Hi Sasha, the company has had a bumpy road, some of it their fault and some not.... but I think no one would like to see ampligen approved more than the company itself. Much of he distant history is outlined in "Oslers Web" and much of the "bad management" rap comes from short sellers trying to down the company for their financial benefit - which is criminal, the short sellers should be put in jail. I have no problems with management the past 5 years.
I don't give investment advice, but let me give you a different perspective. The company is small, it usually take a billion dollars to develop a drug, Hemispherx has spent over half a billion trying to commercialize ampligen. It ain't cheap or easy. ME/CFS is the largest unmet medical need in this country and no other biotech's are actively trying to develop drugs for ME/CFS. In 1997 Hemispherx undertook ME/CFS trials, a disease of unknown etiology, with no standard diagnosis with a drug whose mechanism of action was little understood. This is remarkable... astounding. In 2005, the mechanism of action was discovered - ampligen is a Toll-Like-Receptor 3 agonist. (TLR-3 is a viral pathway). In 2009 the ME/CFS connection with XMRV was discovered. The company recently ran a retrospective on their Phase III data, they had the WPI test trial participants for XMRV and found that 97% of the XMRV+ participants improved greater than/or equal 25% in ETT (treadmill test), (67% of the XMRV- participants had the same improvement) .. improvement was from baseline. This is a new endpoint, which according to the company has the FDAs blessing. The old endpoint was from the average mean baseline. Big difference. The company intends to undertake another Phase III and if those numbers hold, the chances of approval, IMO, are great.
Ampligen is no cure, but it does alleviate symptoms in about 70%. Dr. Lapp has good insight in this article and he should know. http://ampligen-treatment.blogspot.com/2010/10/interview-with-dr-lapp-pioneer-and.html
So Sasha, don't knock Hemispherx too much - so far, they are the only biotech actively working on getting a beneficial drug approved for ME/CFS. Peterson and Lapp believe that in future trials, ampligen will be combined with anti-retrovirals - which sounds like the best hope for ME/CFS sufferers.
I don't give investment advice, but let me give you a different perspective. The company is small, it usually take a billion dollars to develop a drug, Hemispherx has spent over half a billion trying to commercialize ampligen. It ain't cheap or easy. ME/CFS is the largest unmet medical need in this country and no other biotech's are actively trying to develop drugs for ME/CFS. In 1997 Hemispherx undertook ME/CFS trials, a disease of unknown etiology, with no standard diagnosis with a drug whose mechanism of action was little understood. This is remarkable... astounding. In 2005, the mechanism of action was discovered - ampligen is a Toll-Like-Receptor 3 agonist. (TLR-3 is a viral pathway). In 2009 the ME/CFS connection with XMRV was discovered. The company recently ran a retrospective on their Phase III data, they had the WPI test trial participants for XMRV and found that 97% of the XMRV+ participants improved greater than/or equal 25% in ETT (treadmill test), (67% of the XMRV- participants had the same improvement) .. improvement was from baseline. This is a new endpoint, which according to the company has the FDAs blessing. The old endpoint was from the average mean baseline. Big difference. The company intends to undertake another Phase III and if those numbers hold, the chances of approval, IMO, are great.
Ampligen is no cure, but it does alleviate symptoms in about 70%. Dr. Lapp has good insight in this article and he should know. http://ampligen-treatment.blogspot.com/2010/10/interview-with-dr-lapp-pioneer-and.html
So Sasha, don't knock Hemispherx too much - so far, they are the only biotech actively working on getting a beneficial drug approved for ME/CFS. Peterson and Lapp believe that in future trials, ampligen will be combined with anti-retrovirals - which sounds like the best hope for ME/CFS sufferers.
