ProHealth fibromyalgia 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

Orthostatic Intolerance, Part 1: Diagnosing OI

Yes, It Really Is Possible to Restore Mitochondrial Function!

Is Searching for THE Answer Making You Worse?

On Being Thankful for My Spouse as a Chronic Illness Sufferer

The Cure for Giving Up (When it Feels Like Chronic Pain Is Forever)

Orthostatic Intolerance, Part 2: Treating OI

Qigong and Fibromyalgia 

3 Surprising Tips for Better Sleep

Perfect presents for people with chronic pain

Making Scents of Pain Relief

 
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
Energy NADH™ 12.5mg Fibro Freedom™ Optimized Curcumin Longvida®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness
Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes

Natural Remedies

Fight Inflammation and Promote Cognitive Health with High-OPC Grape Seed Fight Inflammation and Promote Cognitive Health with High-OPC Grape Seed
How to Jump-start and Sustain Energy Production in CFS How to Jump-start and Sustain Energy Production in CFS
Block Acid Reflux to Prevent Esophageal Problems! Block Acid Reflux to Prevent Esophageal Problems!
Why Berries Offer a Rainbow of Health Benefits Why Berries Offer a Rainbow of Health Benefits
Help for Soreness and Swelling: What Do Silkworms Have to Do With It? Help for Soreness and Swelling: What Do Silkworms Have to Do With It?

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