Just found this the source is pretty solid as she was at the hearing. This does not bode well darn it.
This statement is what stood out.
"allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission." As many of you know I have been a strong supporter of a chance for HEB to step up. But the question is can they. will they. I wonder if they even have the resources to step up.
Feb 04, 2013
Hemispherx announces receipt of a Complete Response letter for Ampligen to treat CFS
Q: Why did Ampligen receive another Complete Response (CR) letter?
A: On February 4, 2013, Hemispherx announced the receipt of a CR letter from the FDA for Ampligen. FDA issues a CR letter to convey that our review of an application is complete and we cannot approve the application in its present form. A CR letter describes all of the specific deficiencies that the Agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission. Because the NDA for Ampligen is not approved, FDA cannot provide information or comment about what was contained in the CR letter unless Hemispherx makes that information public.
Q: What treatment options are currently available to treat ME/CFS?
A: There are currently no FDA approved treatment options for ME/CFS. According to the CDC, managing chronic fatigue syndrome can be as complex as the illness itself. There is no cure, and symptoms can vary over time. Thus, people with CFS should closely monitor their health and let their doctor know of any changes; and doctors should regularly monitor their patients' conditions and change treatment strategies as needed.
Q: Where can I get more information on Ampligen?
A: Please contact Hemispherx for more information.
Q: Does FDA consider ME/CFS to be a serious disease and what is FDA doing to aid those suffering from this disease?
A: Yes. FDA considers ME/CFS to be a serious disease and we are and will continue to be active participants in the search for effective therapies for persons with ME/CFS. The CR letter issued for Ampligen is entirely separate from FDA's support of drug development pathways for CFS.
In support of the ME/CFS community’s needs, FDA is an active member of the Chronic Fatigue Syndrome Advisory Committee, which provides advice and recommendations to the Secretary of Health and Human Services (HHS) on issues related to ME/CFC. In 2012, FDA held a stakeholder teleconference and a November webinar titled “Myalgic Encephalomyelitis and Chronic Fatigue Syndrome: Working Together for Change.” Future plans include an FDA sponsored workshop in spring 2013 focused specifically on ME/CFS drug development.
FDA encourages the pharmaceutical industry to continue to look for new treatments in this area.
