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Tag Archives: Ampligen
CFSAC Comments August 2015: Ampligen Price Increase on Shaky Ground
I looked into the Ampligen issue–the exorbitant 267% price increase by Hemispherx–some more. Here is one thing that patients who are currently enrolled in the trial can do. They can contact Schulman Associates, the Institutional Review Board (IRB) for this … Continue reading
267% Price Increase for Ampligen
[Please see here for my follow-up letter to Dr. Woodcock.] I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research: Dear Dr. … Continue reading
Posted in Uncategorized
Tagged Ampligen, CFS, Chronic Fatigue Syndrome, Dr. Woodcock, FDA, HEB, Hemispherx, ME, ME/CFS, Myalgic Encephalomyelitis, Price Increase
31 Comments
Dr. Woodcock: Please Approve Ampligen Now!
My letter to Dr. Woodcock from earlier this week: Jeannette K. Burmeister [email] [phone] [street] [street] [city, state, zip code] … Continue reading
Posted in Uncategorized
Tagged 21 CFR §312.80, 21 CFR §314.105(c), 21 CFR §314.126(c), accelrated approval, Ampligen, April FDA Drug Development Meeting, Bexsero, CFS, Chronic Fatigue Syndrome, Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, Dr. Theresa Michele, fast track, Improvements in exercise capacity, Improvements in immune-system markers, Jeannette Burmeister, Joseph Pitts, Letter to Dr. Woodcock, life threatening or severely debilitating disease, ME, ME/CFS, meningitis, meningococcus B, Myalgic Encephalomyelitis, Princeton University, priority review, Serious or life-threatening disease, surrogate end points, U.S. House of Representatives, UCSB, Unmet need, Vaccine, Waive criteria for adequate and well-controlled studies
12 Comments
Thoughts on the May 2013 CFSAC Meeting
I’ll have a lot more thoughts about this week’s CFSAC meeting in Washington, D.C. once I get a chance to watch the videos because I wasn’t well enough to take notes or attend (or closely follow) the entire meeting. But … Continue reading
Posted in Uncategorized
Tagged Alaine Perry, Ampligen, Bob Miller, Case Definition, CFS, Chronic Fatigue Syndrome, Dr. Elizabeth Unger, Dr. Gailen Marshall, Dr. Howard Koh, Dr. Mary Ann Fletcher, Dr. Nancy Lee, Dr. Susan Maier, Eileen Holderman, FDA, Hemispherx, May 2013 CFSAC, ME, ME/CFS, Myalgic Encephalomyelitis, NIH, out of order, Seamon Corporation, Steven Krafchick
38 Comments
My Oral May 2013 CFSAC Testimony
My name is Jeannette B. I am relatively new to the advocacy world and I don’t have all the Washington insider lingo down yet. So, instead of “FDA” or “NIH,” I will probably say “the FDA” or “the NIH.” And since … Continue reading
My Written May 2013 CFSAC Testimony
CFSAC Meeting May 2013 Public Comment by Jeannette B., Attorney at Law My name is Jeannette B. I have been sick with ME for more than seven years. I appreciate the opportunity to address the committee today. I attended the … Continue reading
Posted in Uncategorized
Tagged Ampligen, CFS, CFSAC, CFSAC May 2013, Chronic Fatigue Syndrome, Dr. Dan Peterson, Dr. Enlander, Dr. Klimas, Dr. Kogelnik, Dr. Lapp, FDA, Kweder, ME, ME/CFS, Myalgic Encephalomyelitis, Theresa Michele
7 Comments
Public Comment at FDA Stakeholder Meeting, April 25, 2013
My name is Jeannette B. I am paying for my own expenses for being here for this meeting. I am here to urge the FDA to play a more proactive role in working with Hemispherx towards the accelerated approval of … Continue reading
Posted in Uncategorized
Tagged 2013, Ampligen, April 25, CFS, Chronic Fatigue Syndrome, FDA Stakeholder Meeting, ME, ME/CFS, Myalgic Encephalomyelitis
6 Comments
SF Chronicle Article on the FDA’s Denial of Ampligen
We got an article about the FDA’s denial about Ampligen on the front page of the San Francisco Chronicle’s weekend edition. I wish Dr. Montaya had framed his thoughts only positively (works in a sub-group of patients) instead of also … Continue reading
Sign the Ampligen Petition!
Please sign this urgent Ampligen petition. As many of you know, the FDA is about to make a decision on whether or not to approve Ampligen, the drug that has improved my quality of life dramatically with very little side effects. … Continue reading
Posted in Uncategorized
Tagged Ampligen, Bias, CFS, Chronic Fatigue Syndrome, Dr. Nancy Klimas, Effective Treament, FDA, ME, ME/CFS, Myalgic Encephalomyelitis
12 Comments
“I have a plane to catch”
I am still working through all the emotions triggered by the highly anticipated December 20, 2012 FDA Arthritis Advisory Committee meeting about the approval of Ampligen, an immune-modulatory drug that has been very successful in treating a sub-group of myalgic … Continue reading
My Oral Testimony at the AAC Meeting Regarding Ampligen on December 20, 2012
My name is Jeannette. I am very pleased to have this opportunity to address you and want to express my sincere thanks for your consideration of this critically important decision. I have suffered with CFS for almost 7 years and … Continue reading
Posted in Uncategorized
Tagged 2012, AAC, Ampligen, Arthritis Advisory Committee of the FDA, CFS, Chronic Fatigue Syndrome, December 20, FDA, ME, ME/CFS, Myalgic Encephalomyelitis
4 Comments
Ampligen Treatment Study (AMP 511) starting in San Francisco Bay Area
We are a group of ME/CFS patients coordinating contact information for those interested in receiving Ampligen in the San Francisco Bay Area in California. Sites administering the drug under the FDA approved open label AMP 511 study protocol have dwindled to Dr. Peterson in … Continue reading
Posted in Uncategorized
Tagged AMP 511, Ampligen, Ampligen Study, Bay Area, CFS, Chronic Fatigue Syndrome, ME/CFS, San Francisco
2 Comments
Llewellyn King Continues to Fight for Us: MECFS Alert Episode 1 (Parts 1 and 2)
Llewellyn King, a Washington columnist and executive producer and host of “White House Chronicle” on PBS, and his friend, Deborah Waroff, a New York writer and ME/CFS sufferer for 22 years, have started a new web-based TV show about Chronic Fatigue Syndrome, … Continue reading
Thoughts About M.E. 
You Can Make A Difference: Ampligen Approval Within Reach With Your Help
As many of you know, the Arthritis Advisory Committee of the FDA will meet in Silver Spring (outside Washington, D.C.) on December 20, 2012 to discuss the new drug application for Ampligen. I am registered to speak at the meeting … Continue reading →