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Six Sigma is a set of tools and techniques/strategies for process improvement.
See wikipedia:
http://en.wikipedia.org/wiki/Six_Sigma
Doug's LinkedIn profile: A nuclear engineer to boot?
Pharmaceutical Executive with extensive FDA experience and a proven track record of authentic leadership. A Certified Six Sigma Black Belt, who delivers cost effective improvements by quickly assessing and grasping the critical organizational and technical issues, and efficiently implementing needed systems, procedures and operational changes. Proven ability to assimilate new technology quickly and lead effectively in a variety of organizations, environments and cultures. Proven skill, in assessing talent and building high performance teams through; careful selection, individual development and stretch goal setting. Results driven in all critical areas including: quality, compliance, process, operations, finance and personnel development. Proficient in extensive dosage forms, equipment and technologies including; aseptic processes, sterile injectables, biotechnology, solid oral dose, liquid, semi-solid, and inhalation.
Experience
Managing Director NJ SOD
Actavis
January 2010 – May 2013 (3 years 5 months)
Multiple Site Head Responsible for all Plant operations, ~ 4.5 Billion annual ext units, ~ 35 Million annual packed units, ~ $72 Million annual budget, ~ 450 heads.
ActavisDir Manufacturing
Actavis
May 2009 – January 2010 (9 months)
Re-Start of Operations post Consent Decree
Par PharmaceuticalSr Dir MFG
Par Pharmaceutical
March 2007 – May 2009 (2 years 3 months)
Responsible for all operations ~2 Billion ext units, ~20 Million packed units, ~$35 Million annual budget. ~ 200 Heads
Schering PloughDir Prod Operations
Schering Plough
January 2000 – February 2007 (7 years 2 months)
Director, Production Operations (Aerosol/Liquid Ointment Cream/Dry Powder Inhalers) (2000-2007)
Schering PloughDirector Engineering International Technical Operations
Schering Plough
1998 – 2000 (2 years)
Responsible for capital improvement projects for manufacturing plants located in Latin America and Far East.
Mgr MVI(Mallinckrodt Vet) Integration
Schering Plough
1997 – 1998 (1 year)Europe, Latin America, Far East
Integrate Mallinckrodt operations into SP
Mgr Start Up
Schering Plough
1996 – 1997 (1 year)Singapore
Lead the commissioning and qualification activities for a $250 Million Green Field Synthesis and Steroid API facility
Education
Cranfield University - Cranfield School of Management
Certificate, Business
2010 – 2011
ASQ
Six Sigma Black Belt
2006 – 2006
Navy Nuclear Engineering
Masters (equivalent), Nuclear Engineering
1985 – 1987
Univ of Rochester
1981 – 1985
Might as well give the link and credit:
http://seekingalpha.com/article/1463281-actavis-abuse-deterrent-opioid-connections
There's much more to the listing requirements than just $4/share.
http://www.investopedia.com/ask/answers/121.asp
They will pick off the two ANDA's that are in the smaller markets w/ minimal competition.
Do some homework and you will see that just two of those ANDA's could easily bring 5 to 8 million in sales.
The rest they could file CBE30's for and decide to add to pipeline or just monetize.
Some of them will likely be resold for $2-3 million.
So for $7,000,000 to $8,000,000 they probably can generate $5,000,000 to $8,000,000 in annual sales.
Not so bad huh?
I suggested this a long while ago.
Naltrexone is far more valuable for use in testing batches for ART than it is as a revenue stream in and of itself.
poorme:
1) Who claimed Elite has the ONLY technology. Why would you say that?
2) Why would the article need to say Elite is the leader in ART technology? Does every article posted on this board need to say that for you to consider it worthy?
3)It's a highly relevant article about abuse resistant technology. Maybe you missed it but Elite is developing abuse resistant opioid drugs. Reading articles like this can increase your subject knowledge in the field that you (perhaps) have your hard earned money invested in.
We are here to share information to make us better informed investors are we not?
Finally did you ever consider the fact that the first words in the subject are: "Extended-Release Hydromorphone" ?
Did you know Elite makes Hydromorphone?
Did you know Elite owns extended release technology and patents?
Do you think it's reasonable to speculate that Elite could have an opportunity here?
Regards,
Hike
http://www.painmedicinenews.com/ViewArticle.aspx?d=Web%2bExclusives&d_id=244&i=July+2013&i_id=979&a_id=23638&tab=MostRead
Extended-Release Hydromorphone May Mitigate Drug Abuse
NEW ORLEANS—Rates of abuse, misuse and diversion of the opioid hydromorphone have decreased since the introduction of an extended-release formulation of the drug in March 2010, according to a poster presentation at the 2013 annual meeting of the American Pain Society. Conversely, rates of hydromorphone diversion and nonmedical use have not increased during that time period.
