Elite Pharmaceuticals Inc (ELTP)

[lasers]

So, with SequestOx taking a little over an hour longer than Roxicodone to reach peak serum concentration, there is theoretically an increased potential for overdose between one and the other.

What this does mean is that it’s an added risk factor. What it doesn’t mean is that SequestOX is too dangerous to pick up an approval in its target indication. Markets seem to be assuming that the latter of these implications is correct as opposed to the former and therein (for us) lies the opportunity.

Sure, a comparable Tmax would be great, or a shorter Tmax even better. However, these are complex drugs (with the abuse deterrence side of the equation accounting for a large portion of the complexity, which of course, the comparator doesn’t have) and that it has a slightly longer Tmax (somewhere in the region of 25%) isn’t overly surprising.

It’s also not damning for the program. A fatty food risk is something labeling can easily resolve and something that labeling has easily resolved on hundreds of other drugs that are readily available in the US today.

https://insiderfinancial.com/caution-dont-misinterpret-the-elite-pharmaceuticals-inc-otcmktseltp-data/138438/

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All of the Oxymorphones of +60 FDA approved drugs, IR and ER, NDAs and ANDAs, all have the FDA approved Pamphlet instructions to take on an empty stomach.

"One hr before a meal or two hrs after a meal"