Monday, November 23, 2015

"10 REASONS ELTP IS IN THE MIDST OF A PERFECT STORM"

Couch	Monday, 11/23/15 09:25:46 AM
Re: None
Post # of 173739

10 REASONS ELTP IS IN THE MIDST OF A PERFECT STORM AND A GREAT BUY NOW $$$$$$

1) ELITE is about to put out the BIGGEST PR in the company's history in JANUARY or sooner.

Quote:
As of today our focus remains on ELI-200, on filing it by the end of this year and when I say this year I mean our calendar year meaning December of 2015, by the end of December 2015. We will make an announcement once we receive acceptance of the filing by FDA which most likely will be the first or second week of January unless FDA act faster. So we will file once we receive an acceptance from FDA, we will either issue a press release so have conference call, most likely we'll issue a press release.

2) ELITE is scaling up a SECOND manufacturing line and installed a VAULT to store ELI 200.

This means Elite is capable of launching ELI 200 with its current equipment PLUS a few additional ADT products! PLUS Nasrat plans to file 2 additional NDAs in 2016.

Quote:
We are a DEA control facility we have two vaults presently one for the R&D and one for commercial and we have just finished installing a very large vault in anticipation of the launch for ELI-200.

We have installed a second packaging line and we are very close to finishing the construction so we can start the validation and scale up activity. A small note on that. [color=red]The current equipment we have our [GLAS60] would be capable of launching initially ELI-200. Once we activate the new facility then we will have the capability to launch multiple products.[/color]

3) ELITE plans on expanding and beefing up its GENERIC pipeline!!

Elite is currently Cash Flow Positive (CFP) on its operations minus R&D costs and cutting into those R&D costs slowly and surely quarter by quarter! Nasrat stated previously he would go out and buy additional ANDAs worth way more than the existing generic products.

Quote:
So what that means is our generic operations are cash positive and as you know that is another key element of our long-term strategy.

Quote:
So we’re achieving the growth and the profitability required from generics, at the same time, we also developing [align] of our abuse-deterrent opioid, those are two major plans of our strategy and we’re hitting on both of them or we can check both of those off so far.

Quote:
Third the generic product launch, we've launched Phendimetrazine, Isradipine, Hydroxyzine and currently Epic is working on filing Loxapine and Dantrolene by the end of Q1 of 2016. We are working on beefing up our generic pipeline and you will see that happening more in 2016 and hear more about it in 2016.

4) 5 states already passed laws to REQUIRE insurance companies to pay for Abuse Deterrent Opioids. Florida and Ohio could be next as the powers that be are pushing to pass ADT laws in most states.

1) Colorado
2) Utah
3) Maine
4) Maryland
5) Massachusetts

http://abusedeterrent.org/news/Portman-Calls-on-Administration-to-Halt-Harmful-Opioid-Rule.aspx#.VlGpAng3-FI

5) Even with existing pressure on lawmakers to pass abuse deterrent opioid laws, Medicare is showing that it still prefers to pay for cheaper generic non ADT opioids and will do so until forced otherwise.

http://khn.org/news/medicare-drug-plans-favor-generic-opioids-over-those-designed-to-avoid-abuse-study-finds/?utm_campaign=KHN%3A+First+Edition&utm_source=hs_email&utm_medium=email&utm_content=18294693&_hsenc=p2ANqtz-83L8HtGq_OQ-mrezx46wvS6SkU0JKQgFVptr05XwnylCv5_y4RfdVdC-bAopFmm0hNVw9GZKlpHKxTfEeWHpXIv3mbAQ&_hsmi=18294693

Quote:
The coverage decisions “suggest that the Part D plans are not considering abuse deterrents as any meaningful part of the coverage decision,” says Caroline Pearson, a senior vice president at Avalere and co-author of the study.

OxyContin is significantly more expensive than generic hydrocodone. A 120-day supply of generic hydrocodone might cost $28, according to Healthcare bluebook, which estimates prices based on a nationwide database of payment data. [A similar prescription of OxyContin, on the other hand, might cost $632, more than 20 times the generic price.

Elite has an answer for this problem as well! It's called ELI 300 and ELI 301. Elite's 2 generic ADT opioids.

http://www.elitepharma.com/pipeline-generics/

6) Once the various states insurance covers abuse deterrent opioids and ELI 200 gets approved, here is EXACTLY why Elite will steal HUGE revenues from the competition. Physicians like Elite's ADT best.