The Exalgo (Mallinckrodt) formulation of hydromorphone allows gradual release of the drug into the patient’s circulation, and includes a tamper-resistant technology (OROS, Alza) to reduce the likelihood of abuse. The effectiveness of these properties in lowering rates of abuse, misuse and diversion has not been studied previously, the researchers said.
The analysis (poster 419) was based on data from five programs collected by the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System: opioid treatment programs, the Survey of Key Informant’s Patients (SKIP), poison centers, a college survey program and a drug diversion program.
“The different data sets were used because there are various reasons and motives for abuse, so in order to obtain an accurate and valid assessment of illegal drug use trends, several sources need to be assessed in multiple locations in the country,” said senior author Lynn R. Webster, MD, director of CRI Lifetree Research, Salt Lake City, and president of the American Academy of Pain Medicine. “Some patterns of abuse can be more prevalent in certain areas of the country, while less or absent in other areas. The complementary sources improve the validity and accuracy of the data.”
Assessments of changes in rates of abuse, misuse and diversion were made by comparing the slopes of graphs before and after Exalgo’s introduction. The cutoff date of April 1, 2010, was set for pre- and post-Exalgo periods. Two rates were calculated: one based on population per 100,000 and the other on 1,000 unique recipients of dispensed drug (URDD).
The mean rate of abuse in the RADARS program prior to the introduction of Exalgo increased by 11.9% for the population group and 7.6% for the URDD group (P<0.001 for both). A nonsignificant decrease to 1.4% for the population group and 4.4% for the URDD group followed Exalgo’s introduction. The positive slopes of the rates of change prior to introduction were significantly different from the negative slopes seen after the release of Exalgo (P<0.01). These results were mirrored in the other four programs.
Dr. Webster and his co-authors indicated in their poster that it is unclear if the trends reflected in this study indicate overall patterns of nonmedical prescription opioid use. Instead, they posit the trends may show that the availability of Exalgo has mitigated increases in hydromorphone abuse and misuse.
“Ongoing monitoring will be important to see if there is a change in abuse of Exalgo over time or as more of it is prescribed. Of course, the abuse of any drug, including Exalgo, is influenced by the availability of alternative drugs that can be easily abused,” Dr. Webster explained. “So, as new abuse-deterrent formulations replace older non-deterrent formulations, there could be a shift in choice of drugs abused. Monitoring the impact of new drugs on patterns of abuse will be important.”
More Evidence Needed
“These results are very encouraging, although we know that abusers can be inventive in finding ways to misuse a substance and individuals will always be able to take multiple doses of an opioid to achieve euphoria,” said Robert N. Jamison, PhD, professor of anesthesia and psychiatry at Brigham and Women’s Hospital, Harvard Medical School and Pain Management Center, Boston.
Dr. Jamison said continued studies are needed to identify people at greater risk for opioid misuse.
“Also, more evidence is needed that abuse-deterrent and tamper-resistant formulations should be favored over traditional opioids in treating pain,” he said. “Overall, these results offer some hope in the future reduction of abuse of prescription opioids.”
http://biotuesdays.com/2013/08/06/elite-eyes-home-run-in-abuse-resistant-technology/
Elite eyes home run in abuse-resistant technology
Also note that they added another Undisclosed Generic:
Undisclosed Generic Undisclosed Undisclosed ANDA Pending FDA Approval Owned by Elite
Lots to digest here.
Not to rain on the parade but although this is very good news ...nothing in life is free.
New very well qualified CEO and President? Good, very good. He's also a fairly young man at 52.
However he gets a $350,000 salary payable in shares. So there will be some dilution. 5 million shares/year at current price. Plus he is eligible for a 100% bonus if he hits certain milestones, also payable in shares. So that's potentially 10,000,000 shares per year at the current price. Again, hopefully hitting those milestones means a higher stock price regardless of the dilution.
Several New Products added to pipeline? Good
$10,000,000 for the new products payable in a note due in three years? We'll have to see just how valuable these ANDA's are before determining if that was a good price. The note is convertible to shares at .07/share after one year. So potentially 143,000,000 more shares...more potential dilution. However one would assume that the conversion would only take place if the shares went significantly over .07/share.
Hopefully we can get the spreadsheet updated with projected launch dates and potential annual sales. Any help you guys can give would be most appreciated.
