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**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call are typically allowed to ask 1 or 2 questions following the company's prepared statements.
To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Please explain the purpose for the upcoming meeting in October with the FDA. Best case and worst case scenario.
3. With so much going on will Analyst be reassess-updating last Falls value of Elite for future negotiations?
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
7. 2 FDA applications ... what info can we get? How long have they been in the system?
8. 11 ANDA's for site transfer, what's going on?
9. Any plans for Eli-154?
10. What's the next step for Eli-201?
11. What's going on with the three drugs in Scale up?
12. Any generics moving up the ladder to commercialization?
13. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
13. In July, the FDA approved Purdue's Targiniq ER with labeling describing the product's abuse-deterrent properties. Is ELTP's ART more effective than Purdue's? If so, is it likely that the FDA will also approve ELTP's ART products?
14. ELTP has been severely criticized by some people for not revealing the name of the independent analyst who valued ELTP from .40(worst case) to 2.75 (best case). Can you please tell us the analyst's name (or at least tell us why you won't tell us)?
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 3 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
--Six quarters in a row of increasing revenues:
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%
2014 BEST REVENUES in company's history
--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-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swing for-the-fences
http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-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
'skichic'--what is your take on prospects for this company within the next 12 months? and/or beyond that time-frame?
Actually, i had high hopes at the time i foolishly bought in here at .05. Considering they own some companies, they do have some assets.
The new CTO--although highly annoying--did apparently ply an important role in bringing success to other companies where she was previously employed.
We can only hope...
'Mocha Jet', Great Idea--to create a question list for the Conference Call as you did before.
As you said: "The idea being that since each caller is given an opportunity to ask one or two questions... Having a central list of questions available for all to reference would insure most, if not all, questions could get asked". Thanks in advance.
Conference call questions--Are questions ever taken that have been emailed to Dianne in advance?
1. How do you know the study hasn't started?
2. there are often delays in bio-tech/pharma beyond control of the CEO.
We all know that NH wants to get all 17 of the ADTs done as quickly as possible.
What exactly is this alleged "lie"? and provide a link please. Otherwise it's just your fantasy.
Quote: "just hope loyal longs are holding not flipping at this point." Many--perhaps most--loyal longs are continuing to buy at this point, with whatever dollars and cents they can come up with from behind the sofa or anywhere else!!!
The long list of remarkable achievements and solid facts about ELTP (compiled by Nasdaq, re-posted by me) was described by 'richme' as "all speculatives and few facts".
In making that CLEARLY FALSE STATEMENT, richme completely blew his cover and revealed his true agenda! Only someone with an agenda to mislead and misinform--trying to implant doubts in worried minds--could make such a statement.
HERE, ONCE AGAIN, IS THE LIST OF SOLID ACHIEVEMENTS AND FACTS ABOUT ELTP that all investors should remember and refer to often--especially if any wayward doubts creep into your mind. Perhaps paste it on your refrigerator.
There is no speculation here, only solid facts. See for yourself:
***** ELITE PHARMACEUTICALS, INC (ELTP) *****
--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-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swingfor-the-fences
http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-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
"We have emerged as one of the leaders in the development of abuse deterrent opioids"
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
HERE, ALSO IS THE AMAZING BIO OF OUR CEO, MR. NASRAT HAKIM (first posted by Mocha Jet)
Businessweek.com
http://investing.businessweek.com/research/stocks/people/person.asp?personId=35746834&ticker=ELTP
Mr. Nasrat Hakim has been the Chief Executive Officer and President of Elite Pharmaceuticals, Inc. since August 1, 2013. Mr. Hakim has more than 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He has a 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 served as a Vice President of Quality Compliance and Technical Services at Actavis LLC. Mr. Hakim served as Vice President of Quality of Alexza Pharmaceuticals Inc. since July 18, 2007. Mr. Hakim served as Corporate Vice President of Quality and Compliance for Actavis / Alpharma Inc., and previously served as Global Vice President of Compliance for Alpharma, where he was employed from 2004 to 2007. He has been a Director at Elite Pharmaceuticals, Inc since August 1, 2013. Mr. Hakim has also served as Executive Director of Corporate Compliance and Technical Projects for Watson Pharmaceuticals and Executive Director, Site Head of Quality and Compliance at TheraTech, Inc. Watson Pharmaceuticals acquired TheraTech in 1999. Mr. Hakim holds both a JD and BS in Law from Saratoga University in San Jose, California, a Masters degree (LLM) in Law from St. Thomas University in Miami, Florida and Bachelors and Masters degrees in Chemistry from California State University at Sacramento.
He's not a PRACTICING lawyer. He has a law degree and that is what matters on this subject.
