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Or maybe this was one of the negatives?
They have done the impossible. I have been in this business for 34 years. Nobody, no company had ever been able to take an NDA from beginning to end in a year or 1.5 year to FDA for approval. The team has done the impossible. If this was Watson, Actavis, Pfizer or ALZA Pharmaceutical everybody will be patting each other on the back and singing their phrases and my staff worked tangible [ph] unrecognized because we’re demanding from them hard work day in and day out seven days a week. So I’d like to give a shout out to them because they are the ones who have made Elite what it is.
Was this one of the negatives?
Doug Plassche - EVP Operations
Thank you, Carter, good morning everyone. Q2 was busy for operations. We had extensive R&D batch manufacturing to support clinical trials as well as significant optimization work on what I’ll call the next generation of the key intermediate. The formulation looks excellent, stability results look good and we are ready to start factoring this next generation into the best of the portfolio of products as we proceed.
We purchased and are preparing to install a commercial scale fluid bed process with a capacity of approximately 1,000 kilos a batch, versus our current maximum of 200 kilos per batch. With this capacity we should be able to achieve our target for ELI-200 and possibly the second product as well, depending on the market penetration.
Please list with links the things in the CC that you feel were negative.
Yea me to.
The CC was nothing but positive, I think we will hear from the FDA in short order given the pressure they are under from congress.
Nice post.
I agree, everything full steam ahead.
FDA will not take long to get back with Elite imo.
They need the tech, heck look at embedda.
These are regular back and forth communications before NDA filing,
My guess, they heard back from the Oct meeting before the Nov meeting and thus Elite was ready to go ahead with the next step. Finale look happening by FDA, then file.
GLTA Lomgs
Got some .28's
Great CC Just a matter of time.
ELTP
Yes and imo will the go ahead to file for an NDA with their potential blockbuster drug in a billion dollar market. Could be one heck of CC. Also will announce the timing on release of 3-5 more generics.
GLTU
I am hope full we will hear we got the go ahead.
But unless Elites has the minutes back from the FDA on the meeting, NH may or may not have the confidence to speak on their (fDA"s) position.
But then why he wait until two days after the meeting for CC.
GLTA Longs
ELTP
IMO a break out to the previous year high is very attainable which is a solid 300%.
Wed's CC imo will be huge, and will reveal the reason why the CEO just spent over 200k of his own money to buy stock on the open market.
GLTU
I am glad that folks haven't heard about this gem yet.
Allowed me to increase the size of my position at levels below what the CEO just bought.
But not after Wednesday.
GLTA Longs
ELTP huge news expected in the CC!
DD below is mind blowing both quantity and quality.
"We remain on track to file our first new drug application for ELI-200 by December 2014.” CEO
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
--8 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
A person could sell thinking Elite will have to run further tests.
For longs all that does is put off early retirement by 6 months, not a big deal.
GLTA Longs
Your chart could vert well be spot on.
We are sitting on a powder keg, Wed will be very very interesting..
"Last month the CEO added another 700,000 shares off the OPEN MARKET to his collection. I followed his lead ...."
Me to, I just did not have an extra 1/4 of a million to pick up that many.
I would guess a 1 for 2 that would take us to the 4 dollar range, but won't happen until ART is on the Market.
Chart sure is looking good!
"FDA meeting TODAY on NDA submission!!!"
I have waited a long time, Jerry T was great in improving Elites bottom line and moving the company away from BK, while launching a bunch of generics.
But NH has moved Eiit's ART toward market at a breakneck pace.
IMO
Short term Downside .265
Short term upside 1.25
Short term - by eoy.
BTW last year at this rime I predicted .30 by eoy I was off by a month or so, now I would guess around previous year high as year end price.
I am extremely optimistic for many reasons and think the company is moving forward rapidly.
I think the share price will approach a buck upon NDA filing of first ART.
But I also think what we here from NH on wednesday maybe a little guarded , and we may not know for sure if we can file in Dec for another week or two.
Either way, I have waited a long time for Elite to receive outside press for its blockbuster tech, and I think we are within a few weeks of it now.
GLTA Longs
Agree, great post.
"To use a football analogy; Elite did not make it to the playoffs"
So which ART/ADT would dominate "To use a football analogy" Elites tech in a head to head match up and why? lol waiting, waiting........
