ELTP News 08/10/2014 21:15:39 $ELTP Can't call. The CC's

New Post Public Reply Private Reply Replies (0) Message Board
Jake13
ELTP News 08/10/2014 21:15:39 $ELTP
Can't call. The CC's are always held in the middle of the work day.
Since you need full disclosure, call during the CC and ask NH your question. Easy.
Quote:
the next inevitable run that will occur. My bet is the next run we blow past .97




Best of luck.
Good for us because as of now that information is not of the ELTP shareholders concern.
All speculatives and few facts = .30; still overvalued.
Thanks. My entire net worth is already in this.
He may have a law degree but that does not make him a lawyer.
Thank God someone is.
Another student loan
QUESTION: Is ELTP a Good Investment going forward?
ANSWER: Check out this list of facts (compiled by NASDAQ):

*****
--no more going concern, bond debt current
--strongest balance sheet in Elite's history
--first working capital surplus in 5 years

--The Company’s primary focus has become the accelerated development of their complete line of Abuse Resistant opiods
--Elite's goal is to become the leader in the ART/ADT opiod market "no one will stop us" "we are going to market" CEO
--"We have set in motion several initiatives that will have significant impact on Elite's future" CEO
--aggressive schedule with clinical trials, quadrupling of R&D costs, working on *5-6 ART opiods* concurrently in 2014,
one or two ART/ADT opiods will be filed with FDA in 2014 if fast track status granted
--the longer we go without partnering the high the value of the company
--$40 MILLION in funds secured from LPC(Lincoln Park Capital) to develop ADT/ART products with or without a partner
--$5 MILLION more recieved from sale of Elite's 9.99% ownership in Novel Laboratories 06/10/2014
--Multiple potential partners are approaching ELTP and are waiting on trial results. 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
--completed SUCCESSFUL pivotal bioequivalence studies on both ELI-201(twice day oxy ADT) and ELI-200(undisclosed twice a day)
ADT opiod) Abuse studies for ELI-200 underway
--Generic Business Cash Flow Positive minus R&D costs for last two quarters, approaching 2+ million in revenues per quarter

--Poison Pill 8-A12G filed and a staggerd Board of Directors in place protects shareholders from a hostle take over, independent analyst determined the value of Elite is undervalued and its true value is between $2.10 and $2.75 as of late 2013
--Nasrat Hakim, Elite's President and Chief Executive Officer has provided an unsecured line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of ART product development activities.
--Board member Jerry Trepple loand $600,000 unsecured took repayment of his loan in preferred I shares
--Billion dollar pipeline-33+ DRUGS including a complete line of 17 NDA and ANDA abuse resistant (ART) opiods plus multiple generics


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%
Compare Q3'14 vs Q3'13 Revenue increased +154%
Q4'14 ended the year off with the BEST year for earnings EVER for ELITE

--20 FDA approved drugs: 8 launched and gaining market share: 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 who will manufacture 11 of the 12 approved generics ANDAs 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. Isradipine CBE-30 filed by Elite and will be manufactured by Elite and only has 1 competitor in a 6 million dollar market. EPIC will file CBE-30 for the second MIKAH ANDA Dantrolene in June 2014, it has one competitor in a 12 million dollar market

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for multiple 12 hr ART generic and NDA opiods where Bio-equivalency studies alone are enough
trial #1 mega pilot 4 way cross over on 64 subjects SUCCESSFUL on 12 hr Oxy/Nal ELI-201 completed in 2013
trial #2 and 3 pivotal BE studies SUCCESSFUL for both ELI-201 (12hr oxy) and ELI-200 (12hr undisclosed) ADT
trial #4 and #5 Started 05-19 for ELI-202:the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-202, an undisclosed opioid abuse deterrent product, utilizing Elite's proprietary pharmacological abuse deterrent technology. Two bioequivalence studies will be run together for ELI-202.
2014 Lifetree 3 tier abuse deterrent studies to obtain * FDA ADT LABELING *
a) snorting trial
b) oral abuse
c) IV abuse
Additional Human Abuse Liability Study started June 2014 to test abuse potential of crushed ELI-200 taken intranasally
ELI-200 believed to be morphine/naltrexone(a better Embeda) is also on schedule for a Dec 2014 FDA filing
trial #5 June/July 2014 ONCE/DAY 24 hr ELI-216 ** $$ will eventually be the ONLY 24 hr oxy in the USA $$ **
this one product may need a Phase III trial, FDA to decide after BE's
--ELI-154 CR (once a day Oxy) in scale up for Large European Market

--CEO owns 23% of co. and has challenged team to get the First 12 hr ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7 Billion dollar market*******, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--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

--Barbara Ellison has been given the position of VP Quality Control Operations & Regulatory Affairs: Barbara will oversee the regulatory and quality functions for Elite and will play a key role for the Company as it expands the product development and commercialization of the Company's opioid abuse deterrent products. Her role was created to support the abuse deterrent product filings, the first of which is planned for THIS year. She also be an important contributor as Elite files additional products and launches our first abuse deterrent product. Her national and international expertise in quality management and regulatory affairs will richly support Elite's compliance and quality goals.

