Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

DD Made Easy

****Read the Company's website, look at what has come before Nasrat became CEO, understand who Nasrat is and where he came from, read the company's PR's and SEC filings, and listen to the various presentations the company has been a part of. I'll provide just a few. The learning curve is steep but if it is worth the going it is worth the travel.

http://www.elitepharma.com
http://www.elitepharma.com/management-key-employees/
http://b2icontent.irpass.cc/2258/166192.pdf?AWSAccessKeyId=1Y51NDPSZK99KT3F8VG2&Expires=1472651949&Signature=W9GdXe0A2wmlLSkp6Nr6M%2BiMahk%3D
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingHTML1?SessionID=JXpSe3-0bA5lo-9&ID=11534435
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingHTML1?SessionID=JXpSe3-0bA5lo-9&ID=11497617

After this light reading, a few thoughts will be presented with FACTS/LINKS on the present backdrop of Elite and why investors believe this is a great company to invest in.

1) There are ZERO IR ADT opioids on the market with an ORAL ADT label. ZERO
This represents a HUGE market for Elite both in relation to SequestOx but also in relation to Elite's ADT generic pipeline. More on this later.

http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm514939.htm

Quote:
There are currently NO immediate-release with FDA-approved AD with ORAL labeling consistent with the 2015 guidance for industry, “Abuse-Deterrent Opioids — Evaluation and Labeling.” There also are no currently approved generic versions of opioids with approved AD labeling. Elite has filed for a Generic ADF OxyContin


2) The FDA is pushing for all opioids to one day be abuse deterrent opioids.

Abuse-Deterrent Opioids: What You Need to Know

http://www.medscape.com/viewarticle/867679_2

Quote:
The FDA looks forward to the day, hopefully soon, when most opioids in the United States are marketed in abuse-deterrent forms. To facilitate an open dialogue on this important issue, and to obtain clinical and scientific input from outside experts, the FDA plans to hold a public meeting in November to discuss issues related to the development and evaluation of abuse-deterrent technologies, particularly for generic drugs


3) 90% of all opioids prescribed are immediate release opioids. Notice the head of the FDA has also stated that he hopes one day all opioids are abuse deterrent opioids. Further, the FDA has become more serious about thwarting abuse of opioids part of doing so is pushing the development of ADT opioids such as Elite's phramacologic approach. You might also notice that 90% of all opioids prescribed are immediate release but also that 90% of all opioids that are prescribed are generic brands. To move forward there are also zero ADT generic drugs on the market.

FDA requires 'black box' warning on painkillers

http://www.cnn.com/2016/03/22/health/fda-opioid-black-box-warning/

Quote:
Califf said he hoped that all opioids would eventually be abuse-deterrent versions, but he cautioned that there's still research needed about how effective they are in the real world.



4) In March of 2016, the FDA came out with required labeling changes for Immediate Release opioids including additional warnings and safety information that are expected to be incorporated.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm
Unfortunately, Elite's SequestOx's NDA was already filed with the FDA or Elite would've been able to receive additional guidance from the FDA on how to incorporate these changes. This highlights how a change in policy though well intentioned can have adverse effects or a ripple effect in the industry on specific companies prior to the new changes being put in place. IMO Elite was a company caught in the aftermath of this focus by the FDA on immediate release drugs. For instance, the TMax issue was previously seen as a labeling issue by the FDA then became a safety issue that all immediate release products have.


Quote:
Guidance for Industry
Food-Effect Bioavailability and Fed Bioequivalence Studies


http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf



5) Just to reiterate Elite's ADT can be applied to IR drugs - again which no IR drug on the market has captured an ORAL ADT label....SequestOx could be the first and only....and Elite's ADT can be applied to generic drugs -- of which there are ZERO generic drugs on the market that contain ADT period. (Elite currently has a generic ADF filed with FDA)

7) Elite has the ability to RIDE the GENERIC train via PFIZER - these Elite products will be the GENERIC and NDA's related to PFE's Embeda and Troxyca - AS NASRAT has stated Elite will save 30/70 million dollars in trials on Troxyca alone.

8) Nasrat has reformulated SequestOx with an acceptable fedTmax and his chances for approval are solid -

Quote:
The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration's (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%. - See more at: www.raps.org/focus-online/news/news-article-view/article/1138/bio-analysis-resubmissions-after-third-round-of-fda-review-not-worth-the-effort.aspx#sthash.ITXRWAim.dpuf


http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM437431.pdf


http://seekingalpha.com/article/3999933-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2017-results-earnings-call-transcript?part=single

Elite Pharmaceuticals, Inc. reported positive topline results from a pilot study conducted for SequestOx™, Elite's immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. An objective of the study was to assess whether the reformulated SequestOx could achieve a Tmax (the mean or median time to the maximum drug concentration in subjects) comparable to the reference drug, Roxicodone, when dosed with the standard high fat meal specified by the FDA. As opposed to the earlier formulation, based on these pilot results, the modified SequestOx™ is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA.


IMS reports approximately $400 million annually in revenue for the immediate release oxycodone generic market. There is currently one other approved, but not yet commercialized, abuse-deterrent product and many non-abuse deterrent generic products in this market. Immediate release oxycodone is one of the most highly abused opioids in the U.S.


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