Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

The NEW Reformulated Patent Pending SequestOx™ is the SAFEST IR Opioid in the World.
FDA gave us guidance to make it possible.
Everyone is excited about having an IR ADF Opioid with complete ADF labeling available in the near future.
It will easily receive Oral (chewing) Abuse Deterrent Labeling like no other IR ADF Opioid has.

Here’s how it works:


FDA validated the entire ER ADF line of opioids

The FedTmax is not an issue with ER Opioids
Elite's tech can be used on all ER opioids
FDA did not find one issue with Elite 2 bead ADF except for fed Tmax which only applies to IR opioids.
Not one issue with HAL studies.


Quote:

"the FDA made no comment about Elite’s technology because it works and it’s solid. They made no comment on the human abuse liability studies because again they were solid and they work; or with the withdrawal study or the efficacy study – the Bunionectomy. This is great news for Elite’s ADT platform. There is no effect on Elite’s ER formulations"




Recent Pilot study for Re-formulated SequestOx validated entire lineup of IR ADFs Now Elite's tech can be used on all IR opioids

Pilot Study: shows a positive FedTmax for SequestOx which was the ONLY ISSUE with the IR ADF lineup.

http://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=86991&BzID=2258&g=939&Nav=0&LangID=1&s=0
ELITE PHARMA



ELTP
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Q The only issue with SequestOx™ was the FedTmax.
That was fixed months ago the PR was early this year.
See below for supporting link and exceptional results.

Quote:

“We resolved that issue and our patent attorney, Dr. Smith determined that this is something patentable and we will be filing a patent sometime next week.”


Pilot Study:

http://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=86991&BzID=2258&g=939&Nav=0&LangID=1&s=0


IR SequestOx™ will establish a New Standard of Care 2018-2019.
The most frequently abused opioids are currently immediate-release (IR) opioids.



In 2016 93% of new opiod RXs were for IR(Immediate Release) opiods.

Reformulated SequestOx™ with lowered fed Tmax is the SAFEST Immediate Release opiod in the world, and the only one using a Pharmalogical Approach to abuse deterrence.

According to data from “Do abuse deterrent opioid formulations work?” Richard C. Dart, MD, PhD; Janetta L. Iwanicki, MD; Nabarun Dasgupta, PhD; Theodore J. Cicero, PhD; Sidney H. Schnoll, MD, PhD, in the Journal of Opioid Management 13:6, November/December 2017, reported that Immediate Release (IR) opioids are 4.6 times more likely to be intentionally abused and 6.1 times more likely to be diverted than Extended Release (ER) formulations. Not surprisingly, cited in the aforementioned work is a real-world study of 300 opioid abusers entering treatment for substance abuse who indicated they prefer abusable IR opioid products because they provide faster onset of the rewarding effects.

SequestOx™ had impeccable HAL studies.



ELTP