Replies to post #313464 on Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

FDA Unleash The Kraken !!!

1. SunGen ANDA #2-THE MONSTER $1.6 Billion dollar market ER CNS Stimulant with one Name Brand and 3 generic competitors. FDA filed and under review. Approval Imminent

Quote Nasrat:
“The last SunGen that was filed in May was an extended-release CNS stimulant that we co-developed with our partner SunGen. The branded and generic sales of this product are approximately $1.6 BILLION and there are currently just FOUR manufacturers which includes the branded and its authorized generics.“

2. SunGen ANDA #5 -THE GRAND DADDY OF THEM ALL Bigger than SunGen #2 also a CNS stimulant 1.6 Billion + Market +
unknown number of competitors at this time.
This is the Largest SunGen product !!!***** to date

Quote Nasrat : “We have another product (SunGen ANDA #5) that we're partnering with SunGen, that’s bigger than SunGen ANDA #2.”

Transcript for June, 15, 2018 Conference Call

https://seekingalpha.com/article/4182056-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-q4-2018-results-earnings-call-transcript?part=single

3. Reformulated Patent Pending SequestOx- THE BEAST will be the first ADF Immediate Release(IR) Opioid that will have Oral (chewing), Intranasal, and Intravenous(IV) Abuse Deterrent Labeling.
New patent to extend exclusivity
Elite will own the ADF portion of the $400 Million IR Opioid market

http://elite.irpass.com/profiles/investor/ResLibraryView.asp?ResLibraryID=86991&GoTopage=1&Category=2163&BzID=2258&t=2180&G=939

4.Unique Patent Pending Novel IR ADF-THE GOLIATH (new patent pending drug platform) which is 90% cheaper to produce than the competition

Quote Nasrat: on new ADF platform
“I am extremely excited about this formulation because it is also a platform that applies to all the IRs and its about 10% of the cost. So we're extremely excited about this, but it's still early, in the next few months once Dr. Smith files a patent and we do a few more trials, we’ll update everyone more about it. “


5.Generic ADF OxyContin-GODZILLA will the First Ever Generic ADF Opioid : Filed Sept 2017 and under review by FDA No generic competition - $2.3 Billion Dollar market

http://www.4-traders.com/ELITE-PHARMACEUTICALS-INC-19343831/news/Elite-Pharmaceuticals-Files-ANDA-for-Oxycodone-Hydrochloride-Extended-Release-25147703/

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622252.htm?utm_campaign=10022018_Statement_FDA%20Commissioner%20on%20deterring%20gaming%20of%20generic%20drug%20approval%20process&utm_medium=email&utm_source=Eloqua

“It is important to note that there are no FDA approved generic ADFs. A clear business opportunity for the well positioned firm willing to engage in a strategic investment.”


6. Isradipine -THE WILDCARD : Approved and Launched Positive Isradipine-Parkinson PH III Study ONE competitor 1 million patients
Study completed. https://clinicaltrials.gov/ct2/show/NCT02168842

Quote:
STEADY-PD III (isradipine) clinical trial results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the May 7th 2019.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141631365

https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900
7.Generic Troxyca ER Oxycodone: If FDA gives pathway to approval

https://www.in-pharmatechnologist.com/Article/2018/07/11/Elite-Pharma-Eyes-on-Troxyca-but-Pfizer-blocking-generic-release.
On hold till FDA guidance is obtained. No competition name brand abandoned

8. If the Department of Justice reduces quota of abused non-ADF opioids produced each year and increase the quota of ADF opioids.

DOJ could issue stricter limits on certain opioids (non-ADFs) if federal authorities believe they are being misused.

http://thehill.com/policy/healthcare/396566-new-regulation-gives-doj-more-power-to-limit-production-of-opioids