Sorry more misinformation. It was never promised and what was stated is if the FDA required an efficacy trial Elite would perform one. Well guess what.
"We are pleased with the guidance we have received from the FDA and the clear regulatory pathway forward for ELI-200. Our filing date is expected to be in the third quarter of this year, and we are encouraged that the FDA review leading to approval is expected to be completed by early 2016," said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "In preparation for the launch of ELI-200, we are also expanding our manufacturing facility and adding capacity. ELI-200 is the first of our abuse-deterrent opioid pipeline of products under development utilizing our proprietary technology platform."