Elite Pharmaceuticals Inc (ELTP)

[Couch]

It's a secret, not even the FDA knows.

LMAO uh sure Ok.

The Phase III study is a multi-center, randomized, multiple-dose, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study will enroll approximately 150 patients. We anticipate filing the ELI-200 NDA in Q3 and therefore expect the NDA review by FDA to be completed by early 2016.

Two additional studies will also be completed to support product labeling. The first study is a Phase I, open-label, randomized, single-dose, three-way crossover study to compare the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers. Dosing of this study has been completed. The second study is a randomized, double-blind, multiple-dose, parallel group study to evaluate the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects. The dosing of the withdrawal study has been initiated. Results and reports for both studies are expected to be available prior to the completion of the Phase III study.

"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."