Quote:
Physicians call for novel abuse-deterrent opioid agonist/antagonist formulations in survey

http://www.fiercedrugdelivery.com/story/physicians-call-novel-abuse-deterrent-opioid-agonistantagonist-formulations/2015-11-09

A survey of more than 200 physicians found that 31% think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic--an issue that's been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree.

What type of abuse- deterrent formulation is most needed?

Number (out of 214 respondents)

Opioid antagonist/agonist combination 66 (31%)
Physical or chemical barrier 48 (22%)
Novel delivery system 34 (16%)
Aversion 33 (15%)
Prodrug 14 (7%)
Other or combination of above 19 (9%)
FierceDrugDelivery supplied the question to Quantia MD, the provider of a physician engagement platform that counts one-third of U.S. doctors as its members.

Out of 214 physicians, 66 said opioid antagonists/agonists are the most needed formulation. Opioid antagonists are substances that interfere with the euphoria associated with drug abuse. The deterrents would generally be released and activated only if the product is manipulated, such as during crushing or snorting.

7) Should Elite's ADT prove to be highly effective there is a chance that the FDA would pull all other non ADT opioids off the market in that particular opioid class. Notice from the article link provided below there is considerable pressure being placed on the FDA to follow through on this very possibility.

Quote:
"Under its existing regulatory authority, FDA has the ability to remove generic formulations that lack abuse deterrent characteristics from the market, when the additional relative safety of a new formulation of a medication with abuse deterrent properties is available," PhRMA and BIO continued. "We encourage FDA to exercise its authority to continue to protect the public health. FDA should incentivize the development of abuse deterrent formulations, which is in the best interest of patients."

http://raps.org/Regulatory-Focus/News/2015/01/20/21120/Should-FDA-Pull-Non-Abuse-Deterrent-Generic-Opioids-off-the-Market-PhRMA-Bio-Say-Yes/

8) The global market for pain management is growing exponentially and currently sits around $60 billion. Further, the largest segment of this financially is the pharmaceutical industry. Given the aging of our population this number will only continue to grow year after year.

http://www.prweb.com/releases/2011/1/prweb8052240.htm

9) Elite has very similar abuse deterrent technology (ADT) to Pfizer who is the Market Leader in Global Pain Treatment. As Nasrat has said let Pfizer educate the doctors, insurance companies and the public at large about their ADT opioids and Elite will ride their coattails.

http://www.fiercebiotech.com/press-releases/pfizer-market-leader-global-pain-treatment-market-companiesandmarketscom

Further, when the likes of Pfizer and Purdue begin paying to conduct research and public educational studies related to ADT opioids one knows ADTs are the wave of the future.

http://avalere.com/expertise/managed-care/insights/medicare-drug-plans-favor-generic-opioids-that-lack-abuse-deterrent-propert

http://www.teamagainstopioidabuse.com

10) *****My Personal Favorite is Elite will IMO be partnering with a BP for ELI 216 and that whoever this company is stands a SOLID chance of BUYING ELTP out altogether in 2017.

Sunday, November 22, 2015

$ELTP VITAL SIGNS

Elite Pharmaceuticals appears to be getting closer to their goal of profitability. Of course the "filler" drugs they have been selling have been solid enough to help the company get there while Elite's bigger drug developments achieve their incremental benchmarks.... Meanwhile take a look at the Co. snapshot:

cash: $9 million

current liabilities: $4.5 million

quarterly revenues: $2.6 million

quarterly net loss: $1.9 million

Monday, November 9, 2015

$ELTP Has a Conference Call Tuesday, November 12, 2015

Currently trading at a $274 million market valuation ELTP does have $11 million in the treasury, manageable debt and fast growing revenues reporting $7,079,772 in sales for the 3 months ended June, 30, 2015. The stock has fast quickly become an Investors favorite; ELTP is fully-funded moving forward, the Company has nineteen FDA approved drugs to be manufactured, approximately eighteen more in the pipeline in various stages with numerous partners, and just announced positive top-line results from the Phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain.

MORE HERE

Friday, November 6, 2015

The $ELTP Pump n Dump Argument on Ihub is Absurd

Because we are an UNOFFICIAL $ELTP blog, we have the luxury to post information from all sorts of venues. The best bang for the buck tho happens to be the ongoing hit parade on Ihub, where the list of investors following the company has dramatically increased in the days since I first invested in winter of 2010.

dr_lowenstein
I see, well I never suggested it was a scam. Do you think it is a scam?

