Elite Pharmaceuticals Inc (ELTP)

[lasers]

Either way $ELTP FDA Tmax Trial data results will be Jul 2017

NORTHVALE, N.J., May 25, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), today announced that top-line results for its reformulated SequestOx™ study are expected in July 2017. Patient disqualification and subsequesnt subject recruitment issues extended the completion date for the study. The study, which began in March 2017, is a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx™ and to a comparator product under fed conditions. The reformulated product is expected to have a shorter Tmax than the original SequestOx™ formulation under fed conditions. SequestOx™ is Elite's investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The FDA is 100% in charge of $ELTP's official study and whatever the FDA decided dictates the number of qualified recruits required to complete the study. $ELTP has no say in this matter or any other matter for the study.