It seems an absolute certainty that this deal will allow Elite to be PROFITABLE and self fund their ART studies and maybe even work off the NJEDA debt.
Looking forward to many more announcements.
My opinion was clearly elucidated.
all prs are forward looking statements?
Uh no.
A pr may contain forward looking statements. They also typically contain many facts.
This is a fact: (several facts actually)
Consolidated revenues were $3.4 million for the fiscal year, an increase of $1.0 million or approximately 40% over consolidated revenues for the prior year. Revenues for the quarter ended March 31, 2013, were exceptionally strong, totaling $1.5 million, the highest quarterly revenue level in corporate history, 131% above quarterly revenues for the comparable period of the prior year.
This is a forward looking statement:
Most importantly, I can now tell you that we expect our first commercially scaled-up, abuse-resistant opioid product to enter human pilot studies later this year.
Just read the filings? If Elite released a PR tomorrow stating they had a partner for the ART drugs you wouldn't believe it?
And what is your definition of speculation and why is it bad?
Thanks I feel better now.
You think Nalrexone launch is delayed because its needed for ART trials first?
Hit the inbox at 8:02AM this morning....
from Paragon:
“I see ARTH as one of the best finds of my career, a potential blockbuster for shareholders as well as being a top-tier medical breakthrough that could one day save your life.” – Analyst Ian Cooper
Members,
Respected analyst Ian Cooper has spent the better part of the last decade mastering the art of trading options for triple-digit gains, avoiding the "herd mentality" of Wall Street. He has shown thousands of investors exactly how to exploit carefully targeted market sectors for lightning-fast short-term gains. Just this week, Ian Cooper has issued his new “Speed Retirement System” report highlighting the New Technologies Revolution. In this report, he focuses on Arch Therapeutics (ARTH) as his stock to follow this year. Below is an excerpt from his Summer 2013 Special Report:
Ian Cooper’s Speed Retirement System, Special Report, Summer 2013:
“This may be the most important medical discovery in decades and it could earn you a fortune!
To the Informed Investor:
Medical breakthroughs often become huge moneymakers for ground-floor shareholders, but nothing I've seen in recent memory is as far-reaching as this. The stock I recommend for immediate consideration is Arch Therapeutics (ARTH). Within months, Arch Therapeutics could become the most talked about medical company on the planet and its stock, ARTH, could be selling three- to five-times what you can get in for today. The reason is simple:
Arch Therapeutics is preparing to release a ground-breaking new medical product that could benefit the entire global population.
Yes, I mean everyone, over seven billion people in a market exceeding 32 billion dollars!
This revolutionary medical product, called AC5™, is reported to do one thing better than anything else on the market today.... When applied to an incision or wound, AC5™ stops the bleeding and seals the wound almost instantly.
When you look at the global reach and numbers for AC5™, it could be the fastest growing medical product to be introduced in decades!
Bleeding is a fact of life, yet despite all the medical advances made in our lifetimes, bleeding control has stayed largely unchanged for over 100 years. Recently however, researchers at the Massachusetts Institute of Technology (MIT) developed a breakthrough for bleeding control. One noted surgeon calls AC5™ the “Holy Grail”. Another calls it a“gamechanger” that he would use in “80 percent of my cases.”
Clinical tests conclusively show that AC5™ stops blood flow in seconds rather than minutes... up to 30-times faster in many applications!
From an investor’s point-of-view, ARTH is one of the best growth opportunities I’ve seen in years; I urge you to act on this immediately!
This is a pivotal time for investors to move on ARTH. From here on in...
All progress to market amplifies ARTH growth potential.
Every announcement carries significant potential for share price gains.
By the end of the year, ARTH could be a 3.00 to 5.00 dollar stock and climbing.
Longer term, ARTH could be a 20 dollar stock or better either through global market gains or acquisition by a major such as Johnson and Johnson, maker of Band-Aid® products.
The lengthy research and development phase is complete; Arch Therapeutics now enters the final phases that lead to market release. Closing in fast, this opportunity is one to act on immediately.
In my view, this is a slam-dunk for biotech investing.
An urgent investment opportunity
This is such a revolutionary product, a real game-changer, that news of AC5™ and Arch Therapeutics could spread like wildfire through medical and investment communities. If you are thinking of getting ARTH into your portfolio at today’s bargain price, then make your move immediately. These may be the final moments of ARTH as a ground-floor investment.
As soon as investors get wind of this, I anticipate a flood of buying that could get started at any time now. Currently trading around one dollar, the short-term potential for ARTH to hit the 3.00 to 5.00 dollar mark can be driven by a cascade of post-R&D developments.