Since you need full disclosure, call during the CC and ask NH your question. Easy.
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-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swingfor-the-fences
http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-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"
'newguy11'--Please post clickable link. Sounds great but we need a real link. Thanks
Likewise!
What a crock of BS! Most longs are long because they know that Great Thing$ are coming, and soon! Many have already made $$$$$$ and fully expect to make many times more $$$$$$$$$! Count me as one of the above-described.
Fortunately, NH's interests are aligned with Longs' interests,
so whatever he does will be--in his opinion--the best thing to do for himself and for all of us Longs! That's just fine with me.
All shares were purchased at the going price of the time purchased. NH's purchased on the open market. i forget how many millions of them.
And i also want to make sure that New Investors are clear that NH's interests are 100% aligned with the interests of Longs! He owns a very large percentage of the total shares. Somewhere around 23% i think.
Fortunately, NH's interests are aligned with Longs' interests,
so whatever he does will be--in his opinion--the best thing to do for himself and for all of us Longs! That's just fine with me.
FDA lifts hold on experimental Ebola drug
http://finance.yahoo.com/news/fda-lifts-hold-experimental-ebola-drug-212704896.html
What does this imply for ELTP? Plenty! like, for example: Restrictions eased and Fast-Track given to drugs for high-priority needs. Such as those that ELTP's ADTs address.
You're still here so you must have at least a small amount of hope for an improvement, right?
Why did it go to .09 earlier this year? If it did it once, it should be able to do it again. Or just go to .05--that's really all i ask…then i'm outa here. (Got more conservative since the other day when i said .06). Just .05. Surely they can manage that???????????
It doesn't have much further to fall. We took the sh-t so you don't have to. But will it ever go up again? That is the question...
"This is special"...what do you mean "special"? Special pos?
The PPS right now is the absolute worst it has been in years--possibly ever (i can't face going thru the entire yahoo historical price collection).
WHY??? What is the meaning of this?
Is the company going belly up or what???
As soon as pps hits 0.0666, i'm outa here! It should eventually get there seeing as it hit .09 earlier this year. In the distant past, it was much higher. Above .35. Wonder what happened…???
The sooner the better, imo. To outpace potential competitors. (even tho the competition isn't as good).
Nasdaq2020--"Holding for 4-5 ART/ADT launches"--what PPS are you expecting at that point? and what time frame?
I keep saying, everyone on this board should contact management: answer the phone, reply to our, emails, schedule a conference call, let us know wtf is going on!!!
Phone: 866 601-2639
Email: staff@efftec.com
Website: http://www.efftec.com
Dr. Shawn Clinton CEO
If you want enlightenment as to what is actually going on with the company, ask Couch. Meanwhile, checkout this amazing summary of events he recently posted:
10 Reasons Why ELTP as a penny stock just makes dollars and cents: NOW $$$$$$ & ¢¢¢¢¢¢¢
*****Side Note to Potential New Investors: Any way you slice it Elite is a low risk penny stock with the capability of being the illusive 10 bagger from today's current PPS by the end of 2015. And a note of comfort. Even if you buy shares today and Elite never does anything further with its abuse resistant technology (ART), Elite would still be a double bagger from here on its generic products alone. Thus the risk is extremely low and the return is at minimum a 10 bagger if Elite markets that whole line of ART products the COB Jerry Treppel mentioned back in 2012. Good luck and if you have questions ask the board. It is extremely knowledgable about this company and stock. My personal favorite #5: Elite's Intellectual Property Rights!
1) Low debt load, 2) Strong management team, 3) Expanding market share, 4) Growing revenues, 5) Game changing intellectual property rights, 6) Access to financial funding sources, 7) Management with skin in the game, 8) Highly undervalued stock, 9) Expanding Infrastructure, 10) Meeting short, mid and long term objectives.
1) Low Debt Load ~~ $18 million in assets - $23 million in liabilities and we know Novel is worth way more than $3.3 million on the books. I'd say if you include Novel's real value to Elite, Elite would come out at least even.