--FDA likes the pharmalogical approach to abuse resistance FDA being very positive
--the ART is rock solid, innovative, superior and he has not seen a better ART CEO
--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
--3rd ART Hammerlock patent 8,703,186 April 2014
--**Canadian Patent Number 2,521,655 titled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof”. Issuance 03/2014 expands the scope and reach of Elite’s patent estate internationally. Elite has additional patents pending in the U.S., Canada and Europe.
--Additional European and Canadian Patents Pending
--Elites ART is modular, it can be used on ALL opiods just add a different opiod bead to the naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--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.
--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 Woodcock & Baker 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

--CEO and officers being paid with stock
--multiple partners 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 $500,000 invested in faclity in 2014, new encapsulator, tablet press and high shear grandulator
--NEW packaging line operational
--39 employees over double of two years ago
--CEO wants to get a $50 million/ yr ANDA per shareholder meeting 2014
--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
--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 17 abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Once the pilot and pivotal studies completed in March 2014 CEO to go on the road to present the results to viable partners
--Elite will be attending Rodman Renshaw conference again in Sept 2014
http://seekingalpha.com/article/1688112-elite...urce=yahoo
http://seekingalpha.com/article/1905051-elite...the-fences
http://seekingalpha.com/instablog/4199131-cou...ain-killer

--500 series I convertible stocks created (02/07/14) with a value of 50 million dollars. 105 were used to pay off CEO's drug transfer and Trepple's unsecured loans, 395 available IF NEEDED at a to be determined share conversion price, these can also be used for financing and leverage for a favorable deal for shareholers

--Partner Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission
--Important FDA meeting coming up in August 2014



ELTP


"We have emerged as one of the leaders in the development of abuse deterrent opioids"

LMAO; we need to stick to the fundamentals. LOL
Correct, Nasrat is not a Lawyer ...


IB_
Another great point and post.
He is not a lawyer. He is the CEO of Elite.
He's a lawyer. It's a fact.
How does he have the time to be CEO of Elite if he's a lawyer???

So that's what the PPS is so low. He spends all his time in his law office and just 30 minutes per day at Elite.
Another awesome post; the others make buying above 0.35 sound like we are paying too much for ELTP.
So who does everyone think the two top companies Nasrat gets to choose for a partnership are?

Pfizer? Purdue? J&J? Merck?
Sorry but I bought at .06 and am buying below .35.
Sure he is. Nasrat's a lawyer. Notice the lack of question mark.
Scroll down for more posts ▼

Top 10 Most Recent News Articles

Quantum Space Joins $185M NASA Lunar Transport Deal

Updated Category News Views 347

Quantum Space Bags a Chunk of NASA's Lunar Ambitions Alright, folks, buckle up because we're about to dive into the cosmos. Quantum Space just nabbed a sweet deal—a $185 million whopper of a contract from NASA's Moon Base Transportation program. This isn't chump change; it's a 25% slice for Quantum from the lot Arrow Science and Technology is heading. We're talking...

Continue Reading
NatGold Pulling NATG From MEXC Amid Security Concerns

Updated Category News Views 427

NatGold Digital's sudden decision to yank its NATG token off MEXC Global reeks of regulatory urgency. With the U.S. Treasury clamping down on fund transfers wrapping up MEXC in their action against Russian laundering, NatGold didn't wait for the ink to dry on that order. They’re off the exchange posthaste. A bit of foresight or sheer necessity? Well, it's got the market...

Continue Reading
Evaluating GLP-1 Telehealth? Key Questions to Consider

Updated Category News Views 451

Navigating the Landscape of GLP-1 Telehealth Providers In the sprawling jungle of telehealth options for GLP-1 care, it's easy to feel like you're drowning in sameness. Picture this: you land on a sleek page promising the moon and stars, but who knows what's behind the curtain? That's where seasoned advice comes in, like a compass in this murky digital forest. Meant, a...

Continue Reading
2027 Toy of the Year Finalists Energize Play Market

Updated Category News Views 272

A Kaleidoscope of Innovation in Toys There's a familiar buzz in the air, folks. The 2027 Toy of the Year Awards finalists have been unveiled, and they're bringing a fresh wave of creativity to children's playrooms. These aren't just toys; they're miniature innovators ready to light up the market this holiday season. The reveal happened at the Chicago Toy & Game Fair and...

