This drug has been in the pipeline at least ten years. The FDA and cdc are a bunch of Keystone cops paid off by big pharma. If the FDA had its way Penicillin wouldn't have been available until the 1950s. This drug could potentially have extended the lives of over 1 billion people in those lost ten years. Pity the poor overworked and under appreciated FDA. Those people had to die for the sake of scientific purity otherwise the anarchists would rule the world.