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=9782153-927-228722&type=sect&dcn=0001144204-14-008935
2) Strong management team ~~ nobody can say otherwise at this point. Adding Nasrat, Doug Plassche and Barbara Ellison to Elite's management team makes Elite much much stronger than it was a single year ago. It has moved from the bush leagues to the majors IMO. Not to mention all three were hired with the focus of getting Elite's ART to market. Then you add in Ashok Nigalye who is Elite's CSO and Epic's CEO and you get a top notch addition to Elite's management team. His work at Actavis alone stands out. From August 1993 to February 2008, Dr. Nigalaye served as Vice President of Scientific Affairs and Operations of Actavis Totowa LLC, a manufacturer of generic pharmaceuticals, where he was responsible for directing and organizing company activities relating to pharmaceutical drug manufacturing, regulatory affairs and research and development.
http://www.elitepharma.com/investor_relations.asp?goto=361
http://www.elitepharma.com/investor_relations.asp?goto=363
http://www.elitepharma.com/investor_relations.asp?goto=381
3) Expanding Market Share ~~ As Nasrat has discussed publicly Elite has gained access to new API sources for several of their generic products and their Phentermine prices are the lowest on the market. As Carter Ward has explained during several CC's most of Elite's generic products are less than 2 years on the market and they continue to gain market share quarter after quarter. Additionally, the 12 Andas purchased from Mikah will only continue to give Elite access to a broader and stronger commercial base in the generic pharmaceutical market. This can be proven by the numbers increase tied to their revenues.
http://seekingalpha.com/article/2029611-elite-pharmaceuticals-ceo-discusses-f3q2014-results-earnings-call-transcript?uprof=45
4) Growing Revenues ~~ and will only continue with Elites 12 additional Andas
SIX quarters averaging quarterly revenue gains of 93%.
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%
http://finance.yahoo.com/q/sec;_ylt=A0LEV1p7HUtTGnUA.ARXNyoA;_ylu=X3oDMTEzcXRzaTdxBHNlYwNzcgRwb3MDNQRjb2xvA2JmMQR2dGlkA1ZJUDM2NV8x?s=ELTP+SEC+Filings
5) Game Changing Intellectual Property (IP): (And why I am personally here!)
http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-killer
Elite Pharmaceuticals Expands Abuse Deterrent Technology Patent Portfolio Internationally
http://www.elitepharma.com/investor_relations.asp?goto=379
Quote:
“We are excited to have received this patent in Canada as we continue to broaden our patent protection not only in the United States but also internationally,” stated Nasrat Hakim, President and CEO of Elite. “We will continue to work toward the further expansion of our patent estate in the U.S., Canada and Europe. This patent supports Elite’s initiatives as we develop and file our new abuse deterrent products.”
6) Access to Financial Funding sources to support their signature product line: ART
Acquired $10 million from LPC and would be able to generate another $39.5 million from selling Preferred I shares to a big pharma partner and/or financing partner if the Proxy Vote passes. And TODAY we find out Elite garners another $40 million in funds from LPC at no upper limits to pay for shares!!
http://www.streetinsider.com/Press+Releases/Elite+Pharmaceuticals,+Inc.+Secures+Funding+Commitment+of+Up+to+$40+Million+From+Lincoln+Park+Capital+Fund,+LLC/9376047.html
http://www.elitepharma.com/investor_relations.asp?goto=356
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001144204%2D14%2D006951%2Etxt&FilePath=%5C2014%5C02%5C07%5C&CoName=ELITE+PHARMACEUTICALS+INC+%2FNV%2F&FormType=8%2DK&RcvdDate=2%2F7%2F2014&pdf=
7) Management with a lot of their own Skin in the Game!
Both Nasrat Hakim and Jerry Treppel own a large number of common shares and have loaned the company $1 million dollars unsecured. Nasrat owns around 154 million shares after the Preferred I shares and around 14 million besides the Preferred shares. I think JT owns somewhere around 8-10 million shares.
http://www.elitepharma.com/investor_relations.asp?goto=351
http://www.elitepharma.com/investor_relations.asp?goto=368
8) Highly undervalued stock particularly with their IP Rights.
One can see this by Elite adding in their poison pill policy/stockholder rights plan and having a prominent consulting firm give a valuation estimation with a conservative, most likely and best case valuation. That’s $0.40, $2.10 and $2.75. So even with Elite's worst case conservative scenario, I would argue Elite is still highly undervalued. Elite launches just one ART product even with the increase in AS and Elite would still be looking at around a $3 PPS if not more on the expectation of future ART products.
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001144204%2D13%2D062436%2Etxt&FilePath=%5C2013%5C11%5C15%5C&CoName=ELITE+PHARMACEUTICALS+INC+%2FNV%2F&FormType=8%2DA12G&RcvdDate=11%2F15%2F2013&pdf=
9) Expanded Infrastructure:
A few years back Elite expanded its GMP and DEA registered facility for research, development, and manufacturing from 15 thousand to 30 thousand square feet and added machinery for packaging as well. It further bought equipment recently so Elite could manufacture Isradipine itself as opposed to having Epic perform this work. Thus, Elite gets a cut of the manufacturing revenues. Additionally, Elite has hired several new key employees and introduced new products as mentioned. From 0 products on the market in 2011 to 8 currently to 16 employees to now 33. However, the real piece of good news here is that Elite has been using its expanded equipment line for the number of batches manufactured and stability tests run in regard to its ART products and is on schedule to submit its first NDA to the FDA by the end of the year.
