Dissolution of Mikah is not up to Elite shareholders and neither is ownership of the assets, now and previously owned by Mikah.

What's Nasrat's incentive for getting MIKAHs half of Adderall sales to Elite.
Having half of Adderall sales (MIKAH) is a comfortable income without ever getting rid of Elite.

10K-2016: Mikah has accordingly ceased operating and is in the process of winding down and liquidating its assets.

In May 2017, through Elite Labs, we acquired from Mikah Pharma an FDA approved ANDA for Trimipramine for aggregate consideration of $1,200,000.

secretive private pharma that was supposedly shut down years ago

Subsequent to the execution of the Mikah Development Agreement, and before any development milestones were achieved, the sole owner of Mikah, Mr. Nasrat Hakim, became the President and Chief Executive Officer of the Company. Mikah has accordingly ceased operating and is in the process of winding down and liquidating its assets.

Could it be that "HE" actually received MORE than what was reported ????????

i wonder how much $$$ the drugs thatNas sold for pennies have generated for the company that got them so cheap?!?!

Do you plan to reduce your position or will you still hold? (I suppose you will not increase your share count) Thanks!

Post to Dianne

OBTW: I see that a footnote reflects something I said before. Perfect irony.

enough is enough of this historical crap...its over & done with...

Q1: What does the noise of today have to do with Elite’s future?
A1: Nothing. What follows is meant to help enlighten investors.

Q2: What was the improvement of revenues YOY?
A2: The move was from $7.5 M to $18 M.

NJ pharma bro

Bernard J. Berk
Mr. Berk is a Director of InspiRx and serves as President and Vice Chairman of Nostrum Laboratories, Inc., a subsidiary of NPLLC, the parent company of InspiRx. Mr. Berk has served in the generic pharmaceutical industry beginning with Par Pharmaceuticals, Inc., where he was Senior Vice President of Sales, Marketing and Business Development. Thereafter, Mr. Berk was, respectively, President and Chief Executive Officer of Nale Pharmaceutical Corporation (an Elan affiliate) and Chief Executive Officer and Chairman of publicly traded Elite Pharmaceuticals, Inc. Mr. Berk has also served as President and Chief Executive Officer of Michael Andrews Corporation, a pharmaceutical management consultant firm. Mr. Berk holds a B.S. from New York University.

Historical Milestones

For those who have been around for awhile (hi doc!), you may have already noted that we're approaching the ten year anniversary of Elite as a penny stock. The early years from 2000-2003 were tumultuous, mostly in a downward direction. Think Red Dragon where Dollarhyde lit the tabloid journalist on fire and sent him careening down the hill in a flaming wheelchair. Started at $14 with plans for 24 hour oxy and antagonist ADF. It hit the buck fifty range in a little over three years, by March 2003. That whole time period has been sent down the rabbit-hole and expunged from official history. No PR's exist in the elitepharma.com online archive dated prior to March 2003, and the first one is from the board saying the founder and CEO Mehta couldn't have quit because they had already fired him. The two sides settled for cash in exchange for the patents. When Mehta later sold out all his shares, it was around 1.3 million total, which is funny because I have a bunch more shares than the founder ever had. I'll have to check, but I think the authorized share count might have been a tad bit lower back then. Check out that earliest PR and you'll see somebody you recognize (hi Dianne!).

After Mehta came Buddy Berk. The share price remained volatile but overall bounced up and down off of a $2.00 base for years. Ten years ago this week on 11/29/07 it closed below 2 for the first time. Then it got ugly. For Elite in 2008, think Die Hard where Mclane throws Hans Gruber off the Nakatomi Plaza. January 2 was the last time it ever closed above $2, and just like that one month later it closed below $1 for the first time. March 26, 2008 was the last time it closed above one dollar, and as of that date in 2018, Elite will have been a been a penny stock for a full ten years. Buddy Berk got as far as getting a SPA from FDA for a Phase 3 study for ELI-216, what would have been the first ever oxycodone antagonist ADF, but by then the company was in no shape to do anything with it. September 19, 2008 it closed in single digits (.07), and by November 2008 Jerry Treppel was brought on to the board and Berk was out.

Acting CEO Chris Dick and Treppel et al saved the company from bankruptcy with the Epic Strategic Alliance in March 2009. For this, think of the beginning of Braveheart where Longshanks rides with a heavily armed unit of cavalry into the middle of a wedding party and eats all the food and takes away the virgin bride to invoke his nobleman's right of Prima Nocta. For less than $4 million, Epic's three members ended up with three seats on the board and enough Preferred shares and warrants to ultimately, effectively control the company.

Barely breathing, Elite was delisted from Amex in May 2009. Treppel was named CEO in November 2009, and he became like Travis Bickle in Taxi Driver, ensuring the survival of the tough but vulnerable young prostitute Iris, who every day does whatever is necessary to survive, no matter how low. Treppel moved the company toward generics, starting with methadone in 2009. The next year, Elite purchased the naltrexone ANDA from a company called Mikah Pharma. I'm sure with a funny-sounding name like that, we'll probably never hear anything more about them.

It's a miracle this company didn't go bankrupt in 2008 or 2009. But it didn't. It's like in Stranger Things, when Eleven uses her power to stop Mike in midair as he free-falls off the cliff and toward the bottom of the quarry. An Epic survival, literally, mainly on the back of Lodrane-24D, an illegal decongestant with enough stimulant to suck every secretion dry until your mucus membranes are fully-desiccated and you can't pee or poop right for a week.

I bought my first shares on May 10, 2011, 10,000 shares at 14 cents. Soon thereafter the FDA pulled Lodrane-24D, and I got my first taste of life as part owner of Elite Pharmaceuticals. Treppel transitioned the company from survival to growth, and handed the baton to Nasrat Hakim. It's hard to imagine everything that has happened since then. How far we've come but how little we have to show for it. But the antagonist ADF tech the company was originally based on was way before its time. Even now, with the opioid epidemic in full bloom, we still allow kids to snort non-ADF IR opioids like oxyIR, Norco, and Percocet. It never had a chance in the early 2000's, which was years before anybody ever heard of OxyContin, Hillbilly heroin, or pill mills. If ever there was a time to commercialize the original ADF tech, now is it. Elite has ready-to-go antagonist ADF versions of Norco and Percocet, and as always, the ADF oxyIR version should be ready to go soon. Maybe someday somebody will decide we ought not to let kids snort this crap. After all these years, Elite is ready for that day to be today.

so his NJ pharma bro can come by and load them up

Pharma chief defends 400% drug price rise as a ‘moral requirement’
Nostrum Laboratories’ Nirmal Mulye says he is right to charge as much as possible and slams FDA
David Crow in New York
SEPTEMBER 11 2018

A pharma executive has defended his decision to raise the price of an antibiotic mixture to more than $2,000 a bottle, arguing there was a “moral requirement to sell the product at the highest price”.

Last month, Nostrum Laboratories, a small Missouri-based drugmaker, more than quadrupled the price of a bottle of nitrofurantoin from $474.75 to $2,392, according to Elsevier’s Gold Standard drug database.

Nitrofurantoin is an antibiotic used to treat bladder infections that was first marketed in 1953, which appears on the World Health Organization’s list of essential medicines. It comes in a tablet form as well as a liquid version that Nostrum makes.

In an interview, Nirmal Mulye, Nostrum chief executive, said he had priced the product according to market dynamics, adding: “I think it is a moral requirement to make money when you can and to sell the product for the highest price.”

Nostrum paid Elite $1.2M for #4 IR opioids with annual sales worth hundreds of millions of dollars.

Elite paid Mikah $1.2M for #1 drug with two million dollar sales, and Nostrum paid Elite $1.2M for #4 IR opioids with annual sales worth hundreds of millions of dollars.

Elite paid Mikah $1.2M

Oxycodone and Acetaminophen 5mg/325mg, 7.5mg/325mg, 10mg/325mg tablets

The Approved ANDA for Oxycodone and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets was sold to Nostrum for cash consideration totaling $300,000 in November 2019.


Hydrocodone and Acetaminophen 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, 10mg/325mg tablets

The Approved ANDA for Hydrocodone and Acetaminophen 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets was sold to Nostrum for cash consideration totaling $300,000 in November 2019.


Hydromorphone 8mg tablets

The Approved ANDA for Hydromorphone 8mg tablets was sold to Nostrum for cash consideration totaling $300,000 in December 2019.


