Thoughts On Conference Call 11102017

My initial thought is this.  When the stock was in more solid footing, at .24 cents a share we heard Hakim (Mikah) inform us that we were going to be at a dollar "in a couple years" and today as we sit at .08 cents a share a couple years later he wants to sit there and tell us that "in a couple years" we will get to, as he playfully puts it: "dollar-land."  He also dismisses claims this is going to .02 cents anytime soon.

Ok, and he did lay down a lot of ways to get there so why the worry?  Look how the fans react:

snupoled	Friday, 11/10/17 12:24:31 PM
Re: CMDawg post# 276878
Post #  of 276935

cm,

He in fact dunked it right in the face of ihub posters

regarding warrents,series j, and linc.

oh my,

that spin move to the hoop was WOWWWWWW, ZZZZZA

HOW DO YOU DEFEND THE GOAL POST,,,,

PFIZER reps HAve BEEN CALLED ON DA MAT.
launch our comparator, 2 years left on exclusivity man!

snupDAWGoled 

and...

Hutch321	Friday, 11/10/17 12:27:26 PM
Re: snupoled post# 276889
Post #  of 276935

Agreed. Great call today. Best we've had in a while. Loved it that Nasrat put to bed the "bologna" that some post here continually day in and day out. Long and strong. 

and

rocioyogi	Friday, 11/10/17 12:48:28 PM
Re: rocioyogi post# 276888
Post #  of 276936

This thing should be flying right now seaQuest Ox will be approved next year should have science resolved before next conference call within a couple months he said real close if not they think they can get the labeling done others are following a long everything is great I am buying all I can over the next few months 

8 cents, Hakim!  8 CENTS!!

ELTP stock trading LOWER and LOWER As Nasferatu Sharpens Teeth

Trick or Treat? 

Nasferatu awaits...

Time For ELTP Commentators To Address Problems

Mazeppa	Thursday, 10/26/17 02:44:34 PM
Re: None
Post #  of 275031

So, given Nasrat kept the warning letter a secret until his hand was forced, will he keep it a secret if it is rejected again and the same process ensues?

Couch, not to be picky, but frankly I am really confused as to what point are you trying to make with the ongoing banter of having called a 10-bagger like 3-4 years ago...why does that matter now? We are now at .08-.09, so I do not see any reason of such effort worthy an endless argument over such a call, which for the record I believe you did make, but don't see how it is relevant now and the banter unproductive. I think I am missing your point, but would ask you clarify what it is because I have very limited time to go through the posts. I am not "getting" what you are trying to express and certainly wish to do so if it is important with respect to why I should keep holding this. Seems like there are a lot of other companies right now doing quite well and losing on the opportunity cost of holding. TIA.

On a more important issue, as the sp is simply the market cap divided by number of OS, while .088 looks "undervalued" the real question of valuation is whether the company is worth the current market cap or not. Currently, SequestOx is doing nothing, the ANDA's are just sitting around not being assessed, the warning letter is unresolved and just hanging up everything, the SunGen "partnership" has so far resulted in nothing at all (as with Pura), and the company is operating at a small loss, thus likely diluting more. What justifies a market cap of more than 70m? Even at .15, that implies a market cap of 140m or so (not trying to be exact), so why would such valuation be appropriate at this point? Unfortunately as a long, as of now, I see nothing that leads me to believe a .15 sp is justifiable right now. Yes, if some of the "DollarLand" prognostications come through, but so far everything has failed or stalled in limbo.

Can anyone tell me, or post a link, to where Nasrat was called "The Closer" when at Activis, or is it an urban board myth? I thought he was a QC guy...QC guys don't close anything. Nasrat lied by omission about the SOx t-max, and again about the warning letter and its impact. What is with the pedestal people seem to put the guy on?

GLTA as usual--enjoy my days more when I don't check the sp it seems, unfortunately,

Maz 

As a point of reference also note they released the JFK files today, so have at conspiracy freaks!

Ihub Post Of The Day

Couch	Sunday, 10/22/17 07:28:39 AM
Re: stockboy post# 274544
Post #  of 274587

10 FACTS of LIGHT leading to DOLLARLAND = $$$$$$$$$ 

1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.

our business is moving away from this type of revenue stream that is dependent on third parties.

2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.

The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.

3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.

4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.

5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation

6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.

7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.

8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.

9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.

10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches. 

