 study. The blog in its original state suggested that this was a new study done in response to the FDA’s 2009 concerns. That was not true. Hemispherx may have


Ampligen I: Effectiveness

Ampligen (AMPlIfied GENetic Activity) is a double-stranded RNA molecule developed in the 1960’s by Merck and Co to reduce tumor formation. Effective in the lab but too toxic for use Ampligen languished until Dr. William Carter, working with other Johns Hopkins University researchers in the 1970s, was able to reduce its toxicity. Ampligen’s reported mode of action – bolstering the