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

Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Social Anxiety Disorder Linked to High Serotonin Levels, Throwing Treatment with SSRIs into Serious ...

A short-term Borrelia burgdorferi infection model identifies tissue tropisms and bloodstream surviva...

Can Botanicals Beat Brain Fog & Fibrofog?

Therapeutic Effects and Mechanisms of Action of Rifaximin in Gastrointestinal Diseases

Immune response to a flu vaccine yields new insights into narcolepsy

Promoting Optimal Nutrition with Digestive Enzymes

Omega-3 supplements and antioxidants may help with preclinical Alzheimer's disease

Children with Lyme Disease

Health Benefits of Ginseng

7-Keto DHEA The Fat-Burning Metabolite of DHEA

 
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."



Please 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

Save on Nutritional Supplement Orders

Featured Products

Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Breaking Through the Mental Fog Breaking Through the Mental Fog
SAM-e: a Hard-Working Molecule that May Help Ease Pain & Brighten Mood SAM-e: a Hard-Working Molecule that May Help Ease Pain & Brighten Mood
Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
Magnesium: An Essential Supplement for ME/CFS Magnesium: An Essential Supplement for ME/CFS
Live Without Anxiety or Stress

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