Monday, June 9, 2014

$ELTP Making More Incredible Progress ELI-200!!!!

If you're following the day to day action on your ticker for Elite, you are probably wondering how the pps dipped down to the mid-.30s as they are in process of advancing their product lines. It all makes for a bumpy ride. There's no easy path to the bank these days, but we will add that this stock might be tremendously undervalued. Today's news:
Elite Pharmaceuticals Begins Human Abuse Liability Studies for ELI-200 Elite Pharmaceuticals, Inc. (QB) (OTCBB:ELTP) Today : Monday 9 June 2014 Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced dosing of the first subject in the treatment phase for a human abuse liability clinical study for ELI-200. ELI-200 is an abuse deterrent product for an undisclosed opioid. The study is a randomized, double-blind, double-dummy, active and placebo-controlled five-way crossover study comparing crushed ELI-200 capsules to a comparator product. The primary objective of the study is to assess the abuse potential when administered intranasally of ground ELI-200 relative to a crushed comparator product and the secondary objectives include determining relative bioavailability and safety of the product. Completion of the dosing is expected in approximately 2 months. Final study results are expected later this year. "We are pleased to have this key study underway for ELI-200. The study is a key part of the development program for ELI-200 and we expect to file this product by year-end," said Nasrat Hakim, Elite's President and CEO. "Elite has a range of abuse deterrent products that use Elite's proprietary pharmacological abuse deterrent technology and this is one of several abuse deterrent products currently under development by Elite. Elite has completed a successful bioequivalence trial for ELI-200 earlier this year and initiated in May a bioequivalence study for a second abuse deterrent product. Our plans in 2014 include completing In Vitro Lab Abuse Studies for ELI-200 and bioequivalence studies for a third abuse deterrent product. Elite is excited to be developing these new approaches to help address the prevalent issue of prescription drug abuse." The clinical studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services. About Section 505(b)(2) The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.