By end the January, 2013, at the latest,we will know if the FDA will approve Ampligen for ME/CFS...
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 chronic fatigue syndrome (ME/CFS).
In its response Hemispherx provided new data derived from a 24 week extension period occurring after the 40 week original trial.… Read More
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, his experiences with Ampligen.
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(Things are finally starting to move…The FDA is responding but no meeting dates are set. Stop now and we risk losing our chance; keep working and we can bust this thing wide open. We are on the brink of getting a historic meeting at the FDA…
The FDA can be very pro-active in the drug approval process – we’re simply asking that they be pro-active with the only major disorder they’ve never approved a drug for. – ME/CFS! Let’s keep the pressure on by emailing the feds every day until the 25th….Cort.)
To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS.… Read More
“We have an effective drug that’s very, very safe” Dr. Dan Peterson
Nothing better demonstrates the adage that ‘nothing comes easy in CFS’ better than the story of the only CFS drug to ever come before the Food and Drug Administration (FDA). Produced by a small pharmaceutical company called Hemispherx that, at least in its early years, displayed a propensity to get itself into lawsuits the drug has somehow managed to remain in limbo for over twenty years. Reports of its startling efficacy – at least in some patients – have both tantalized and frustrated an ME/CFS community for decades. Patients do have access to the drug in a few centers in the US but the high cost (>$1,000/month plus the expense of moving to the area) have kept most away.… Read More