THere is not one!!!
"Guess no one is loading boats"
I have and so has a friend that I got involved after NH spent 200K on ELTP..
We both did below a dime.
What do you think the price will be when the FDA give them the OK to file for an NDA?
How do you think the price will react when Elite gets the ok from the FDA to file an NDA?
"I thought we sat down with FDA in October?"
How funny ,maybe he did , or maybe heaven forbid, I know this is horrible and I just may sell my whole position, but he met 17 days later. lol
LOL the way Nasrat is heading with all these horrible expenses, and additions to the company, we may soon find ourselves holding a company that is trading on the NASD. What shame. lol
I am very happy with the progress, 2 DAYS !! Yes 2 DAYS until we sit down with the FDA.
Little ole Elite, with a huge tech in a even larger market.
GLTA Longs
If I were NH and knew the FDA had required another test before NDA filing, would I have bought shares a month before everyone else found out at the CC, or would i have waited and bought a couple of days after the CC and the market had reacted?
Of coarse we would wait and buy them cheaper.
I believe we are on track.
We shall see.
I am not looking for numbers in the Q, just want the below statement repeated.
NH from last Q
"and are well positioned to file the first of our abuse resistant opioid products by the end of this year. We have emerged as one of the leaders in the development of abuse deterrent opioids. "
I would not be surprised to see great news released after the bell. not the way most companies do it. But Elite is not a P and D and does not attempt to time news to sell shares.
NH has been buying for the long term, and I will sell when he does.
Elite has a history of not attempting to time anything. That may have changed some since NH came on board. I remember a few year back a CC on a afternoon before the CHristmas break. It drove me nuts, the CC was great but the audience, well they were with families, shopping, serving ect.
It was me, four investors and three reindeer on CC.
WHere is the link for the dilution, oh wait there is not one. lol
What ever he is doing I sure hope he keeps it up, from .068 to .30, can't wait to see what the rest of the year will bring.
Still waiting on what art method you think will out preform Elites and why you think the method is superior. Maybe you missed that question, every time i have asked it.lol
I did not catch that, they do not normally give 3 days to process the info, I think one full day is normal. Don't know if it means anything.
I wonder if that means numbers on Monday, but I thought they were due on Friday.
GLTA Longs
"inevitable plummet after the cc like always."
IMO this CC will be different than the last few. We have had many times that price has been up after a CC and many times down.
If one knew for sure, he would be rich and retired.
If we are ,and I believe we will be on track to file, the price will rise and never look back imo.
GLTA Longs
"FDA wants ALL OPIODS to have some form of abuse deterrence"
Plug and play tech my friend.
Once the first one is approved the rest will happen very quickly.
ELTP
"A very good inside track have they said why the P&D is not going so good?"
Don't pump and Dumps put out a lot of fluff pr's?
Please list which of Elite's PR's are fluff and why.
Elite puts out very few press releases, only when 8k is required.
Do p n d's normally hold 150% for months and months? Let me help. Nope.
"Then the 20 Billion Dollar Pain Market will turn to other sources."
Frustrating, statements like this are made without even an opinion about the tech and other ART techs.
I think Elite's tech is simple, yet brilliant.
"Then the 20 Billion Dollar Pain Market will turn to other sources."
Why? In what way do you think Elite's tech is flawed????????
Elite has the money to bring 4-5 ART products to market, they have expanded their facilities and leadership. WHat about the tech do you think won't be as effective as the other products and why?
"Then the 20 Billion Dollar Pain Market will turn to other sources."
Really, please tell which other ART method you prefer and why you believe it will out preform Elite's tech.
Waiting, Waiting............
"I will flip some when we get 2-3 ADT OPIODS launched."
I have always thought I would not sell until NH does, ( unless I need a few K for family stuff).
I really think no2kolaid is correct though, NH won't sell any shares until Elite is bought.
Ready for a break out!!!
GLTU
ELTP
"I will flip some when we get 2-3 ADT OPIODS launched."
I have always thought I would not sell until NH does, ( unless I need a few K for family stuff).
I really think no2kolaid is correct though, NH won't sell any shares until Elite is bought.
Ready for a break out!!!
GLTU
ELTP