Elite Pharmaceuticals Inc (ELTP)

[Sakhi]

We all know in medical practice that absorption of almost all drugs on full stomach is delayed and Tmax will be high. This is not something peculiar to SequestOx. FDA experts, I am sure, know about this and there is nothing anyone can do to change this physiological process.

All opioids preparations are Schedule II drugs. That means one needs to have a prescription to get it. Now if someone develops acute pain, there are following two alternatives depending whether or not he has SequestOx with him.

If he has SequestOx with him, that means he has been taking the same on regular basis and his acute pain is a break-through pain due to tolerance to Opioids and requires dosage adjustment for which he should either contact his regular physician or go to ER if pain is intolerable.

If he does not have SequestOx, then he must go to ER where he will receive Opioid shot. No one is gaining to fool around with a pill in ER.

FDA waives the NDA fee and gives a priority review with a definite date. Then not approving the product on flimsy ground of high Tmax raises several unanswered questions. Is there an external force which is against SequestOx approval? I sympathies with Nasrat who has much much higher investment than all our combine investment. I am sure he must have been as much surprised on getting CRL as I was.