ARTH has buy out potential written all over it!
My guess is that someone big is going to take ARTH out, paying an enormous premium to own this exciting new technology. Top of my acquisition prospect list is Johnson & Johnson (JNJ). AC5™ has the potential to demolish JNJ sales in its wound-care products. This includes its heritage brand, Band-Aid, which along with all its products in consumer wound care category generated $1 billion in sales for JNJ last year.
My conclusion is that AC5™, once released to the medical world, can rapidly reduce the risk and expense of bleeding management and greatly improve patient outcomes. As an investment, I rarely see an opportunity this good!”
Read Ian Cooper’s Complete Analysis of ARTH – Select Here to read the full Report
Members, you heard it here first! Respected analyst Ian Cooper has just released his Summer 2013 “Speed Retirement System” Report highlighting our featured company Arch Therapeutics (ARTH). We encourage all of you to read his full report now by selecting the link above. If you have not done so already, now is the time to research ARTH before its share price potentially skyrockets to Ian Cooper’s short-term price target of 3.00 dollars. Do not delay, research ARTH now! www.archtherapeutics.com
Sincerely,
The Paragon Team
Poorme
The statement:
"value would be represented by an increase in the stock value"
Is referring to the increase in the value of the stock In Novel that Elite owns. That stock has certainly increased in value.
The projections on the launches are purely guesses and based on history I would say my guesses have been decent but on the optimistic side. It's hard to know what the next launch will be and just how much work needs to go into it.
What do they know...
Did you apply?
Not heavy at all ...
Kinda of like complaining the bag of money someone just gave you was too heavy.
Sorry you are frustrated. Looks like another day for LPC funding so how bad can it be?
Hey easy on the new guy!
Their website made by same guys that made website for ECAU.
Coincidence? I think not.
Do hotcakes really sell that well? Just wondering.
Paid promo and pumps aside....is this a "real" company with a "real" product or it all ether?
U.S. securities markets will close at noon CT on Wednesday, July 3 and remain closed Thursday, July 4 for Independence Day. Any orders placed after the early market close Wednesday, July 3 will be submitted for Friday’s regular trading session.
This may be news to you but trials cost money. They finally have the money now.
Elite and Mikah have 3 or 4 Phd's and an MBA or two. Not too shabby.
Apple started out of a garage...
And you missed my point as well. Frankly I am shocked and dismayed.
If I looked at every stock I wanted to invest in and said, "Hey the price it is today must perfectly reflect that stocks value!" I would never buy a stock.
This may explain why some folks spend so much debating here. They don't actually buy stock because they assume the price already perfectly reflects the stock's value.
Actually yahoo reports the market cap at $29 million. Not the same thing.
Edit; Hundreds of million dollars....
No what he is pointed out is that for the 526,000,000 shares to be "outstanding" as opposed to "fully diluted" that means that we would have received the full $10,000,000 in LPC funding which would easily fully fund the studies for ELTP's ART/ADT which in turn would indicate that ELTP was on it's way to hundreds of dollars in revenue. In other words, that would be a good thing.
"Fully Diluted Shares" is a "theoretical" number of outstanding shares if all possible sources of conversion, such as convertible bonds and stock options, were exercised.
So, ELTP has not "fully diluted". They may never do so. They might sell their Novel interest and not need to dilute further w/ preferred exercises or LPC purchases.
So, it's an "illusion" to think that the diluted share count is the "outstanding share count".
This is all publicly available information. If you don't know what fully diluted shares or outstanding shares or authorized shares or "float" mean DO NOT invest in penny stocks. Or any stocks for that matter.
What is there to discuss? It is what it was, and always has been.
Nas...good start
Also:
Rexista™ (Oxycodone)
http://www.intellipharmaceutics.com/product-detail.cfm?productID=118886
Abusolve (not a drug but a delivery system)
http://www.encapdrugdelivery.com/news-and-events/articles/encaps-abusolve-technology-successfully-used-to-develop-new-abuse-resistant-medication
A slew of others mentioned here in this year old article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411218/
Would be great to estimate and chart where they are in development.
Looks like as many as 15 products. I imagine many won't be deemed effective or just won't get to market. So "maybe" it's safe to say there could be maybe 8 products that compete for the $3 billion market. If Elite's tech works and gets to market $100,000,000 in sales is not unrealistic.
Ummm, what?
Wouldn't hurt if someone compiled a list of ART/ADT products on the market and in development. There certainly are a few. Or perhaps that is already done?