HOLDING STRONG!
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Elite's Chart!
Bollinger Bands are super tight!!!!!!!!
Way oversold!!!!!!!!
Even the hint of an approval of sight transfer or ANDA or good news about SequestOX will set off a huge up run!
Elite way OVERSOLD!
from article on a technicals!
Traders may be trying to figure out whether it is a good time to enter or exit a position in Elite Pharmaceuticals Inc. (ELTP). The Average Directional Index or ADX is a technical analysis indicator used to describe if a market is trending or not trending. The ADX alone measures trend strength but not direction. Using the ADX with the Plus Directional Indicator (+DI) and Minus Directional Indicator (-DI) may help determine the direction of the trend as well as the overall momentum. Many traders will use the ADX alongside other indicators in order to help spot proper trading entry/exit points. Currently, the 14-day ADX for Elite Pharmaceuticals Inc. (ELTP) is 7.55. Generally speaking, an ADX value from 0-25 would indicate an absent or weak trend. A value of 25-50 would indicate a strong trend. A value of 50-75 would signal a very strong trend, and a value of 75-100 would indicate an extremely strong trend.
Taking a look from a different technical standpoint, Elite Pharmaceuticals Inc. (ELTP) presently has a 14-day Commodity Channel Index (CCI) of -75.04. Typically, the CCI oscillates above and below a zero line. Normal oscillations tend to stay in the range of -100 to +100. A CCI reading of +100 may represent overbought conditions, while readings near -100 may indicate oversold territory. Although the CCI indicator was developed for commodities, it has become a popular tool for equity evaluation as well.
Moving average indicators are used widely for stock analysis. Many traders will use a combination of moving averages with different time frames to help review stock trend direction. One of the more popular combinations is to use the 50-day and 200-day moving averages. Investors may use the 200-day MA to help smooth out the data a get a clearer long-term picture. They may look to the 50-day or 20-day to get a better grasp of what is going on with the stock in the near-term. Taking a peek at some Moving Averages, the 200-day is at 0.24, and the 50-day is 0.15.
Dedicated investors may be looking to employ another tool for doing technical stock analysis. The Williams Percent Range or Williams %R is a technical indicator that was designed to measure overbought and oversold market conditions. The Williams %R indicator helps show the relative situation of the current price close to the period being observed. Elite Pharmaceuticals Inc. (ELTP)’s Williams Percent Range or 14 day Williams %R presently is at -73.33. In general, if the reading goes above -20, the stock may be considered to be overbought. Alternately, if the indicator goes under -80, this may show the stock as being oversold.
The Relative Strength Index (RSI) is a momentum oscillator that measures the speed and change of stock price movements. The RSI was developed by J. Welles Wilder, and it oscillates between 0 and 100. Generally, the RSI is considered to be oversold when it falls below 30 and overbought when it heads above 70. RSI can be used to detect general trends as well as finding divergences and failure swings. The 14-day RSI for Elite Pharmaceuticals Inc. (ELTP) is currently at 42.78, the 7-day stands at 41.86, and the 3-day is sitting at 31.9.
Nas,3 generic approval coming in 10 months or less!
10 months to go for-
15. Oxycodone HCl and Acetaminophen, USP 325 mg
5 mg, 7.5 mg, 10 mg Tablets
Percocet
Pain
Pending FDA Approval
Approximately 6 months to go for-
16. Hydrocodone bitartrate and Acetaminophine tablets, 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets
Norco
Pain
Pending FDA Approval
Probably in first quarter 2017-
17. Undisclosed Generic
Undisclosed
Undisclosed
Pending FDA Approval
Elite Pharmaceuticals Inc Shares Ready for Upside Breakout
(article date 11/13/2016)
Elite Pharmaceuticals Inc (OTCMKTS:ELTP) shares were up 1.29% on Friday to $0.152 and flat in after-hours trading. The company has a market cap of $111.45 million at 905.66 million shares outstanding. Share prices have been trading in a 52-week range of $0.11 to $0.42.