Aqua
No sir, actual pump-and-dumps are scams. But there are instances in which investors create a pump-and-dump opportunity. Allow me to use Apple Inc. as an example. We all know the PPS is pumped before earnings and then dumped right after. Does that make Apple, Inc. a bad company for shareholders to profit in the end?

Cheers!

dr_lowenstein
as I said, I never described the company as a scam. are you saying that you think it is?

Wasn't the answer "No sir, actual pump-and-dumps are scams."? Not sure what what to call your line of questioning that you use (often) but it sure appears masturbatory the way you badger (often). $ELTP has seen peaks and valleys though neither their highest peak nor their lowest valley give a proof positive signal of pump-n-dump, in this blogger's estimation.

If P&D is synonymous with "scam" than you most certainly have made this claim endless times. Have you said the word "scam"? Well you've used P&D countless times.

How does a pump and dump scam work?

By Investopedia Staff AAA |

A: A pump and dump scam is the illegal act of an investor or group of investors promoting a stock they hold and selling once the stock price has risen following the surge in interest as a result of the endorsement.

Penny stocks are ripe for pump-and-dump scam

Pump and dump

From Wikipedia, the free encyclopedia

The "night singer of shares" sold stock on the streets during the South Sea Bubble. Amsterdam, 1720.

"Pump and dump" (P&D) is a form of microcap stock fraud that involves artificially inflating the price of an owned stock through false and misleading positive statements, in order to sell the cheaply purchased stock at a higher price. Once the operators of the scheme "dump" sell their overvalued shares, the price falls and investors lose their money. Stocks that are the subject of pump and dump schemes are sometimes called "chop stocks".^[1]

Pump And Dump

DEFINITION of 'Pump And Dump'
A scheme that attempts to boost the price of a stock through recommendations based on false, misleading or greatly exaggerated statements. The perpetrators of this scheme, who already have an established position in the company's stock, sell their positions after the hype has led to a higher share price. This practice is illegal based on securities law and can lead to heavy fines.
The victims of this scheme will often lose a considerable amount of their investment as the stock often falls back down after the process is complete.

^{Conclusion: Am I with pumpers? Hell no. Am I rooting for $ELTP, hell yes. Do I KNOW this will hit $1 ? Uhm, I cannot predict the future and neither can anyone else - but am I using fear tactics to get my point across? There does not seem to be a need for that, even at $.41 cents a share, you just never know. Masturbate away, ol' chap!}

Thursday, November 5, 2015

IHUB's Thought of the Day on the Heels of Recent $ELTP PPS Surge

Steges	Thursday, 11/05/15 07:49:29 PM
Re: None
Post # of 170662

Elite is up 60% so far this week. I'm not sure how anyone could call this anything other than folks are finally starting to realize that this is a real company with a blockbuster product line that is less than 10 months away from commercialization on the first of many abuse resistant opioids and has been largely under the radar to the investment, medical and pharma industries.

Just as illustration. When I attend medical conferences with preeminent thought leaders on pain and addiction, nobody knows about Elite. When we meet with our congressman and senators (the same members actually writing and submitting legislation to combat opioid abuse and call for ART/ADT mandates) they don't know about Elite. Now some might spin that as a negative, that Elite must not have anything special if nobody knows about them. Fair enough, let the PPS and material events be the scoreboard on that as we enter into this maturation period for Elite. This technology cannot be spun and a lot of these thought leaders, politicians, clinicians and pharma folks are going to either know Elite's name or see Elite's technology branded by one of the major household pharma companies over the next couple years.

I have owned this stock since 2004 and never felt more confident in the future. There have been some major ups and downs and a couple times it seemed like bankruptcy was inevitable. There is not need to dwell on the past, to get frustrated by how poorly the company was managed and think with bewilderment how it could have actually taken this long to get to this point, but rather, focus the attention firmly on the future. The reality is that this might be the only company any of us ever invest in that rewards us with such an outrageous bounty.

Since it seems like a lot of new investors are finding out about Elite, I implore you to do your own due diligence... read Elite's press releases and SEC filings. Note the individuals who have joined this company over the last couple years - they have significant pharma experience at some of the biggest and most successful companies in the industry. These folks do not leave the aforementioned companies to work at a little pharma company in Northvale, NJ - it just doesn't work that way.

