Elite Pharmaceuticals Inc (ELTP)

[lasers]

FDA Pamphlet instructions, as approved for Opana IR Oxymorphone, would be as stressed in NH Jul 18 CC, applicable for SequestOx ie:

"take 1 hr before a meal or 2 hrs after a meal"

SequestOx was thoroughly proven in the 163 person Phase3 to have zero safety adverse events over the 1 week duration and +4500 capsules. The 163 persons were healthy opioid naive persons that took the SequestOx any way that was best for them, ie with a meal or without a meal, to get the best most comfortable pain relief. The Phase3 zero safety adverse events was commented on in the Jul 18 CC.

Does the FDA want a BE Tmax "Fat Meal" "arm", as $ELTP offered in 2014? If so no problem as $ELTP can quickly accommodate and commented on in the Jul 18 CC.