Elite Pharmaceuticals Inc is a specialty pharmaceutical company that is principally engaged in the development and manufacture of oral, controlled-release products. In particular, the company develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets generic controlled-release and abuse deterrent pharmaceutical products.
The company has two segments: Abbreviated New Drug Applications for generic products and New Drug Applications for branded products. It owns approximately six different approved ANDAs. Its product SequestOx is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates five milligram, 10 milligram, 15 milligram, 20 milligram and 30 milligram doses of oxycodone into capsules. It is used for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
In its earnings conference call, Elite Pharmaceuticals CFO Carter Ward summarized the results as showing ound operations, in line with expectations, strong financial position and a few items that will be significant to future financials. In particular, he is referring to the ANDA filing generic version of Percocet and the development agreement entered into with SunGen Pharma during the quarter. However, he mentioned that these future items aren’t reflected in the latest numbers yet.
In terms of the numbers, cash at September 30 was $12.6 million, up more than $1 million since the beginning of the year. Working capital was $14.5 million, also up $1 million during the quarter and is a $2.5 million improvement since March 31. He also highlighted the rise in inventory from $3.3 million at the beginning of the year to $5.6 million at September 30 and the fact that the balance sheet is no longer showing negative equity.
Gross revenues were $2.7 million for the quarter and $5.9 million for the past six months. Quarterly revenues are down 7% on a year-over-year basis but year-to-date and six-month numbers are up 17% compared to the same period a year ago due to shipment schedules. To be specific, Elite Pharmaceuticals had shipments that went in June and October, consequently not being factored in the September quarter. He added that their generic products Naltrexone, Phentermine, Methadone and Isradipine are performing well.
Also notice when you look at our revenues, we are consistently at an annual run rate above $10 million. This is further evidence of our financial showing that our generic business is providing the solid foundation. We say all the time it is one of the key components of our overall strategic plan,” Ward concluded.
R&D expense was $1.3 million for the quarter, and $2.8 million for the six months ended September 30, down $4.2 million and $6.6 million for the quarter and for the six months of 2015 due to the nature of their R&D activity. In the same time last year, their R&D was focused on SequestOx, a branded NDA product, and this year they are working on developing various generic products, both with SunGen and a few on their own.
As for P&L, Elite Pharmaceuticals reported quarterly operating loss of $1.2 million and a six month operating loss of $2.4 million, but explained that this should be viewed in conjunction with their R&D expenses.
The generic business is a net positive on our P&L. It covers our own costs. It covers its overheads, and it also provides contribution to the cost of product development,” he added.
Series of Elite approvals coming soon.
They have an undisclosed generic, generic Percocet, and Hydrocodone and Acetaminophen Combo.
GDUFA goal of eliminating backlog and speeding up approval has been steadily improving. Approximately 10 months now.
Link: https://www.americanactionforum.org/research/primer-generic-drug-approval-backlog/
The goal of GDUFA was to eliminate the ANDA backlog and reduce the average review time to ten months or less. The program has so far shown signs of success, action has been taken on 84 percent of the backlog, reducing it from 2,414 to just under 400 ANDAs, and newly submitted ANDAs will likely have average review periods of close to ten months.
GDUFA does prioritize some drugs over others, which may increase the anticipated review periods for certain classes of drugs. Generics that address ‘medical shortages’ may be fast-tracked. Likewise, where there is a lack of competition in the market (with only one manufacturer of a drug), first-entrant generics are also fast-tracked.
Stockboy, Elite may have been applying for years. We do not know as they would only PR receiving a grant. Gov grants are tied to budgeted funds so it is hard to get, BUT, with the 21st Century Cures Acts and its $1 billion in funding to combat the opioid addiction crisis there is new opportunities for ELTP!
21st Century Cures Acts will bring big investors to ELITE!
