Hemispherx BioPharma (HEB)

[NickPar]

Company Highlights up to Dr. Carter's recent interview

http://www.istockanalyst.com/article/viewarticlepaged/articleid/3546991/pageid/1


On 7/7/08, the FDA accepted for review Hemispherx Biopharma's (AMEX: HEB: 1.83, 0.05) ($1.81) NDA for Ampligen to treat chronic fatigue syndrome (CFS), which was originally submitted in October 2007. The NDA for Ampligen (poly I : poly C12U) is also the first ever accepted for review by the FDA for systemic use of a toll-like receptor therapy to treat any condition and there are currently no FDA-approved treatments for CFS. On 2/18/09, HEB was notified by the FDA that the originally scheduled PDUFA action date was extended by three months to 5/25/09. On 5/22/09, HEB was notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date. However, since that date, no further notification has been received from the FDA.

On 10/9/09, BioMedReports.com conducted an interview with HEB's CEO, Dr. William Carter for an update on the Ampligen NDA status. Dr. Carter stated that HEB expects to complete a set of preclinical toxicology reports during 4Q09. In addition, the Agency has conducted inspections of manufacturing facilities over the past 12 months which required no corrective actions by HEB. However, the FDA noted certain compliance issues with "fill and finish" facilities and took corrective actions with its own facilities in NJ and is about to complete remediation actions in the next several weeks in the contract lab in WA with a report to the FDA pending. In addition, animal toxicology studies conducted by Lovelace Respiratory Research Institute in NM in support of the Ampligen NDA and at the request of the FDA are currently undergoing auditing and expected to be completed by late 2009 to early 2010.


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