Hemispherx submits answers to 14 FDA questions regarding approval of Ampligen

PHILADELPHIA Hemispherx Biopharma, which develops new drug entities for treatment of seriously debilitating disorders, announced Wednesday that it has formally submitted to the Food and Drug Administration detailed responses to all of the 14 questions posed by the FDA concerning the company’s application for Ampligen, an experimental therapeutic to treat chronic fatigue syndrome, according to reports.

On Dec. 15, Hemispherx received the questions from the FDA, at which point the application was deemed by the FDA as “not sufficiently complete” to permit substantive review. The questions spanned a range of clinical and preclinical topics.

Ampligen represents an entirely new class of RNA-based drug therapies. The company’s prompt response to the questions posed by the FDA was made possible by the broad-based team of clinical and scientific experts assembled during 2007, with experience in successful global development of NDAs for new molecular entities, Hemispherx reported.