Replies to post #78832 on Elite Pharmaceuticals Inc (ELTP)

[KoKid3g1]

Fact:

Nasrat became CEO as well as transfering over a dozen drugs that is free of cost, (ofcourcse this cost is paid 3 years from now).

Fact:

EPIC extended the alliance deal.

Fact:

EPIC is taking on all costs with the transfer of Nasrats's drugs.

Fact:

Human trials start December 5th

Fact:

Epic is selling *some* shares to pay the milestone payments.

Fact:

Form 4s were placed near the same time of the CC this week by Epic. One milestone payment has alrdy been paid and one is on the way.

Opinion:

The above are all facts that I call real DD and not me speculating if MM's, or flipper's, or shorters, or "the poison pill" has anything to do with the PPS.

Also opinion:

The poison pill has nothing to do with the 6 million shares traded yesterday. Nasrat explained what it is used for as well I just posted you the “facts” of what a poison pill is used for.

Correct ! Opinions are allowed and carry weight, but opinions followed by facts usually carry more.

[NASDAQ2020]

- the development of our abuse resistant technology has been greatly accelerated, aggressive schedule with clinical trials starting Dec 5, 2013.
--"We have set in motion several initiatives that will have significant impact on Elite's future" NH
--averaging 1 million + in revenues per quarter
--Generic Business Cash Flow Positive minus R&D costs for ART opiods
--R&D cost have quadrupled
--Revenues Increase by 83%
--large milestone payment from EPIC paid Nov 15, 2013
--no over due orders
--inventory $ 1.7 million
--Poison Pill 8-A12G filled to protect shareholders from a hostle take over of Elite
--Moving forward with ELI-154 (once a day Oxy) for Large European Market scale up

--Billion dollar pipeline-33 DRUGS plus a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg ' Elite has signed a Manufacturing and License Agreement with Epic Pharma
which will have the right to manufacture, market and sell the 12 approved generics recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products utilizing their patented proprietary technology. 2-3 of the best transferred ANDAs with minimal competion will be launched in 2014

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--8 launched drugs continue to gain market share
--Nasrat Hakim, Elite's President and Chief Executive Officer. Pursuant to this agreement, Mr. Hakim has agreed to provide to Elite a line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of product development activities.
--Board member Jerry Trepple loaned the co. 1 million dollars unsecured $600k used so far may take stock as repayment of loan
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY*

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--CAMARGO helping with 505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough are now priority one
--12 hr oxycodone/naltrexone with 2 bead ART Trials initiated
--Clinical trial #1 Dec 05, 2013 4 way cross over Elite going it alone without partner on 12 hr oxy
trial #2 Jan 10, 2014 pivotal 52 person
trial #3 Early March 2014
trial #4 Mar/April 2014 ====$$ Second ART Product $$ for "once" a day (24hr)Oxy====
--will be working 3 known ART opiods concurrently in 2014 possibly more undisclosed
==CEO has challenged team to get the First ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7-3.0 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which will only have to demonstrate bioequivalence to the twice a day formula, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--ELI-216 is a controlled release 12 and 24hr NDA abuse resistant oxycodone/naltrexone 24 hr version requires Phase III clinical trials
--Multiple potential partners are approaching ELTP and are waiting for human data gathered (multiple short studies required) then discuss results with FDA. CEO wants to license ART "after studies and trials completed" making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection pending
--Elites ART is modular, not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies Nov/Dec
2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies

--CEO and officers being paid with stock
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational
--30 employees double of two years ago
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development on the back burner
--HITK's intermediate for a generic of a branded 100 million dollar market= drug Lots produced
--first of 8 Epic drugs(Stategic Epic Alliance) ISRAPIDINE has been filed with the FDA ONLY ONE COMPETITOR
--Naltrexone 50mg launched Sept 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation http://www.earningsimpact.com/Transcript/83582/ELTP/Elite-Pharmaceuticals---Rodman-and-Renshaw-Annual-Global-Investment-Conference/Page/1#sthash.QxtYt3CJ.dpbs and several Seeking Alpha articles
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo

--On September 10, 2012, Epic Investments exercised the remaining Series E Convertible Preferred Stock. Pursuant to the terms of the Series E Convertible Preferred Stock, 65,843,621 shares of common stock were issued to Epic Investments upon the conversion.


Compare Q2'13 vs Q2'12 Revenue increased +131%
Compare Q3'13 vs Q3'12 Revenue increased +30%
Compare Q4'13 vs Q4'12 Revenue increased +134%
Compare Q1'14 vs Q1'13 Revenue increased +27%
Compare Q2'14 vs Q2'13 Revenue increased +83%

Revenues from Manufacturing: Q2 '14 $921k!!!