The Cures Act will ease the risks for investing in companies like Elite bringing big money from speculative investors!
The risk vs reward looks much better now!!!!!!!!
21st Century Cures Acts and its $1 billion in funding to combat the opioid addiction crisis through the U.S. House and Senate.
Elite will benefit huge from this Act.
Elite could even work to get government money for research and development!!!!!!!!
Senate clears bill to ease FDA drug and device approvals!
Elite's (ELTP) future looks a lot brighter now!!!!!!!!
SequestOx's approval more probable sooner!
Speed up of approval of ANDA's coming!
Quicker approval of Elite's coming abuse deterrent pipeline!
Elite future will develop quicker than most of us had hope for with the changes that are coming to the FDA!!!!!!!!
Shark, something interesting for ELTP, Nov 15, 2016 short sales is showing "0".... that is down from a high of Aug 15, 2016 showing
116,336.
Now, this is most interesting in that we have an OTC with a high float and low pps showing "0" shares short.... hard to believe.... things that make you go hmmmm!
Gabelli Convertible & Income Securities Fund still holding 1,080,296 shares of Elite Pharmaceuticals (ELTP) as of their September 30, 2016 report.
JMHO, but I think if they believed ELTP could not get SQUESTOX approved they would have dumped already.
Elite's SEQUESTOX approval could be as close as March 2017 if Elite does not have major hurdles or may be as are far out as September 2017 depending on time for fed BE study.
I believe it will be the sooner timeframe.
China connection....
Do your own DD and research but you have to recognize the potential....
NH said "Dr. Jim Huang is a good friend of mine"
Elite - SunGen - Jingjun “Jim” Huang - Ascendia Pharmaceuticals
Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Link - http://ascendiapharma.com/Leadership.html
dig deeper - very smart guy.... advance research in delivery tech, major connection back to billionaires in China.
Link to SUNGEN in China - http://www.strandbio.com/en/rd.php
Humanwell Puracap Pharmaceuticals - Wuhan Co. Ltd., located at Wuhan, China.
Do the google search and learn what you want.... I have seen enough and it is a great connection for ELTP.
Connect the dots.... China is big money and buying companies in the USA!
NH is definitely making amazing connections and friends that will help with technological development and financial partnerships and possible (some think probable) outright buyout!
Link to FDA resubmission policy
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082002.pdf
FYI - SEQUESTOX resub review timeline for the FDA
FDA Center for Drug Evaluation and Research (CDER)
CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
CDER will complete the review and act on Class 2 resubmissions within 6 months of the receipt date.
2
China’s $5 Billion Health-Care Deal Spree Shows Global Ambitions
(IMHO Note: It is important to consider that there may be things developing that we are not privy to. Additionally, China is ambitious to obtain U.S. drug market and manufacturing presence. Elite has developed connections with some of these Chinese companies and may benefit substantially!!!!!!!! It would be stupid to ignore this potential.)
When a branch of the Chinese army set up a medicine factory in 1939, it was intended mainly to help in the fight against the Japanese. It would later be used by Communist fighters during China’s civil war before evolving into a state-owned drug company.
Today, the facility is privately owned and on the front line of a different type of struggle. Its owner, Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd., has big ambitions to scale up and compete against Big Pharma firms around the world.
That means doing deals to break into markets from the U.S. to Africa or to bring international brands into China, said Shao Yan, chief executive officer of China Grand Pharma, in an interview.
“Even though China’s pharmaceutical industry is still in the middle of consolidation and price wars, we hope to escape from this and do more work in terms of innovation and internationalization,” said Shao, 53, who’s been CEO since 2008, and overseen a twelve-fold increase in the company’s revenue to more than $400 million last year.
Such a two-pronged strategy is typical among front-runners in China’s health industry today. Drugmakers are seeking an edge in the domestic market, where price competition is cut-throat. At the same time, they’re trying to upgrade from selling raw chemicals to exporting finished pills around the world.
