ProHealth me-cfs Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|

Trending News

10 Celebrities with ME/CFS

The Brain Boosting and Fatigue Fighting B-12

Severe ME/CFS - New Clinical Study

Norwegian ‘Woulds’ (and ‘Wouldn’ts’): The ME/CFS Survey

Altered immune response to exercise in patients with chronic fatigue syndrome/myalgic encephalomyeli...

Altered Distribution of Lymphocyte Populations in Chronic Fatigue Syndrome Patients

Simmaron Foundation’s Immunology Workshop: The Forefront of Diagnosing and Treating ME/CFS

VIDEO: Julia Newton Talks About Neurocognitive problems in ME/CFS

“Flowers” in the blood: A novel paired erythrocyte arrangement in a patient with chronic fatigue syn...

Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephal...

 
Print Page
Email Article

Ampligen New Drug Application Process Clears Another Hurdle

  [ 10 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 14, 2012


News today across the wired ME/CFS community is that...
The US Food and Drug Administration has accepted and pronounced complete Hemispherx Biopharma Inc.s ‘response submission’ regarding its New Drug Application for Ampligen® as a therapy for Chronic Fatigue Syndrome (ME/CFS).

On Aug 10, the FDA stated in writing that "We consider this a complete, class 2 response to our November 25, 2009, action letter.”

The decision begins a six-month FDA review cycle...
Including analysis of new supplemental clinical data that Hemispherx submitted to the FDA from its past Ampligen trials “in lieu of the additional confirmatory Phase III study originally called for in the Agency’s CRL.” (The FDA’s first Complete Response Letter to Hemispherx on Nov 29, 2009, regarding Hemispherx’s first submission of research data.)

For an explanation of the supplemental data involved, go to http://www.hemispherx.net/content/investor/default.asp?goto=736.

Hemispherx Executive Vice Chair Thomas Equels states...
"Since no drug has yet received FDA approval to treat CFS, we are committed to working with the FDA as well as making an all-out effort by our staffs in New Jersey and Philadelphia, along with the necessary and appropriate investment in additional personnel, equipment and other resources, in the hope of getting a treatment approved for people who must live with this severely debilitating condition."




Discuss This Article Post a Comment 




[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth

Natural Remedies

Live Longer: Groundbreaking Research on Omega-3s Live Longer: Groundbreaking Research on Omega-3s
2 test library cats 2 test library cats
"It's Not Easy Being Green" - But It Is Healthy
Undenatured Type II Collagen - Chicken Soup for Your Joints Undenatured Type II Collagen - Chicken Soup for Your Joints
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing