Replies to post #258530 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

The FDA told Elite it was okay with the TMax issue to begin with and like a government agency - a change in regime dictated a change in policy or focus. Nothing diabolic or conspiratorial IMO on the FDAs or anyone else's part. Just bad timing. It's why Elite hired Eugune Pfeifer. You deal with a problem by using one of its own that it used to protect and propel itself forward.

If you understand what Eugene did for the FDA you understand he is worth his weight in gold to Elite.

[lasers]

$ELTP is continuing with SequestOx-II (reformulated SequestOx™ ) . The FDA simply needs to find replacements for some of the 45 patients that no longer qualified and became disqualified for various personal reasons.

It is very common for a BE/Tmax trial of this large size to experience drop outs.

All 45 patients must meet the Inclusion/Exclusion criteria (1)at the beginning of the trial (2) during the trial and (3)at the end of the trial.

For those patients that have been disqualified their statistical data have been discarded by the FDA.

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 makes ALL the decisions, NOT $ELTP!

[dr_lowenstein]

yeah he thought he might get away with one. Of course, now the bullshit spin is that the FDA told him one thing then changed their mind, One SMALL problem with that BS is that there is ZERO proof