Chinese companies have announced more than $5.2 billion of overseas health-care acquisitions this year, according to data compiled by Bloomberg, a fifteen-fold jump from 2012. Among the most prominent deals, Humanwell Healthcare Group, a Chinese maker of anesthetics and contraceptives, bought U.S.-based generic drug maker Epic Pharma LLC for $550 million. Shanghai Fosun Pharmaceutical Group Co., backed by Chinese billionaire Guo Guangchang, agreed to buy Indian drugmaker Gland Pharma Ltd. for about $1.3 billion, gaining drug factories that supply to the U.S.
Chinese drugmakers still face challenges making global deals because they are up against larger international rivals. Many are still unknown entities overseas and must prove to sellers that they have the financial wherewithal to close the deal. But if they succeed, consumers around the world can expect to see more and more “Made-in-China” drugs in their medicine cabinets.
Shao said his closely held parent company, China Grand Enterprises, has made international bids, including one for Swedish drugmaker Meda AB’s U.S. operations and another for the American generic drug business of Belgium’s UCB SA. At the time of the bidding process last year, people familiar with the matter valued those deals at about $1 billion each.
The Chinese company lost out in both instances. Mylan NV, which is run from Canonsburg, Pennsylvania, ultimately won Meda by agreeing to buy all of the company for $7.2 billion and Philadelphia-based Lannett Co. bought the UCB business. Shao said China Grand continues to look for other deals.
China’s exports of finished pharmaceutical products grew by 11 percent last year, according to industry groups. But that expansion came even as safety questions around some Chinese products have lingered, and as U.S. inspections uncovered violations at several factories. A drug application overhaul by the Chinese regulator last year turned up widespread problems of incomplete and fraudulent data.
While some Chinese companies have been pulled up by regulators, others say they have taken measures to boost standards. China Grand Pharma mainly aims to export finished drugs to developing markets and hasn’t faced regulatory actions from the U.S. or European drug quality watchdogs, according to the company.
Meanwhile, a string of smaller Chinese firms are also seeking to become bigger suppliers to Western multinationals, and are trying to forge international deals to boost this side of their business.
Tucked away in China’s southwestern Chongqing metropolis, Porton Fine Chemicals Ltd. which employs about 1,600 people and had about $162 million in revenue last year, supplies chemical components that are used in HIV and hepatitis drugs worldwide. Porton in its annual report says it serves 16 of the world’s 20 largest drugmakers, and mainly supplies to two major clients, Johnson & Johnson and Gilead Sciences Inc.
While Chinese companies have long been a source of ingredients for generic drugs, multinationals have largely sought to control the supply chain for the newest medicines, Ju Nianfeng, chairman and co-founder of Porton said. Ju hopes to break into this area by acquiring established manufacturers of pharmaceutical ingredients in Europe and the U.S.
“Clients prefer to source from Western companies which already have better track records,” said Ju. “It will take us time to build such trust and track records.”
Even with a willingness to pay up, Chinese companies haven’t always succeeded in nabbing the most attractive overseas assets. In an e-mail, China Grand Enterprises, the parent company, said that when it sought to buy the UCB generics business, the seller was concerned about uncertainties related to national security screenings of foreign buyers in the U.S. UCB declined to comment.
The listed company Shao oversees is looking for assets worth $100 million to $500 million focused on eye treatments and cardiovascular drugs. Meanwhile, the parent, which owns businesses ranging from real estate to financial services, continues to scout for U.S. deals, potentially using the Hong Kong traded unit and partnering with private-equity firms, Shao said.
His company bought a 33 percent stake in a small German maker of cardiovascular devices called Cardionovum GmbH last year, and hopes to bring its products to China by 2018.
“We’ve been through three or four cases, one succeeded and two did not,” said Shao. “These are special stories about Chinese companies trying to do overseas M&A, and they’re a learning process.”
