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I have ben wrong on many of my price targets/dates, but what I have not been wrong about is when i have said Elite will make huge progress. They have. Predicting prices at certain dates is a guess, and only a guess. Many have missed both ways.
But what I would like to hear is one argument why Elites tech will fail. What about the chemical/physical characteristics of Elites ART is suspect to you? What test results have been questionable?
Elite does not put out fluff pr's.
THey seem to only pr what they are required to when they file an 8k.
Please list the pr's that you think are fluff and why.
ELTP 2015, going to be one heck of a great ride.
What, link please??
Who said they will not approve it???
The company is prepared and could file an NDA at any moment.
But the smart thing to do is to bring the FDA into the filing process so there are no surprises on either end.
Clear sailing for Elites ART.
None of the folks who think Elite will fail have the tried to answer the below question, what your thoughts on the science?
So in what way do you think the chemistry or physical properties/functions of Elites art will fail?Where is the flaw?
So in what way do you think the chemistry or physical properties/functions of Elites art will fail?Where is the flaw?
No one has shown data or made educated guesses as to why Elites ART will fail. No one!!
So unless you have some thoughts on that, 3-5 bucks, yup thats why I am here.
You may very well be correct.
I think a buyout is very likely around the time of first art launch, (AUG) at which time ELTP will no longer trade.
" if everything goes as planned- by the end of 2015 I'd say $1-3."
It ran to a dollar less than a year ago, and if look at what has been accomplished since the run,imo it will blow past a dollar before March.
GLTA Longs
It is very hard to guess how high this will go once the plug and play tech gets validated and recognize by the street.
ELTP will fly, and a good portion of it will happen overnight. IMO
Welcome,
imo great price.
So in what way do you think the chemistry or physical properties/functions of Elites art will fail?Where is the flaw?
This is where the debate should be, yet no one has shown data or made educated guesses to why Elites ART will fail. No one!!
Just a gut feeling, and Jan effect.
Today will be the start of many green days.
GLTA Longs
Their progress has been nothing short of incredible since NH has come on board.
Can't wait for one or two more pr's to help the street connect the dots, then folks will be kicking themselves for not buying more, a lot more.
GLTU and all longs
Great post, 5 star!!!
Hard to argue with facts!!
Very funny , Tang
No wait they are both companies.
GLTU
Wow, not even close.
Please list the similarities besides waiting on the FDA. Waiting waiting,,,,,,,,,,,,,,,,,,
"waiting on the FDA" Which Elite does not have to do but has listen to camargo who has advised them to wait to file until the FDA feels comfortable with the info provided.
Still going to launch in Aug, and nothing anyone can do about it, except get rich.
How is he going to do that with out selling. He did not sell at .90 or above, what do you think his target is?
The below little table shows up when I go to ihub, shows me how I did compared to Etrade Fin alternatives. I smile every time I look,imo next year will be much better.
ELTP vs ETF alternatives
ETFs Today 3mths 1Yr YTD
ELTP -1.97% -27.58% 87.08% 87.08%
IJR 0.00% 8.70% 5.46% 6.41%
EES 0.00% 7.56% 2.10% 3.14%
SCHA0.00% 6.83% 6.16% 6.90%
VIOO 0.00% 8.05% 4.20% 6.45%
VB 0.00% 5.05% 7.35% 8.04%
DWAS0.00% 8.94% -1.65% 0.94%
SAA 0.00% 18.02% 8.99% 11.85%
Now wait, i thought it was dependent on the filing for an NDA, now its all about the 5 year chart.So why do you think NH bought more shares and has not sold. Does he think the 5 year will turn around?
How is he going to make money, taking shares for salary, loaning the company a million, then taking shares. I will follow the money of the most knowledgeable insider.
Me i am happy with my YTD returns on ELTP, also up 6 of last 7 days.
I thought only TA matters?
FDA already said expedited review.
A person can buy now before they get the all clear from the FDA or after, efficacy trials won't stop a drug launch in Aug and are a slam dunk.
GLTA Longs
Yes ELTP fundamentally very very very solid and moving off of tax loss selling lows.
Pretty light volume so those buying may have a hard time accumulating a LG position, although once JAN comes and volume returns I expect the price to be 30% higher at a min.
Last years run was about a 10x on a company that is not nearly as strong as it is today.
GLTU
ELTP
The below is just some of the DD on ELTP.
This company imo will be over a dollar in the next 6 months, and will have sharp gains in Jan.
Do your own DD, but the info below is pretty impressive.
CEO just bought 700k shares on the open market in IRA, over 200 k dollars worth.
NO ONE CAN STOP ELITE
--Multi-Billion dollar pipeline of over 40 drugs which includes 17 NDA Abuse Deterrent opiods
--no more going concern
--strongest balance sheet in Elite's history
--first working capital surplus in 5 years
--9 QUARTERS AVERAGING REVENUE GROWTH PER QUARTER OF 73%.
--600% increase in R&D expenses
--$40 MILLION in funds secured from LPC(Lincoln Park Capital) to develop ADT/ART products
--$5 MILLION recieved from sale of Elite's past ownership in Novel Laboratories 06/10/2014
--Generic Business Cash Flow Positive "minus" R&D costs for last two quarters, approaching 2+ million in revenues per quarter
--Human Abuse Liability(HAL) study POSITIVE for ELI-200 an undisclosed Abuse Deterrent Opiod for pain, required to get valuable FDA ADT labeling !
