Hemispherx BioPharma (HEB)

[Iuhoosierben]

Article posted on NBC News 2 hours ago...

http://www.nbcnews.com/id/50666787#.UQwTm1qlszE

RENO, Nev. (KRNV & MyNews4.com) -- It's a debilitating disorder that effects at least one million Americans and now patients are speaking out. The drug they say that has changed their lives is up for approval with the US Food and Drug Administration. "I can go to ball games, watch my kids play their sports, I can just interact with them and without the drug I cannot," Chronic Fatigue Syndrome patient Robert Miller says. Janet Smith is urologist in Incline Village. Robert Miller of Reno is a father of two, they both battle Chronic Fatigue Syndrome. CFS is a disorder according to the National Institute of Health causes extreme fatigue, but not the kind of tired feeling that goes away after you rest instead it lasts for long periods of time and limits ordinary activity. Ampligen has changed their lives along with at least 70-percent of the patients they say their doctor has treated. But now the drug is facing scrutiny and they say it's come down to now or never. The FDA has until February 2nd to approve the drug's application. "It's time," Smith says. But when we met with Robert and Janet they were unsure of where the FDA was leaning and it has pushed them to a point of what Robert calls affirmative action. Robert has chosen to go on a hunger strike for the past two days and counting until the FDA makes a decision. When News 4 arrived at the Miller's home Robert was on the phone with a representative with the FDA. When asked how the phone call went Robert stated, "not reassuring." There is no universally accepted drug that is approved for CFS, but Robert and Janet rely on Ampligen designed by Hemispherx Biopharma. The company has been trying for 20 years to get the drug approved with the FDA. "In 20 years time there's been no question about his not being a safe drug. Now it comes D Day to make a determination and all of a sudden these issues are being raised about safety and there not being efficacy. It makes absolutely no sense to me," Miller says. Robert and Janet both feel now could very well be the last chance to get Ampligen approved. If it doesn't the say the company simply can't afford it and brining on new investors after a drug isn't approved by the FDA. They say would be difficult at best. Now all they can do is wait and time is running out. News 4 did contact the FDA and they say they are not allowed to comment on pending applications. We also spoke with Hemispherx Biopharma E xecutive Vice Chairman Tom Equels and he says the FDA does have the ability to push the date back and as of this afternoon they had not heard from the FDA.