Here's A Theory As To Where Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Is Going With Generic OxyContin

Elite Pharmaceuticals Inc (OTCMKTS:ELTP) just announced its submission of an abbreviated new drug application (ANDA) for a generic version of extended-release oxycodone hydrochloride.

Some reading may already be familiar with this drug by way of its commercial name, OxyContin. Others may also be familiar with the difficulty that a number of other companies, most notably Epic Pharma, which was acquired by PuraCap back in March last year for around $550 million, had with their respective attempts to do what Elite is trying to do right now.

Read the rest HERE

Charting Sinking ELTP

                                              2-year ELTP chart

Predictions by some of the bashers on iHub have been eerily coming to fruition as the Elite Pharma team silently works out various concerns.

However, the company has been profitable and if some of the issues get worked out there could be a nice rebound.  Investors wait for the time, but at .092/share, there is reason for concern.

ELTP really needs some positive FDA news, but every day seems more and more difficult to trust.

That was one long summer...

Now all that's left is a .10$ stock...  what has happened?  Nothing!

Nasrat's tenure has turned sour, and there has been no news, nothing!  But don't take my word for it, listen to the posters on the Ihub board:

jour_trader	Sunday, 09/17/17 02:59:39 PM
Re: Couch post# 271030
Post #  of 271088

Well, the PPS has gone nowhere but down recently. I wonder why?! 

Couch	Sunday, 09/17/17 03:08:35 PM
Re: jour_trader post# 271035
Post #  of 271091

Gee again the PPS was .068 when Nasrat became CEO - the stock is highly undervalued at this point in time on the generics pipeline alone. 

There are folks who are looking at the prospects of a better future.  One where going sub-zero will be avoided... look at this impressive list.  Nasrat, hopefully, is listening...

NASDAQ2020	Sunday, 09/17/17 04:12:32 PM
Re: None
Post #  of 271093

Elite's Multi-Billion Dollar Platform: 
Short to mid term products are entering an IMS market value
of $6 + Billion Dollar$
Bright future ahead for ELTP
Elite's Current Marketed Products and Pipeline is growing rapidly ! Fully developed its worth Billion$
Start watching for the undisclosed drug filings.
$$$$$$$$$$$$
Elite working on 7 AD opiods concurrently

$Generic Products$$

Commercial Product
Branded Product Equivalent
Therapeutic Category

1. Hydromorphone Hydrochloride
8 mg Tablets
Dilaudid®
Pain

2. Naltrexone Hydrochloride
50 mg Tablets
Revia®
Opioid Antagonist

3. Phentermine HCl
37.5 mg Tablets
Adipex-P®
Bariatric

4. Phentermine HCI
15 mg and 30 mg Capsules
Adipex-P®
Bariatric

5. Phendimetrazine Tartrate
35 mg Tablets, USP
Bontril®
Bariatric

6. Isradipine
2.5 mg and 5 mg Capsules
N/A
Cardiovascular

7. Hydroxyzine HCI
10 mg, 25 mg, 50 mg Tablets
Atarax®, Vistaril®
Antihistamine

8. Dantrolene Sodium
25 mg, 50 mg and 100 mg Capsules *
Dantrium®
Skeletal Muscle Relaxant

9. Loxapine
5 mg, 10 mg, 25 mg, 50 mg Capsules *
N/A
Antipsychotic

10. Additional Approved ANDA's *
Undisclosed
Undisclosed
* pending manufacturing site transfer

11. Trimipramine

$BRANDED PRODUCTS$$
Commercial Product
Therapeutic Category
Partner

12. Lodrane D®
OTC Allergy
Valeant Pharmaceuticals International, Inc.


$CONTRACT MANUFACTURING$$
Commercial Product
Branded Product Equivalent
Therapeutic Category
Partner

13. Methadone Hydrochloride
10 mg Tablets
Dolophine®
Pain
Ascend Laboratories, LLC


$GENERIC PIPELINE$$

Programs Under Development
Branded Product Equivalent
Therapeutic Category
Development Stage

14. ELI-300 Opioid
Undisclosed
Pain
Early Development

15. ELI-301 Opioid
Undisclosed
Pain
Early Development

16. Oxycodone HCl and Acetaminophen, USP 325 mg
5 mg, 7.5 mg, 10 mg Tablets
Percocet
Pain
Pending FDA Approval

17. Hydrocodone bitartrate and Acetaminophine tablets, 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets
Norco
Pain
Pending FDA Approval

