SurgiLight, Inc. (fka SLGTQ)

[NASDAQ2020]

***** THE NEW ELITE PHARMACEUTICALS, INC (ELTP) *****

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become Abuse Resistant opiods

--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.

--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

--Doug Plassche appointed Vice President of operations to run manufacturing and to lead the operational initiatives of the Company as it expands its product pipeline. Mr. Plassche has a proven track record in all critical areas including quality, compliance, process, operations, planning and personnel development. He oversaw 450 employees previously at Activas

--cash flow positive an ELTP goal for this fiscal year(ending Mar 31, 2014)
--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*
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--12 hr oxycodone/naltrexone with 2 bead ART beginning a 6 month long 38 person trial Nov/Dec 2013 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
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--ART Oxy/Nal is a priority with Elite and further along than most people think, JT
--ELI-216 is a controlled release 24 hr NDA abuse resistant oxycodone/naltrexone requiring 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
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs (Gavis Wintac): Novel and Elite have an ongoing dialog for monetization
--Novel Labs adds to Elite's value estimates for Novel's value range from 10 to 30 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--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
--Nasarat brings 13 new ANDA drugs many requiring only CBE 30 review for transfer
--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
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--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

--Right Place at the Right Time with the Right Products Jerry Treppel
--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.

Camargo

ELTP