Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

The new bead is completed.

The meeting minutes support a plan to address the issues cited by the FDA in the July 14th Complete Response Letter by modifying the SequestOxTM formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.

They completed pivotal bioequivalence for their OxyContin ANDA within 2.5 months. Started in November, published mid January. The new bead is done, only need the supporting studies. No new HAL studies, no new Phase 3. Great news for SequestOx. New submission just a few months away.