PBR Staff Writer
Published 12 January 2012
The US Food and Drug Administration (FDA) has granted an extension for
the Hemispherx Biopharma to modify its new drug application (NDA) for
the Chronic Fatigue Syndrome (CFS) therapeutic indication.
The extension will remain open while Hemispherx submits an amended
NDA, the company said.
In the request for extension, the company advised the FDA of the
findings of a new potential companion diagnostic test for CFS.
The proof of principle study compared sequences from massively
parallel sequenced serum DNA (Deoxyribonucleic Acid) extracted from
either well vetted Hemispherx CFS sera or matching controls.
Signature DNA sequences were identified that showed statistically
significant separation of CFS serum from matching control serum.
Hemispherx medical director David Strayer said they are working
diligently to pursue approval for Ampligen as the first treatment for
Chronic Fatigue Syndrome in the US and other countries.
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