HEB..$.475 Hemispherx Biopharma: FDA accepts complete response submission regarding the Ampligen New Drug Application for chronic fatigue syndrome (HEB) 0.44 : Co filed on July 31, 2012 with the FDA its complete response to the FDA's November 25, 2009 Complete Response Letter in support of Ampligen's New Drug Application for Chronic Fatigue Syndrome. On August 10, 2012, the FDA acknowledged in writing receipt of the Company's August 1, 2012, response stating, "We consider this a complete, class 2 response to our November 25, 2009, action letter. Therefore, the user fee goal date (PDUFA) is February 2, 2013."
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.