Continue Reading
Paris Baguette Pioneers Drive-Thru in Oklahoma

Updated Category News Views 468

Tapping The Unseen Potential In Bakery Cafes Every so often a business move comes along that makes you sit up and say, "Why the hell haven't they done this before?" Paris Baguette has finally cracked that code, rolling out its first-ever drive-thru in Moore, Oklahoma. Now, imagine yourself zipping through for a croissant without leaving the comfort of your car seat. Makes...

Continue Reading
Intelligent Communication Forum Eyes Global Ecosystem Shift

Updated Category News Views 89

China's Grand Vision for Intelligent Communication You know what they say about big ideas—they start in the most bustling of places. And here we are in Wuxi, a city's pulse pounding with ambition, hosting the 2026 China International Intelligent Communication Forum. Picture it: From November 8th to 10th, movers, shakers, and visionaries are scribbling new blueprints for...

Continue Reading
Adding Fireplaces: Home Comfort or Construction Headache?

Updated Category News Views 276

Sizing Up the Installation Options Slapping a fireplace into a home sounds more like a pipe dream than a practical project for most folks. But according to fireplace whiz Jimmy Smith down in North Charleston, the times are a-changin'. These days, with advances in technology, homeowners can actually pull it off without collapsing their living room walls. Nitty-Gritty:...

Continue Reading
FuelCell Faces Class Action Crunch as Deadline Looms

Updated Category News Views 192

FuelCell's Legal Storm: What to Know Now You ever get that feeling when your gut knows it all before you even finish reading the headline? Well, buckle up, because FuelCell Energy, Inc. (NASDAQ:FCEL) is staring down a potential class-action train wreck, and they ain't got much track left to skid on before the deadline hits hard on November 10th, 2026. The Crunchy Details...

Continue Reading
J&J's New Study: Sjögren’s Solution Insight Sparks Debate

Updated Category News Views 174

Patient-Centric Take on Sjögren's Disease Johnson & Johnson has dropped fresh Phase 2 results on nipocalimab, reminding everyone they're at the helm of reshaping treatments for Sjögren's disease (SjD). A condition leaving about four million folks craving better days, in multiple ways, shines a light on what's gripping patients the hardest. It's hard not to sit up and...

Continue Reading
Boston STEM Expo Sparks Young Minds in Engineering

Updated Category News Views 184

If you really want to light up a kid's imagination, throw them into a room full of science experiments and let 'em have at it. That's exactly what happened at the recent Society of Women Engineers' Innovation Expo in Boston's Seaport District. The place was buzzing, and not just because of all the engineering gadgets on display—it was the energy of young minds...

Continue Reading

Top 5 Most Recently Viewed Articles

Bio-Thera and Tabuk Join Forces for BAT2206 Biosimilar Launch

Updated Category News Views 136

Bio-Thera Solutions Partners with Tabuk Pharmaceuticals Bio-Thera Solutions Inc. (688177:SH) has announced a significant partnership with Tabuk Pharmaceutical Manufacturing Company, a respected player in the pharmaceutical industry. This collaboration marks a new chapter in the commercialization of BAT2206, a proposed biosimilar to Jansen's Stelara. Understanding BAT2206...

Continue Reading
Unlocking Innovative Trading Solutions with XploraDEX's $XPL

Updated Category News Views 381

XploraDEX: Transforming Trading on the XRP Ledger XploraDEX is on a mission to revolutionize the trading landscape on the XRP Ledger by implementing an intelligent, adaptive decentralized finance (DeFi) infrastructure. With the XRP ecosystem recognized for its remarkable speed and efficiency, many traders have long sought advanced solutions to fully harness its potential....

Continue Reading
Ferrari N.V. Updates on Share Buyback Program Progress

Updated Category News Views 89

Share Buyback Program at a Glance Ferrari N.V. (NYSE/EXM: RACE) has provided an update on its ongoing share buyback program. Launched in 2022 with a total budget of approximately Euro 2 billion, the program is unfolding in tranches designed to support a disciplined capital structure and steady shareholder returns. The continued rollout underscores Ferrari’s intent to...

Continue Reading
Global Ship Lease Announces Generous Dividend for Investors

Updated Category News Views 148

Global Ship Lease Declares Significant Dividend In a noteworthy announcement, Global Ship Lease, Inc. (NYSE:GSL) recently disclosed that its Board of Directors has approved a cash dividend of $0.546875 for each depositary share. Each depositary share represents a 1/100th interest in a share of the Company’s 8.75% Series B Cumulative Redeemable Perpetual Preferred...

Continue Reading
iBio Inc. Showcases Innovative Antibody Developments Soon

Updated Category News Views 194

Exciting Presentations from iBio Inc. iBio, Inc. (NASDAQ: IBIO), a pioneering biotechnology company, is gearing up to present breakthrough research on its Activin E antibody. This development showcases its commitment to addressing critical health challenges like obesity. Recently, Cory Schwartz, Ph.D., the Director of Research and Early Development at iBio, announced his...

Continue Reading