ProHealth health 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

Gut Bacteria, Artificial Sweeteners and Glucose Intolerance

Vitamin E intake critical during 'the first 1,000 days'

Turmeric compound boosts regeneration of brain stem cells

Lower risk of mortality over thirteen year period in association with higher levels of vitamin D

Culprits of Autism Identified: Toxins, Gut Bacteria, Nutritional Deficiencies, and Vaccines Made wit...

Use of Broad-Spectrum Antibiotics Before Age 2 Associated with Obesity Risk

VIDEO: Beautiful Clouds - Relaxation and Meditation

The Fast-Acting Solution for Healthy Digestive Function

Elevated plasma biomarkers of chronic inflammation in Gulf War illness

Higher vitamin E intake linked with lower blood pressure

 
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 Vitamins and Supplements

Featured Products

Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Vitamin D3 Extreme™ by ProHealth Vitamin D3 Extreme™ by ProHealth
50,000 IU Vitamin D3 - Prescription Strength
Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Running on Empty? Fuel Up with NADH Running on Empty? Fuel Up with NADH
The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health
The Big Blue Fish that Helps Chase the Blues Away The Big Blue Fish that Helps Chase the Blues Away
The Curcumin Revolution: The Curcumin Revolution: "Golden" Ticket to Better Health
Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10 Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10

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