Hemispherx reports approval of Ampligen for ME/CFS in Argentina.

[medfeb]

This approval is for the severe form of ME/CFS. Note that this does not automatically translate to approval in the United States or to other countries. They also need to work through "manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina."

An extract of the article is below. The full article includes additional details.

http://www.globenewswire.com/news-r...of-Myalgic-Encephalomyelitis-Chronic-Fat.html

First Product Approved for ME/CFS Indication Anywhere in the World

Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union

PHILADELPHIA, Aug. 23, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it has received approval of its New Drug Application (NDA) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The product will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world. We also believe that there are no other products in the pipeline for approval, worldwide, for this debilitating disease...

The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer. Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina. “Working closely with our partner in this effort, GP Pharm, our team at Hemispherx addressed all medical and scientific issues presented by ANMAT and deserves great credit for this major success. At Hemispherx, we may be small by big pharma standards, but our commitment to addressing this dire unmet medical need makes us mighty,” stated Hemispherx CEO Tom Equals.

Approval for commercial sale in Argentina provides a platform for potential commercial sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. Hemispherx and GP Pharm are now working to expand the approval of rintatolimod to additional countries with a focus on Latin America. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, adds further validation for the product as the Early Access Program (EAP) is launched in Europe....

 

[CaptainA]

I feel like approval in other countries is just a matter of time now. Also, does anyone know of any doctors in Argentina that are interested in treating people with it? If one or two of them were to specialize in treating people with Ampligen I could guess that a fair amount of people would travel to do it.

 

[Never Give Up]

Genetic Literacy Project has posted an article, not just the press release, on the topic.

https://www.geneticliteracyproject....e-syndrome-mystery-disease-causes-come-focus/

Written by, Ben Locwin, Ph.D., M.B.A., M.S. is a contributor to the Genetic Literacy Project and is an author of a wide variety of scientific articles in books and magazines. He is an expert contact for the American Association of Pharmaceutical Scientists (AAPS), a member in the American Statistical Association (ASA), and a consultant in the biological sciences, pharmaceutical, psychological industries and for academia. Follow him at @BenLocwin.

It's written from this perspective:

This(the approval of Ampligen in Argentina) is considered validation of claims by CFS sufferers that the condition is physical illness rather than a psychological one.

One of the hardest things to do in science is to pin-down confirmatory results of something not happening—or “proving a negative.” So for example, if you have a rare condition in the general public and you test out a treatment for it and wait to see if the treatment was effective… how long do you wait? How do you know if a period of time with unnaturally-few cases (or no cases) was due to the treatment working, or just that it was very rare in the first place so you’re witnessing small variations of something that almost never happens?

Such is the case with CFS. Not only do fewer than 0.33% of the public report Chronic Fatigue Syndrome, but validating improvement in a patient with CFS is very difficult because we are trying to assess the absence of symptoms, and these symptoms are often vague, non-specific, and very fluid in nature.

He picked out a few random bits of evidence supporting the biological origin of the difficult to pin down disease. He used the word "debilitating", but otherwise did not describe symptoms.

He tweeted it.

It is open for comments.

 

[CFS_for_19_years]

This arrived in an email today from Hemispherx Biopharma:
Biotech Update: Major Breakthrough for Hemispherx BioPharma, Inc.
Published on Aug 25, 2016
$HEB - SCN's Jane King sits down with CEO Thomas Equels of Hemispherx BioPharma Inc., (NYSE: HEB), and guest analyst Jeffrey Kraws of Crystal Research Associates, to discuss the biopharmaceutical company's recent drug approval.

Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the Argentine Republic. First Product Approved for ME/CFS Indication Anywhere in the World. Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union.