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And a recent PR related to Ampligen and CFS/ME. AIM ImmunoTech Provides Update on Commercial Launch of Ampligen(R) in Argentina for the Treatment of Chronic Fatigue Syndrome Receives clearance from Argentina's FDA to import first shipment of Ampligen® for commercial sale in Argentina AIM...

You'll find this interesting - especially for those who were not around for the AdCom meetings of 2012-13. Maybe it can be used to petition the FDA. "Never mind that Hemispherx had demonstrated that the log transformation data was not warranted or that non transformed data was appropriate …the...

AIM ImmunoTech's Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome http://aimimmuno.irpass.com/ViewEmail.asp?b=2265&id=183751&p=2169290&I=1201116-E6Z6D3a5b9 AIM ImmunoTech Inc. Announces the U.S. Department of Defense's Award...

Hemispherx Links Stanford's ME/CFS Diagnostic to a Potential Path Forward for Ampligen Commercialization ... "This is a potentially landmark study on two fronts," said Thomas K. Equels, CEO of Hemispherx. "First, ME/CFS has been thought of by many as a psychological disorder without a physical...

LOTS of coverage. I hope it pans out. https://news.google.com/stories/CAAqOQgKIjNDQklTSURvSmMzUnZjbmt0TXpZd1NoTUtFUWlUaXBidmpZQU1FUlFFNFpKekZ6YWJLQUFQAQ?hl=en-US&gl=US&ceid=US%3Aen

They have 2 cancer trials underway, IRB approval to start the triple negative breast cancer and a planned start to ovarian trial at the end of this month - plus at least 4 more in the planning stages. These are trials of the toughest cancers and toughest patients - those who have failed...

Not to get technical Danny, but the Advisory Committee gave a mostly negative vote in December of 2012, with the FDA declining approval in February of 2013. However, I predict 2019 to be the year of HEB (or AIM as they will change their name). Both the CEO and the leading Cancer researcher are...

No details are known, I think they are still negotiating (and have been for a long while). My guess would be 300+

I've heard that Peterson is limiting his ampligen patients. The paragraph refers to a future planned trial (to satisfy the FDA, the 2nd confirmatory phase 3) and those that have received ampligen in any previous trial will not be eligible for the planned trial and thus the only way for those...

Indeed. That's always been the problem with the amp-511. Few can afford it.

Merged thread Hemispherx Biopharma Inc. Announces First Large Ampligen Shipment to a Clinical Site for Use in U.S. Expanded Access Program http://ir.hemispherx.net/profiles/investor/ResLibraryView.asp?ResLibraryID=89410&GoTopage=1&Category=2178&BzID=2265&G=980 Hemispherx recently announced...

Contact hemispherx to find out the status.... GP-Pharm is handling Argentina. http://gp-pharm.com/

That AMP-511 is a compassionate treatment protocol that’s been available for 20 years. FDA wants one more large trial. Argentina has approved.

Yes, by IV. It’s a large molecule drug, so it’s doubtful that will ever change.

From today's PR: In parallel, we continue to pursue Ampligen for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Ampligen is approved for this indication in Argentina (the first and only meaningful therapy approved anywhere in the world for ME/CFS) and is...

Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved Clinical Sites in Nevada and North Carolina "We view the compassionate care program as just a band aid for a much larger problem. We estimate over one hundred thousand...

cGMP = Current Good Manufacturing Practices

Hemispherx Comments on $500+ Million Market Opportunity for Ampligen®, the Only Late Stage ME/CFS Candidate in the U.S. . . . Dr. Daniel Peterson, a world renowned independent expert in the treatment of ME/CFS and in the clinical use of Ampligen® (or rintatolimod), states that it “… is a...

Here is a workshop announcement Link: http://solvecfs.org/fda-drug-development-workshop-dates-announced/ (The Federal Register link no longer works) And here is the industry guidance draft that the FDA came up with about a year later: (There are some transcripts as well...

Excellent letter by Hemispherx CEO. Filed with the SEC https://www.sec.gov/Archives/edgar/data/946644/000149315218000820/ex99-1.htm January 22, 2018 Thomas K. Equels, chief executive officer of Hemispherx Biopharma would like to draw your attention to a compelling new film that aired...