|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.
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 34,500Mutual Fund Facts report.shares in HEB and added 23,000 more recently according to the latest
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.