Hemispherx (HEB) To Widen Program for Chronic Fatigue Syndrome, Provides Update on Ampligen
Hemispherx Biopharma, Inc. (Amex: HEB) plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome.
The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time. However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009 and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
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The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time. However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009 and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
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