Hemispherx' Ampligen NDA delayed up to two weeks

The US drug developer Hemispherx Biopharma has been told that the Food and Drug administration may require up to two additional weeks to take  action beyond the May 25 action date on the New Drug Application for  Ampligen (Poly I Poly C12U), its selective TLR3 modulator, for the  management of chronic fatigue syndrome.

A reason for the possible delay was attributed by the Agency to certain  staff scheduling changes which might delay the report. The firm stressed  that the FDA did not request any additional information on the NDA.