--The Company’s primary focus has become the accelerated development of their complete line of Abuse Resistant opiods
--completed SUCCESSFUL pivotal bioequivalence studies on both ELI-201(twice day oxy ADT) and ELI-200(undisclosed twice a day)
--Abuse Liability studies for ELI-200 POSITIVE, This will allow for very RARE Abuse Resistant Labeling, other 16 ADT's to follow
--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, working on 7 ART opiods* concurrently in 2014, if fast track status granted at least one ART/ADT will be filed with FDA in Dec 2014
--Nearly Doubled the FDA-DEA-cGMP registered manufacturing labs to a total of 50 thousand sq/ft for research, development and manufacturing from concept to commercialization
--$500,000 invested in faclity expansion in 2014, new encapsulator, tablet press and high shear grandulator
--room for 3-4 in house ADT opiods
--NEW packaging line operational
--the longer we go without partnering or buyout the higher the value of the company
--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
--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
--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
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for multiple 12 hr ART generic and NDA opiods where Bio-equivalency studies alone are enough
trial #1 mega pilot 4 way cross over on 64 subjects SUCCESSFUL on 12 hr Oxy/Nal ELI-201 completed in 2013
trial #2 and 3 pivotal BE studies SUCCESSFUL for both ELI-201 (12hr oxy) and ELI-200 (12hr undisclosed) ADT
trial #4 and #5 Started 05-19 for ELI-202:the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-202, an undisclosed opioid abuse deterrent product, utilizing Elite's proprietary pharmacological abuse deterrent technology. Two bioequivalence studies will be run together for ELI-202.
2014 Lifetree 3 tier abuse deterrent studies to obtain * FDA ADT LABELING *
a) snorting trial completed POSITIVE
b) oral abuse
c) IV abuse
Human Abuse Liability study completed to test abuse potential of crushed ELI-200 taken intranasally -POSITIVE
ELI-200 believed to be morphine/naltrexone(a better Embeda) is also on schedule for a Dec 2014 FDA filing
trial #5 June/July 2014 ONCE/DAY 24 hr ELI-216 ** $$ will eventually be the ONLY 24 hr oxy in the USA $$ **
this one product may need a Phase III trial, FDA to decide after BE's
--pediatric study
--ELI-154 CR (once a day Oxy) in scale up for Large European Market
--CEO owns 23% of co. and has challenged team to get the First 12 hr ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7 Billion dollar market*******, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--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
--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
--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
Ya it ran .97 without the solid fundamentals that it has today.
So much DD on this company, ceo just spent 200k dollars more to buy shares and has not sold one share.
IMO it will easily eclipse .97 with more drug launches and the filing of the expedited NDA for a billion dollar product.
GLTU
ELTP
ELTP is very cheap right now, those buying now are buying at a huge discount to the price were the CEO just purchased shares.He spent over 200k dollars to buy shares above .30 in family IRA.
He will be in the green in less than 2 weeks imo
Merry Christmas to all my Elite ihub friends/longs.
You might want to check your facts on the float, or look at the def of float.
Welcome back.
We file for an NDA and .50s will be here for a day or two,the new base will be near a dollar. imo.
The company is still very confident of a launch in the Aug time frame even if efficacy trials are required. The trials will take about three months and be a slam dunk. Once the market connects the dots........ Up we go.
Showed around 100k on the ask at .22, got hit for about 30k and bamo, the last 75k vanished.
Whom ever was sitting there did not really want to sell. lol
imo
There will not be another generation investing in Elite, the symbol ELTP will be gone before this child reaches 2 years old, and it won't be because they went BK. lol
GLTU and all Longs
Look at the body of work by the poster. lol
Enjoy every moment!!!!!
Congrats!!!!!!!!!!!
I agree, those are minimums imo, its an unknown how much the market will factor in future revs, as each new ART will come out a little faster, we will also have some irrational exuberance at some point.
So who knows, but it is going to be fun, the fundamentals just continue to build even as the price has decreased. I believe the price turns in the next 1 to 3 weeks and may very well have already began.
GLTU
He has not sold one share, and my guess is Elite makes many millions off the generics before he sells one share.
If he hurts Elite, he hurts himself, and he just bought shares on the open market.
Very solid points, Great sarcasm .
I am not responsible for the shares I bought that were higher priced than Fridays close. Its all NH fault, what was he thinking?????
But I also have to give him credit for the majority of my shares bought below a dime.
Thanks NH, My investment advisor. lol
When the street connects the dots, we won't move up by pennies, we will move by dimes.
GLTU
Strong post,
I think we are close to the street connecting the dots.
GLTU
Great post,
GLTU and all longs
Congrats,
I think those buying now will be very happy come Jan.
GLTA Longs
As far as a partner goes, i believe the words were used, a decision on a partner by eoy. Elite can hire their own sales and marketing team, just pay them and not partner for a % of rev's. If they go it alone, will they PR that?
It was and has been stated by eoy was the goal to file an NDA. The fact is they could file today, but are getting all the boxes checked to assure smooth and expedited approval. I think Aug launch is very likely.
"Only a week of delay can have a serious impact on the price" On this market if they are 10 minutes late, folks sell and scream scam. So I agree.
GLTU
You say it might not happen for a while, but CEO who just bought 200k dollars worth of stock is having the company work and prepare to launch in Aug. I will follow the dollars.
GLTA Longs
Really??
What if it launches Jan 8th.
Would make no difference to me, just waiting for ART launch and retirement.