Elite Pharmaceuticals Inc (ELTP)

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Expected $ELTP ADT ELI200 NDA Commercial Schedule 2015-2016

Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP) announced guidance today regarding the Company's Phase III trial for ELI-200, an abuse deterrent opioid product. Elite has submitted a study protocol to the FDA and dosing for the study is expected to begin shortly after the FDA comments on the protocol are received by Elite. The Company anticipates that it will receive the FDA comments by mid-March and that dosing will take approximately eight weeks to complete.

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.

Jan 15 to Mar 15, 2015: Enroll 150 patients and finalize multi-center selection sites.

Mar 15, 2015: Receive FDA comments and finalize protocol for 150 patients with moderate to severe pain following surgery efficacy P3 clinical trial.

Apr 1, 2015: Begin double-blind 8 week dosing. 75 patients on ELI200; 75 patients on Placebo.

Jun 1, 2015: Complete dosing and begin summarizing statistics report for submittal to FDA NDA ELI200 approval.

Jul 1, 2015: Submit statistics report to FDA for NDA ELI200 approval. FDA says that $ELTP will receive FDA comments in 6 months following receipt of the ELI200 P3 statistical results.

Jul 1-Dec 30, 2015: Complete installation and testing ELI200 manufacturing equipment as well as SOPs test runs. All of ELI200 equipment, new and shared, will be totally tested with integration of $ELTP’s current ANDAs scheduling. Critical time-schedules for ELI200 and $ELTP ANDAs will be fully enacted and finalized.

Jan1 - Jan 15, 2016: Receive FDA review for expected NDA ELI200 approval.

Feb 1, 2016: Finalize NDA ELI200 1st Commercial batch in readiness for marketing sales to pharmaceutical warehouses.

Mar 1 - Mar 30, 2016: Complete NDA ELI200 shipment to pharmaceutical warehouses.

Apr 1 - Jun 30, 2016: Receive NDA ELI200 NDA revenues to be reported in $ELTP FY1Q2017 10-Q.