logo
Plus   Neg
Share
Email

FDA Panel Rejects Hemispherx's Ampligen For Chronic Fatigue Syndrome; Stock Down

Hemispherx Biopharma Inc. (HEB) announced the outcome of the meeting of the Arthritis Advisory Committee of the U.S. Food and Drug Administration on the New Drug Application or "NDA" for Ampligen for Chronic Fatigue Syndrome or "CFS".

The vote was 8 to 5 against recommending the approval of Ampligen. However, the Advisory Committee backed safety profile of Ampligen.

Hemispherx said it is committed to the Ampligen clinical development program and to bringing Ampligen to market to ease the suffering of those seriously afflicted with CFS. The company said it will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen is a safe and effective treatment for CFS.

The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013.

HEB is currently trading at $0.28, down $0.08 or 21.39 percent.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shortly after announcing a racial bias training for the staff, Starbucks revealed its changed policy of allowing anyone to use its spaces, rest rooms, cafes and patios even without buying anything from the stores. The new policy will be consistent all across U.S. stores. Tesla Inc.'s CEO Elon Musk has revealed new specifications and options for its Model 3 electric car, including a high-end version of the sedan that will cost around $78,000. In a series of posts on Twitter Saturday night, Musk said that the Model 3 will be available in two versions, with dual motors and all-wheel drive in July. Musk also made an announcement regarding a new service program. Billionaire entrepreneur Elon Musk on Thursday showed off his concept for the Loop, a high-speed underground public transportation system that will carry up to 16 people and travel at 150 miles per hour. At the Boring Company Information Session, Musk and project leader Steve Davis provided details of the underground mass transit tunnels that the Boring Co. plans to build beneath Los Angeles.
Follow RTT