Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 In a message dated 12/28/99 2:16:32 PM Eastern Standard Time, schweit2@... writes: << Steve asked when Ampligen would be approved by the FDA -- boy, that's the something-million-dollar question! When will ANYTHING be approved by them?? >> Way back in 1991 or 1992, HEM (the name Hemispherx had then) was given an opportunity by the FDA to jump into large, double-blind trials. They didn't take the opportunty. The failure of FDA approval of Ampligen isn't due to the FDA. It has never had the testing provided to establish its safety or efficacy which the FDA demands of every drug. Until then, one cannot blame the FDA for anything to do with this drug. Gail Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 In a message dated 12/28/99 5:47:35 PM Eastern Standard Time, moores@... writes: << are the studies on AIDS any further along than the CFS? >> Steve, I couldn't resist answering this. No, they're not but the answers to " why not " will be in the upcoming National Forum and, later on, in a book that is due to come out in February by an ABC producer and investigational journalist. Gail Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 In a message dated 12/28/99 8:19:32 PM Eastern Standard Time, GAILRONDA@... writes: << < are the studies on AIDS any further along than the CFS? >> >> p.s. Steve, that had nothing to do with Ampligen!!! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 are the studies on AIDS any further along than the CFS? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 Thanks so much for your great summary on the " state of ampligen. " It really helped me to understand what is going on and what kind of hurtles we are facing. I just want at this point to interject a non-medical, non-political aside. I've noticed that in some of the press releases I've seen regarding Hemispherix, there is information about the company put forward by short sellers. These are people who sell a stock first, then look to buy it at a LOWER price. In other words, unlike normal investors, they are hoping the price of a company's stock will fall. They are as a group not particularly reputable, and they nearly put my husband's company out of business by starting patently false rumors on wall street (for example, that the govt was going to investigate them, which it was not; and that their plant was closed, which it was not) which caused the stock price to drop from 46 to 14 in a couple of hours and then to 7 the next day. If short sellers have a significant investment in Hemispherix, and it looks like they might, then you should take any information coming from the financial community with a grain of salt. They will be doing what they can to insure Hemispherix's failure. in North Carolina Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 1999 Report Share Posted December 28, 1999 >Steve asked when Ampligen would be approved by the FDA -- boy, that's >the something-million-dollar question! When will ANYTHING be approved >by them?? As a former FDA employee, I feel the need to speak up here. You wouldn't believe the pressures put on the FDA from " outside " political forces to release drugs etc. more quickly. A lot of people within the FDA are as frustrated as we are. I worked in CBER (Center for Biologics Evaluation and Research) in the Office of Vaccines. We were one small lab specializing just in pertussis (the P of DTP, also known as whooping cough) and we were getting swamped with applications for licensing acellular pertussis vaccine in combinations with other components and we were given a 6 month review time to go through piles and piles of documents from more than one company, and had a 12 month " clock " for others. With the current level of funding of the FDA and the enormous cutbacks on research, the staffing levels to deal with this " simple " vaccine issue was not up to the task without overburdening reviewers and nearly eliminating research. The work is getting done to the best of my knowledge, but the less research going on in the FDA labs, the less the reviewers know what to look for and how to protect the public health. Yes, I want to see things on the market fast too, but remember thalidomide? It was almost approved and that would have spelled a disaster of huge proportions. We can't always have our cake and eat it too. The FDA is not infallable, but they are the gold standard in many many countries. If the US FDA approves something it is often licensed in other countries based on our country's acceptance alone! Sorry for the rant, but you hit a nerve. Theresa Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 29, 1999 Report Share Posted December 29, 1999 In a message dated 12/29/99 11:34:58 AM Eastern Standard Time, nmcfadden@... writes: << ail, is this the hhv6 book due to come out by nicholas regush? nancym >> Yes, but our winter edition will come out with more specific information directly on ME/CFIDS. (As well as an article by Nick Regush.) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 29, 1999 Report Share Posted December 29, 1999 From: GAILRONDA@... a book that is due to come out in February by an ABC producer and investigational journalist. Gail ========== gail, is this the hhv6 book due to come out by nicholas regush? nancym Quote Link to comment Share on other sites More sharing options...
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