Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

First, let’s put aside the conspiracy theories involving big pharma and the FDA and focus on the specifics we can glean from the CRL as discussed by Nasrat.

The key is to adapt and align with FDA needs. What do they need? The FDA needs to look serious about opioid abuse…and consistent with that approach they have made safety the main issue in the CRL…NOT ELITE’S ADF TECH...but patient safety; pure and simple. They have made this a safety labeling issue because it shows a seriousness in attempting to address the opioid abuse issue (you detect the irony).

So it is that, what Weezhul suggests can offer a simple fix to the problem…or an Occam’s Razor. Remember, the simplest explanation is often the best. So it is with fixing problems. I am no scientist or medical expert, but I recognize from basic statistics that to reformulate is asking for a totally new trial. Simple is best and Eugene is the guy to make the argument. Here is Weezhul’s Occam’s Razor (also known as the Law of Parsimony)…that we should hope is the basis for Eugene's argument to the FDA that is well established and often appears on prescription labels in one form or another...

SequestOx should be taken on an empty stomach. Taking less than 2 hours after eating may delay the effect. NEVER TAKE MORE THAN ONE PILL IN FOUR HOURS

REMEMBER THE POINT: SequestOx is an abuse deterrent formulation. It is to deter abuse, not patient stupidity. I would argue that even the FDA has no answers to how that can be done.