results to widen markets for rintatolimod. in 1998, hemispherx biopharma filed a complaint against asensio and his company, alleging defamation, conspiracy, and interference with its business relations through a short-selling plot. after a jury rejected the defamation claims against asensio, a mistrial was declared. on november 2, 1999, mary schweitzer, a cfs patient who had been treated with rintatolimod, raised the question of why ampligen has never been fast-tracked by the us public health authorities at the chronic fatigue syndrome co-ordinating committee of the u.s. department of health and human services. grassroots activism for fda approval of ampligen grew and continues. efforts in 2015 to spur fda approval of ampligen include petitions, appeal for congressional hearing, and popular social media group organizing. adam feuerstein, a journalist for the street, has published several articles harshly critical of hemispherx biopharma, inc. in june 2009, feuerstein alleged the company was "seeking to divert investors' attention away from the delayed approval of ampligen as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for ampligen as a flu vaccine booster, in which hemispherx stated that ampligen could be used against the h1n1 swine flu. this article also alleged the press releases were misleading, because they implied the research had been done in 2009. when hemispherx offered ampligen as a potential h1n1 vaccine or vaccine booster, the u.s. government turned them down, and feuerstein wrote, "hemispherx biopharma has been shut out of the u.s. government's efforts to stockpile vaccine against the h1n1 flu." research rintatolimod has been studied in humans since 1994. in early 2015, the amp 511 open-label study of rintatolimod in cfs was still recruiting participants. open-label studies are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the investigational drug until marketing approval is obtained. hemispherx management had missed several target deadlines for nda filing in the past, including the end of 2005, the third quarter of 2006, and the first quarter of 2007. in october 2007, the us fda ampligen nda was filed. in december 2009, the fda issued a complete response letter refusing hemispherx's new drug application for rintatolimod's treatment of cfs. the fda concluded that the two rcts "did not provide credible evidence of efficacy." the agency recommended a minimum of one additional six-month, 300-patient study, and rodent carcinogenicity studies. rintatolimod is administered intravenously. it is generally administered twice weekly for periods of one year or longer. two toxicology studies had been completed as of 2007, which established the safety of intranasal and intramucosal methods of ampligen administration as a vaccine immunostimulant.: 20 hemispherx has conducted research on a by mouth versions of rintatolimod using nucleic acid technology related to rintatolimod.