I initially invested in Elite because of their delivery system, it's simple and brilliant. As an emergency physician day in and day out we grapple with appropriate pain management and responsible prescribing. There is no silver bullet but Elite's technology is incredible and there has never been a more pivotal need for it. I have seen some individuals post on this board that it is "a perfect storm" and I couldn't agree more.

Elite will not be the only company with ART/ADT opioids, if anyone thinks that it's categorically wrong. There are a few companies -- who like Elite -- show exceptional promise. The takeaway is that only a few will exist in a multi-billion dollar market.

It's almost beyond the realm of reality to think that any of us could invest in this company at its current price per share.

Wednesday, November 4, 2015

$ELTP Conference Call Next Week - Here's Some Potential Questions for Mgmt

**** Elite Pharmaceuticals Conference Call Questions ****

Those participating in ELTP’s Conference Call Q&A session are limited to asking one question following ELTP management’s opening statements. To make the most of this Q&A opportunity, suggest that we come up with a list to share of top questions to ask:

(Copy/paste the latest posted list and add your question(s) at the end of the list)

1. Any plans for ELI-154?

2. Now that the NDA filing is very near to completion, what are the status updates on ELI 201 and 202? Has the FDA given any indication (or have they been asked) about reduced trial requirements for ELI products that are similar to ELI 200? HAL studies and Phase 3s required for every single product?

3. Update on ELI-202 BE?

4. Any generics moving up the ladder to commercialization?

5. Elite had an agreement with Epic for 8 drugs where Elite gets a 15% profit split. Elite is no longer proceeding with the last 7 drugs. However, the first and only drug has been filed with the FDA for 3 1/2 years now and we haven't heard anything. Do you have any updates on this?

6. Are there any numbers yet on the sales of Isradpin?

7. Status update on the arbitration of Phentermine with Precision Dose?

8. Given Elite's generic NDA ART line takes less time and money to bring to market than Elite's once daily Eli 216 product, what are the current plans for this product? How likely is it to partner a combo Eli 201 and 216 together? How quickly are you planning to move forward with this product since there is no other once daily abuse resistant product on the market?

9. What is the up to date information on the Public Float and Shares Outstanding for ELTP?

10. Given Nasrat's experience working at Alpharma and Actavis... Does he think Elite's patents are different enough from Purdue not to move toward legal avenues? If not, does Nasrat believe royalties fees would be the end result for Elite?

11. How does Elite's ADT compare to other ADT products that purport to detour swalling a handful of pills? What would it take to get Elite to attach "similar" ADT. How does Elite's microtablet technology improve on Elite's existing ADT? What is the microtablet technology worth once Elite begins to market its ADT opioids?

12. Did Epic ever settle with Purdue?

13. Does Epic have plans to ramp up sales and marketing departments in anticipation of marketing ELI-200 or future ART drugs?

14. What are the chances of an Epic and Elite merger? What would a reverse merger do to the PPS?

15. What's the current status of Mikah and the relation between Mikah/Epic as well as any possible conflict of interest that relation can cause to Elite?

16. Will there be a new valuation/assessment?

17. Will there be any Pie Charts to show shareholders the increase in shares?

18. We seem to have been "flying under the radar" for quite awhile now. Does Nasrat plan on presenting at more conferences (Rodman and Renshaw and others) to promote awareness and interest in the company now that we are in the last stretch for ELI 200?

19. Since EPIC is going to be marketing its own ER ADT OXY and Elite's IR ADT OXY at the same time, which ADT will Epic be using.....Will it be a hard turtle shell version like Purdue/Actavis has agreed upon.......OR is EPIC going to be using a version of Elite's ADT?

20. What are the scenarios/circumstances that would engage Elite to pursue up listing to the Nasdaq or anything comparable?

21. The annual shareholders meeting - Status update?

22. What is the rational/need for issuing additional shares to Lincoln Park in light of the revenue that will be gained from the recent licensing agreement with Epic? If the goal is to uplist to Nasdaq, doesn't the continued issuance of shares impede this goal?

23. Status update on the new fluid bed dryer.

24. Regarding EPIC's Oxycodone Generic. Is it strictly EPIC's ANDA product? Did Elite help to develop EPIC's Oxycodone?

25. Elite requested and was granted accelerated filer status by the SEC. Why did Elite want to be an accelerated filer?