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ELTP > SEC Filings for ELTP > Form 8-K on 23-Aug-2013All Recent SEC Filings

Show all filings for ELITE PHARMACEUTICALS INC /NV/ | Request a Trial to NEW EDGAR Online Pro

Form 8-K for ELITE PHARMACEUTICALS INC /NV/


23-Aug-2013

Entry into a Material Definitive Agreement


Item 1.01. Entry into a Material Definitive Agreement.

On August 19, 2013, Elite Pharmaceuticals, Inc. ("Elite" or the "Company") executed a Master Services Agreement ("Agreement") with Camargo Pharmaceutical Services, LLC (""Camargo"). Under the Agreement, Camargo will provide various services to assist Elite with the U. S. Food and Drug Administration 505(b)(2) regulatory pathway for the products utilizing the Company's abuse resistant technology. Elite is scheduled to begin clinical studies with the initial product later this year.

A 505(b)(2) is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method is a holistic approach for developing products that offer differentiated benefits and gains approval for new drugs in a fraction of the time and cost required by traditional paths. Conducting clinical trials does not assure a successful outcome or FDA approval.

Camargo is a full-service drug development partner specializing in the 505(b)(2) process - an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.

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