SunGen Pharma Graduates from CCIT
http://njbmagazine.com/njb-news-now/sungen-pharma-graduates-ccit/
Elite partner on a successful path.
Goodtimes.... not sure as to why. Maybe putting it out there before some short promoter tries to use it as damaging news to drive the stock down.... or maybe Nasrat (Pres/CEO) is just being total transparent.... maybe excessively transparent.
If the FDA could only find a step missing from a PADE procedure during their inspection then I would say that Elite is doing good.
Based on my professional experience as a federal government employee, most of the time this is just an difference of opinion as to what the procedure must have in it.... inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says it must say XXXX and owner says but it says that here.... and the inspector says....
Just send me a letter and I will fix it.
Hahaha, played this game before.
JAZZ got a PADE warning letter in 2011 and now they are worth $123 per share.... haha, come on up ELTP!
Search it.... FDA warning letters
They are written frequently, typical of any inspection by a government agency. They have 15 days to send a letter of action taken and then it is pretty much done.
Do a little research.
Elite and SunGen news showing on PharmaAsia website (Voice of pharmaceutical manufacturing).
Need is getting around the world.
Also seeing it on Deutsche sites in Europe.
Elite and SunGen partnership may be connected due similar technologies and further benefits of sharing expertise for solubility/dissolution improvement and advancing nano/micro-particle technologies.
That would explain partnering with a startup company that has advanced knowledge and experience with more advanced tech!
The stock of ELITE PHARMACEUTICALS (OTCMKTS:ELTP) registered an increase of 367.07% in short interest. ELTP’s total short interest was 116,300 shares in August as published by FINRA. Its up 367.07% from 24,900 shares, reported previously.
Haha, I think this is why some are upset! They were not expecting the SunGen news and it is running higher and they do not want to cover their short position.
ELTP is not traded on the Shanghai stock exchange.
Investors from China would work with associates here in the USA.
Elite - SunGen - Jingjun “Jim” Huang - Ascendia Pharmaceuticals
Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Humanwell Puracap Pharmaceuticals - Wuhan Co. Ltd., located at Wuhan, China.
Connect the dots.... China is big money and buying companies in the USA!
Elite - SunGen - Jingjun “Jim” Huang - Ascendia Pharmaceuticals
Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Humanwell Puracap Pharmaceuticals - Wuhan Co. Ltd., located at Wuhan, China.
Connect the dots.... China is big money and buying companies in the USA!
Elites links to China market are growing....
Ascendia Pharmaceuticals - Established in 2012 by Jingjun “Jim” Huang - Ascendia has also opened a subsidiary in China in late 2014 to serve formulation development needs of the Chinese market.
Chinese investors coming to ELTP!
Could be a new wave of investors coming into Elite. Connections with PuraCap and now SunGen!
Everything will be falling into place for Elite and the money will come in the 100s of millions $$$$$$$$
BUY! BUY! BUY! When others are screaming sell, sell, sell - that is a sure sign to BUY!!!!!!!!
Buyout by Pfizer would be a smart business move. Remove completion! Get generic Percocet and advanced research on a new state of art ADF technology!
How many MILLIONS $$ ??
With Pfizer's FDA Approval of TROXYCA(R), how many $$ millions does that save Elite?? I know Hakim said Pfizer's approval said that it would save Elite a lot of R&D funds but I cannot remember how much he said. Anyone??
N2K,lasers, question??
So we can safely assume that Elite has already been talking by phone with the FDA.
We know they are working solutions with Camargo Pharmaceutical Services and will present 3 options during meeting with FDA.
Is it possible that they can receive approval at that point or will they need to do a resubmittal??
Just trying to guesstimate the timeframe - 30 days from written meeting request for actual meeting - if resubmittal is required then FDA has 60 day review period from the date of that resubmittal.