http://www.elitepharma.com/investor_relations.asp?goto=354
10) Meeting its short, mid and long term objectives:
One would have to go back to 2009 when Elite delisted from the Amex and JT secured a strategic alliance with Epic for $3.75 million dollars and thus staving off bankruptcy to understand how far Elite has come in such a short time. At that time, Elite used this money to buy several Andas such as hydromorphone, Naltrexone and Phentermine that Elite currently markets. Additionally, as mentioned, Elite obtained key US and Canadian patents related to its abuse resistant technology, doubled the size of its manufacturing space and obtained funding from LPC to move forward with its pivotal BE ART studies after a 7 year hiatus. Further, Elite hired Nasrat Hakim as its CEO and re-initiated attending the Rodman & Renshaw financial conference in NYC after a 6 year hiatus. To me, this signaled to institutional investors that Elite is once again a viable stock and company and to place Elite on their radars. In essence, Elite has something worthwhile to show potential new investors. That it is moving towards becoming cash flow positive off both operations and soon R&D costs but most importantly it plans to launch its first ART product in 2015.
http://www.elitepharma.com/investor_relations.asp?goto=365
There is also this great update on studies:
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good excellent result. Even though this was second BE study but first pivotal BE study but will be first NDA to be filed with FDA in 2014. Life Tree Abuse studies have been initiated have most likely finished with dosing. Results to follow in a month? 45 days?.
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT.pilot BE Study done and good excellent result. Will be filed NDA with FDA in 2014 Nasrat has said he will file one NDA this year so early filing for 201 should not be expected, but it is not impossible or early 2015. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin. Pivotal BE studies began July 15. Results by end of September.
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT. BE study results due any day now.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.BE studies to be initiated some time in 2014.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.Perhaps an update at the next CC, in two weeks.
Gives me one more day to buy more!
The question is: what will create a 10million volume day???
It's an official announcement, whatever you want to call it.
PR July 31st:
Efftec International, Inc. Announces Strategic Partnership With Online Retailer
TULSA, OK--(Marketwired - Jul 31, 2014) - Efftec International, Inc. (OTC: EFFI), a holding company focused on direct acquisition and development in growth industries, is pleased to announce that it recently has executed a formal Strategic Partnership Agreement with Nemestrinus Ltd. ("Nemestrinus"), a United Kingdom company.
Nemestrinus is headquarted in the United Kingdom, and owns and operates a number of online marketplaces. The marketplace of principal interest to Efftec is Nemestrinus's main site, which can be visited at http://www.bitcoinseedstore.com/. The synergies between Efftec's PotSnob iOS(TM) and the services and markets provided by Nemestrinus are both direct and relevant, and as such, the Companies are very pleased to be working together for mutual benefit.
As a provider of a large number of high-quality, high-potency seed strains to its customer base, Nemestrinus is consistently updating its selection to include new hybrid and 'custom' seed varieties, as well as a variety of other cannabis-related products available through its marketplace. Currently, the Companies are advancing discussions on a number of collaborative efforts which we envision will be highly advantageous to both, and we expect material agreements be agreed upon in the very near future.
Efftec International, Inc. (OTC: EFFI) is a holding company whose focus is the acquisition and development of proprietary technologies. The Company is actively expanding its footprint in the technology marketplace through acquisitions of valuable IP and existing companies with proven business models.
You can't imagine that insiders wouldn't own shares of their own company, yet it is not posted anywhere so far as i know. Why not???
Info about Insider holdings is usually publicly and easily and transparently available. But not with EFFI. The question is: Why not??????? What are they hiding?
Insider holdings and insider buying are extremely important clues to the health of the company and the confidence (or lack thereof) that the CEO and other insiders have in the company.
It is crucial info that shareholders should have access to! We need to know if they have their own skin in the game! Do they share the same risks that we have taken?
Well it sure hasn't been for many months at the least. But if enough people call and demand it, maybe there would be a change...
Company needs to hear from all on this board demanding to know when there will be a conference call, when will someone at the company answer the phone or reply to an email, and how many shares are owned by CEO and other Insiders???
If everyone reading this would contact management with these questions, we might get some answers.
Instead of attacking me for asking these reasonable questions, ask them to answer these reasonable questions! (I have asked politely and have not heard back from them).
Toll Free:1-866-601-2639
The point of a message board is to share info with the other members.
It's been up a half penny or a whole penny many times, but it's fallen right back down again.
And probably will this time too.