Replies to post #2983 on Hemispherx BioPharma (HEB)

[otterman]

Cool:) Although I worry as Id rather have seen a leak spike even after hours or it may not have been good news. Wait, wait, wait.

[Iincognito]

If I am interpreting that correctly, does it potentially mean that the FDA has notified HEB of their decision?

[ranun]

Not sure what the elimination means

Look at the statements on page 5 which implies no notification or decision has yet been made at the time of the filing of this registration:

We filed an NDA with the FDA for treatment of CFS on October 10, 2007. On December 5, 2007 we received a Refusal to File letter from the FDA as our NDA filing was deemed “not substantially complete”. We responded to the FDA’s concerns by filing amendments to our NDA on April 25, 2008. These amendments should allow the FDA reviewers to better evaluate independently the statistical efficacy/safety conclusions of our NDA for the use of Ampligen® in treating CFS. On July 7, 2008, the FDA accepted our NDA filing for review. However, there are no assurances that upon review of the NDA that it will be approved by the FDA. On February 18, 2009, we were notified by the FDA that the originally scheduled PDUFA date of February 25, 2009 has been extended to May 25, 2009. On May 22, 2009, we were notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date of May 25, 2009.


If Ampligen® or one of our other products does not receive regulatory approval in the U.S. or elsewhere, our operations most likely will be materially adversely affected.