 In October 2007, Hemispherx BioPharma submitted their first New Drug Application (NDA) to the FDA for rintatolimod to treat CFS.In December 2007, the agency deemed the application incomplete, citing deficiencies including lack of dose ranging, statistical analysis plans inconsistent with protocols, database discrepancies, and lack of clinical pharmacology and carcinogenicity data.In early 2009, Hemispherx again submitted rintatolimod for FDA approval for CFS treatment.