I am long and looking to buy more so if we have some time I will get these bargain prices before the run. Picked up another 60,000 shares last week. I will continue to buy under 0.35 until SequestOX approval and I am closing in on my goal of over 500K shares quickly.
Just a couple more buys and I am there!
FDA resubmittal for SequestOX 2 month review.
Here is the process - probably will be a Class 1.
The review team and division director will determine whether the resubmission constitutes a complete response that addresses all deficiencies in the complete response letter. If so, the review team and the division director will classify the resubmission as Class 1 or Class 2.2
? The regulatory project manager will issue a letter to the applicant within 30 calendar days, acknowledging receipt of the resubmission.
? If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, CDER will inform the applicant in the letter and the review clock will not start until a complete response is received.
? If CDER agrees the submission constitutes a complete response, the letter will state the classification and provide the due date for action.
? CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
Class 1 Resubmission — A resubmission that includes one or more of the following items:
1. Final printed labeling
2. Draft labeling
3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)
4. Stability updates to support provisional or final dating periods
5. Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
6. Assay validation data
7. Final release testing on the last 1 to 2 lots used to support approval
8. A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
9. Other minor clarifying information (determined by CDER as fitting the Class 1 category)
Elite Pharma is going after the money makers in the generic pain drug lineup! Smart business tactic, get revenue generating generic line to fund R&D.
Elite will get SequestOx through this slight delay and have their flagship drug generating revenue also.
I feel good about my investment here and expect Elite will give me a significant return in the next few years as I am an INVESTOR and not a flipper.
Percocet revenue of $135,822,000 for Endo for year ending 2015.
So, if Elite ELTP get even a small percentage of that type of revenues they will be good. Good market to go after!
Should FDA pull OxyContin, Roxicodone, Oxaydo or any IR oxycodone since they would now have the same SAFETY concern as SEQUESTOX????
That should be a question that ELITE asks during their meeting with the FDA.
Review the labels on the 3 drugs above.... things that make you go Hmmmm!!!!
LPC funding and registration of shares make sense now!
IMO, The prospectus filed was not associated with SEQUSTOX or the cost of additional study. IT WAS FOR THE 6 ADDITIONAL FILINGS COMING IN THE NEXT 6 QUARTERS!!!!!!!!
What we know from the CC today is that the TECH is sound/valid so ELITE can proceed with the additional pipeline drugs and file NDAs.
The FDA CRL was educational and ELITE learned from it! Now they need to money for the additional filings.
I am good with that, the additional shares is miniscule compared to the revenues generated by the 7, that is right - SEVEN - SEQUESTOX AND THE 6 MORE COMING, new abuse deterrent drugs they will have on the market within the next 2 years!
Should FDA pull OxyContin, Roxicodone, and Oxaydo since they would now have the same SAFETY concern as SEQUESTOX????
That should be a question that ELITE asks during their meeting with the FDA.
Review the labels on the 3 drugs above.... things that make you go Hmmmm!!!!
No 30 day clock for a meeting with the FDA!
Reviewing the regs and cannot find any restriction saying you cannot meet with the FDA for 30 days.
They can have a meeting as soon as a date is available so it could be days or weeks depending on the FDA's calendar.
I lay odds since ELITE said they would know more in August that it will be a couple of weeks for an opening.
LPC funding and registration of shares make sense now!
IMO, The prospectus filed was not associated with SEQUSTOX or the cost of additional study. IT WAS FOR THE 6 ADDITIONAL FILINGS COMING IN THE NEXT 6 QUARTERS!!!!!!!!
What we know from the CC today is that the TECH is sound/valid so ELITE can proceed with the additional pipeline drugs and file NDAs.
The FDA CRL was educational and ELITE learned from it! Now they need to money for the additional filings.
I am good with that, the additional shares is miniscule compared to the revenues generated by the 7, that is right - SEVEN - SEQUESTOX AND THE 6 MORE COMING, new abuse deterrent drugs they will have on the market within the next 2 years!