Delays Keep Hemispherx (Amex: HEB) on Hold as FDA Staff Issues Come Into Play

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By M.E.Garza   
Tuesday, 26 May 2009 08:34

Investors and CFS patients eagerly anticipating approval from the FDA on Hemispherx Biopharma's Ampligen may have to wait as much as 1-2 additional weeks for a decision according to the company's latest news release and Form 8K filing.

Trading on Tuesday sent shares up over 25% and volume was up over 4 times the daily average on the news as investors interpreted the development as a positive sign that approval for the drug may be coming.

Hemispherx Biopharma, Inc. (Amex:HEB) today announced that the U.S. Food and Drug administration (“FDA”) has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen® (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company’s development plan for Ampligen® continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.

The delay has nothing to do with HEB or Ampligen and everything to do with the FDA, according to those familiar with the situation. In addition, the FDA did not request additional information.

Adrienne Dellwo, who serves as About.com's Guide to Fibromyalgia and Chronic Fatigue Syndrome had this to say to BioMedReports on the topic of Ampligen's approval:

"Of course, I hope that Ampligen will help a lot of people regain functionality and quality of life.  With any new drug, however, it takes time to figure out just how effective it's going to be, and for how many people.  On one hand, Ampligen's long, strange history casts some doubt on its effectiveness, but on the other hand some very prominent people in the CFS community have used it and believe it will change a lot of lives.

"The bottom line is that people with CFS need more treatment options, and studies show Ampligen may be a very good option, especially for certain CFS sub-groups.  For example, it could work wonders for someone with a post-viral case, but not for those who developed it after exposure to toxins.  I hope this is the treatment for which millions of people have waited."

Some are speculating that the delay may be, at least in part, due to the new appointment (confirmed by the Senate last week) of  Dr. Margaret A. Hamburg, as the new commissioner of the Food and Drug Administration.

The Wall Street Journal has just posted a story titled: "New FDA chief must divest several stock, fund holdings." In it, the Journal states that Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator.

Interestingly, a hedge-fund sponsor Renaissance Technologies, where Mr. Brown works owned 34,500 shares in HEB and added 23,000 more recently according to the latest Mutual Fund Facts report.

Hamburg is a former New York City health commissioner who also is a public health and bioterrorism expert. Hamburg told senators at her confirmation hearing that she wants to restore public confidence in the FDA by putting science first and by running an open and accountable operation. The FDA had been under criticism recently for its handling of several issues related to food and pharmaceutical products.

The company says it's development plan for Ampligen continues as described in their recently filed 10q and 10k.

 





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