18. Elite/SunGen Generic #1
Undisclosed
CNS Stimulant
In Development

19. Elite/SunGen Generic #2
Undisclosed
CNS Stimulant
In Development

20. Elite/SunGen Generic #3
Undisclosed
Beta-Blocker
In Development

21. Elite/SunGen Generic #4
Undisclosed
Beta-Blocker
In Development

22. Elite/SunGen Generic #5
Undisclosed
Anti-depressant
In Development

23. Elite/SunGen Generic #6
Undisclosed
Antibiotic #1
In Development

24. Elite/SunGen Generic #7
Undisclosed
Antibiotic #2
In Development

25. Elite/SunGen Generic #8
Undisclosed
Antispasmodic
In Development

26. Generic Troxyca
Pain

27. Generic Embeda
Pain

28. Generic OxyContin

29. Generic Opana Oxymorphone
Pain


$BRANDED PIPELINE$$

Development Stage
Partner

30. $equestOx™ (ELI-200) Opioid
Pain
NDA Submitted
PDUFA date: July 14, 2016
Epic Pharma LLC

31. ELI-201 ER Opioid
Troxyca equivalent
Pain
Pivotal Bio-equivalence

32. ELI-202 Opioid
Pain
Pivotal Bio-equivalence

33. ELI-216 Opioid ER 24hr (once/day)
Pain
Process Development

34. ELI-400 Opioid
Pain
Process Development

35. ELI-500 Opioid
Pain
Process Development

36. ELI-501 Opioid
Pain
Early Development

37. ELI-600 Opioid
Pain
Process development ELTP

38. Chinese ADF opiod

39. Canadian ADF opiod

40. European ADF opiod
$ELTP


ELTP 

Elite Pharmaceuticals, Inc. to Host Conference Call to Discuss Financial Results on June 15, 2017

NORTHVALE, N.J., June 13, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP), a specialty pharmaceutical company developing a pipeline of abuse-deterrent opioids and niche generic products, announced today that its 2017 year-end financial results will be released on Wednesday, June 14, 2017. Elite's management will host a live conference call on Thursday, June 15^th at 2:00 PM EDT to discuss the company's financial and operating results and provide a general business update. Stockholder questions should be summited to the company in advance of the call.

Conference Call Information

Date:	June 15, 2017
Time:	2:00 PM EDT
Dial-in numbers:	1-800-346-7359 (domestic)
	1-973-528-0008 (international)
Conference number:	98840
Questions:	dianne@elitepharma.com  by 9:00 AM EDT on Thursday, June 15, 2017
Audio Replay:	http://ir.elitepharma.com/events_presentations

What The Hell Is It This Time?

Elite is in a interesting place.  Some claim to know what IS bound to happen next, but I do not.  Yes, if you listen to everything you read you're going to have a personal shakedown.  And so you seek what might be sitting upright just around the bend and you get this shit...

For sure if you read the IHUB boards it's easy to get bullied into being scared really quick. Like this comment from one guy:

Elite should make a new 52 week low once the real Sequest results come out... and they will but not through the efforts of the company. Not this time around!!

This time I have a little surprise prepared
Watch & learn

There should be another side, right? Of course - Oh wait, that same guy also added this, "The closer to Friday, the lower Elite seems to be going... wonder why?"

ELTP May 2017 Filings

ELTP News: Amended Current Report Filing (8-k/a)
ELTP News: Current Report Filing (8-k)
ELTP News: Statement of Changes in Beneficial Ownership (4)
ELTP News: Securities Registration Statement (simplified Form) (s-3)
ELTP News: Small Company Offering and Sale of Securities Without Registration (d)
 

ELTP needs movement

it's difficult to make a buck in the pharma industry these days.  the internet has turned the stock market into a deadly vicious uncaring death pool waiting for you to be tempted to take a dip.  elite pharmaceuticals has been disappointing during the last 12 months, but it is not for apparent bad leadership.  obviously, Hakim made forecasts and did it in a bold, confident manner.  the FDA made him eat his words but thankfully Hakim stays positive without letting delays and rejection skew his path.  but it is so quiet lately, and the movement on the share price has been disappointing despite progress with the pipeline. 

here is a sample of posts from the day:

from: Inthe203  

HERE IS ONE ISSUE WITH THIS DRUG

CLINICAL TRIAL ISSUE:

With a fatty diet and the consumption of one pill, the patient had the sense that the drug wasn't 'kicking in' or effectively working. The patient will then take ANOTHER ONE or even a THIRD and still not receive the maximum effect of that first pill taken. IN THE MEANTIME, now three pills are consumed and the patient is now in jeopardy of an actual overdose without realizing it.

