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Couch

03/07/15 8:51 AM

#147296 RE: John_Langston #147242

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."

NASDAQ2020

03/07/15 9:53 AM

#147299 RE: John_Langston #147242

Relisten to the CC's. Nasrat always said FDA could require one or two small studies. Guess what? 8 week Ph III is all that stands in our way. Study sites and volunteers waiting for feed back just days away.
I will continue to accumulate in the mean time.