Hemispherx BioPharma, Inc (NYSEMKT:HEB) Trading Up To New Peaks


Boston, MA – (NYSEPOST) – 03/24/2014 – The United States FDA has now released a new draft-guidance document that is intended to expedite development of the drugs to treat chronic-fatigue syndrome (also called myalgic encephalomyelitis)—this is a poorly-understood condition that has very recently been subject to very significant interest by the FDA regulators. Chronic fatigue syndrome affects patients as it causes severe, persistent & many a times debilitating fatigue. Very little is known about underlying-causes of this condition, or even about whether it is a single condition or an entire group of related conditions. In spite of the numerous theories which include the ones that have since that time been some that discredited—there aren’t any tests to determine the cause.

That leaves the patients in somewhat of a bind. Though the effects of this CFS are very real, but without any understanding of underlying causes, researchers & manufacturers are not able to target potential/ existing therapies for treating it. That bind was actually put on display & amplified in Feb 2013, when the FDA—post advice of 1 of its advisory-committee panel, didn’t recommend Hemispherx BioPharma, Inc (NYSEMKT:HEB)’s Ampligen and said that it required some additional clinical evidence & data before they could consider approval of the drug.

However, CFS patients are also the 1st to benefit from the special-provision of the FDA Safety & Innovation Act (FDASIA) that calls for the FDA to set-up its “Patient-Focused Drug Development Initiative” to take into account views of patients in a better way during its regulatory review process. In the Federal Register posting, the FDA said that the human drug & biologic review process might benefit from a much more systematic & expansive approach to obtaining any input from the patients who experience that particular disease/condition. In Oct 2012, the FDA sat down with various CFS patients to hear their views on their regulatory process, which most notably included their tolerance of risk.

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