THIS IS WHY the FDA denied the approval.

THE FDA also clearly stated in their response that putting a WARNING LABEL on the bottle will NOT suffice, which poses a HUGE problem for ELTP.

There's no conceivable way around this issue. This is ONE of prominent loopholes ELTP is struggling with and unless the company is physically present to tell the consumer to watch their eating habits, this simply isn't going to end well.

As an investor, i'm extremely disappointed. I'm guilty of putting all my eggs in one basket (just shy of 7M shares) and i'm stuck holding the bag.

I'm looking for a miracle and NO ONE can challenge me on this. I'm simply telling you factual information that came out of the mouth of the FDA!

$ELTP$ 

by:  WeeZuhl

40,000 ER docs in the U.S. with at least as many NP/PA's working in the ED, probably a lot more. Approx 80,000 E.R. providers.

Now add in Urgent Care. 10,000 urgent care clinics in the U.S. Each clinic probably has an average four docs and as many NP/PA's, so we'll approximate another 80,000 urgent care providers.

Approximately 160,000 E.R. and urgent care providers in the U.S.. We convince just 10% to switch to SequestOx, and they write an average of one script per shift- about 20 scripts in a month of 20 pills each.

160,000 x 10% = 16,000

16,000 x 20 scripts x 20 pills x 12 months = 76,800,000 capsules per year.

Now set your price. Say $5/capsule (approx. 5x of generic oxy capsules).

76,800,000 capsules x $5/cap = $384,000,000 / year in revenue just from 10% of ER and urgent care providers writing 1 SequestOx #20 script per shift.

Now what happens if you get buy-in from 25% of the those providers? 50%? Now start to add in pain management, primary care, and orthopedics. 

by: aELmTPa  

The modified formula is already complete and trials have started comparing the new formula to the old one.

Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.

the modified formulation

the modified formulation

the modified formulation

 

Elite Pharma Release; Company Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic Oxycontin

NORTHVALE, N.J, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016. The topline results indicate that Elite’s generic product is bioequivalent to the branded product, OxyContin® (extended release Oxycodone Hydrochloride). A fasted study was previously conducted in September 2016, also with positive results.

The study was a single dose crossover comparative bioavailability study of Oxycodone HCl extended release in healthy volunteers under fed conditions. The Elite product is a generic formulation of the branded product, OxyContin®, with strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, and incorporates physical abuse deterrent properties. IMS reported approximately $2.5 billion in revenue for OxyContin in 2015.

“Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx™, I am now very pleased to announce these positive topline study results for an abuse-deterrent twice-daily Oxycodone,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We intend to file an ANDA for this product later this year.”

A new way to pharma

ELTP chugs along and if you've followed along in the message boards, my deepest and most sincere condolences.  Best to let your investment breath, which also isn't to say not to demand the best from the CEO.  You're weak if ya do and weak if ya don't so worry not.  Elite has a ton going for it, they just are not the PR machine it used to be so wait for it.  When stupid fucktards make comments like "Why did it take 6 months to address the CRL I mean with expedited review it should have only take 3 months. What was Elite doing all that time?" you don't need to take time out of your day to respond, there is no need to educate, the fucktards are going to be fucktards when you let em.  I find the message boards, particularly on iHub, to have lost serious luster and when you just have a bunch of folks pushing against something that may or may not - at the end of the day facts good or bad will surface with out the hyperbole.  In a perfect world that is.. 

PR like the following don't say much of anything, so what.  If you can't draw as much based upon a first glance over of the PR maybe you need to be sucker punched anyway!

Elite Provides Update On SequestOx™ New Drug Application
NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the Company met with the U.S. Food and Drug Administration (the "FDA") on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx™. Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter ("CRL"). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.

SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride) is Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The proposed plan submitted by the Company addresses items cited in the CRL dated July 14, 2016 for the New Drug Application (the "NDA") for SequestOx™.

"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."


So you see, no need for gratuitous expletives, ad hominem attacks, or other displays of internet weakness.  Push for the best, demand the best from your CEO, work together in the boards for a better day by using the facts, yes especially those hard to swallow facts.  Those come in handy and then find your trends or just sit back and show confidence in where your money is sitting.

FDA and Elite have agreed to a clear path forward for SequestOx

<EOM>