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

Trending News

Inflammation Disrupts Memory - What Can You Do to Protect Your Brain?

All About Ginkgo Biloba: Benefits of This Timeless Herbal Supplement

Yarrow Oil: Here's Why It Deserves a Place in Your First-Aid Kit

Artificial sweeteners linked to risk of weight gain, heart disease and other health issues

Vitamin D supplement use associated with lower risk of breast cancer

Carnitine deficiency suggested as contributor to autism

Hop Oil: A Safe Sleep Aide

Lutein — An Important Nutrient for Eye and Brain Health

White Camphor Oil: The Purest Camphor Oil

Taurine: Facts About This Crucial Amino Acid

 
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."




Post a Comment

Featured Products From the ProHealth Store
Ultra EPA  - Fish Oil Energy NADH™ 12.5mg Vitamin D3 Extreme™


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Could a B-12 Deficiency Be Causing Your Symptoms? Could a B-12 Deficiency Be Causing Your Symptoms?
Are You Obtaining the Proper Enzymes? Are You Obtaining the Proper Enzymes?
A Hard-Working Molecule that May Help Ease Pain & Brighten Mood A Hard-Working Molecule that May Help Ease Pain & Brighten Mood
Aches and Pains? A Simple Solution You'll Love Aches and Pains? A Simple Solution You'll Love
The Surprising Benefits of Probiotics - What You Didn't Know The Surprising Benefits of Probiotics - What You Didn't Know

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map