Methadone 5mg and 10mg tablets

The Approved ANDA for Methadone 5mg and 10mg tablets was sold to Nostrum Laboratories Inc. (“Nostrum”) for cash consideration totaling $300,000 in February 2020.

Exactly HOW do we “demand better” from Nas???

No specific sales numbers for trimipramine

Some of these recent business deals (and not so recent) by Elite and MIKAH have the APPEARANCE OF IMPROPRIETY.

SUPPLY AND DISTRIBUTION AGREEMENT

This SUPPLY AND DISTRIBUTION AGREEMENT (the “Agreement”), dated May 4, 2017 (the “Effective Date”), is by and between Dr. Reddy’s Laboratories Inc., organized and existing under the laws of New Jersey having an office at 107 College Road East, Princeton, New Jersey 08540 ("DRL") and Mikah Pharma, LLC, organized and existing under the laws of the State of Delaware, having an office at 20 Kilmer Drive, Hillsborough, New Jersey 08844 (“Mikah”). DRL and Mikah are each a “Party” and together constitute the “Parties” under this Agreement.

RECITALS

WHEREAS, Mikah owns a certain abbreviated new drug application (“ANDA”) for Product that Actavis LLC has the exclusive rights to market and sell. Due to a potential merger between Actavis LLC (“Actavis”) and Teva Pharmaceutical Industries Ltd., Actavis wishes to terminate the agreement with Mikah under the terms outlined in Attachment 1;

WHEREAS, DRL possesses expertise relating to the marketing, distribution and sale of pharmaceutical products; and

WHEREAS, Mikah and DRL wish to enter into an agreement whereby DRL will have exclusive marketing, distribution and sales rights to Product.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the sufficiency and satisfaction of which are hereby acknowledged, DRL and Mikah hereby agree as follows:

EXHIBIT A



PRODUCT INFORMATION



Product Batch Size Price Per Bottle without API
Trimipramine 25mg, 30ct bottle {***} See Product pricing given in Attachment 2
Trimipramine 50mg, 30ct bottle {***} See Product pricing given in Attachment 2
Trimipramine 100mg, 30ct bottle {***} See Product pricing given in Attachment 2

Attachment 1

Termination of the Asset Purchase Agreement and Master Supply Agreement dated as of May 25, 2016 by and between Actavis LLC and Mikah Pharma LLC

CONFIDENTIAL

Merged being subject to interpretation: like playing two hands at the blackjack table...

Separate hands but same decision maker.....

expected time frame for somewhere north of $0.30

Sure sounds like it was said...

So I take it you don't have proof of the CEO publicly spreading information he knew to be false about Sequestox; also proof of Elite not owning 50% of ER/IR?

Well, I'd say I'm not sure I would continue to hold such amount of shares if I felt the CEO publicly lied (Key word lied, not that he was severely mistaken) to investors multiple times about our alleged blockbuster product. But that's just me. I'd probably look at taking action.

So I take it the tranche of shares for sale at $3 is no longer in play now?

Boy, have you changed your tune. Need more cheap shares?

some baloney mixed in there.

Collegium had no problem with Xtampza...(an ER)..didn't seem to be a long and difficult path for them....it was the hair brained 2 bead tech that stopped Elite in its tracks

any thoughts on why Hakimus didn't pursue the ER first instead of the IR..that would have validated the two bead..no Tmax issue....but I've been asking that question for years even though i knew the answer.

it’s the fatty meal issue not anything about bioequivalence, so far as i know.

WeeZuhl, i always appreciate your insights. What i was referring to about the FDA was that they told Nas that the amount of time until the drug kicks in (i forget the official name for this) on the original version of SequestOx was a labelling matter—ie that it could be taken care of adequately by simply stating on the label of the bottle to take the pill either one hour before eating or two hours after eating a fatty meal—SAME AS MANY OTHER DRUGS—but then when we were ready to roll, they changed their requirement, would not allow simple labeling and crashed our opportunity to launch the product, sending us back to the drawing board for another few years and millions of dollars.

Exactly what would you have had him do differently? put differently, given the identical circumstances with FDA,
if you had been head of the company all this time, what would your strategy have been? What would you have done differently?

Did you ever see the results of Nasrat's hard work "over the next six to twelve months" from July 7, 2017?

I didn't.

Sep 20, 2017
Elite Pharmaceuticals Files ANDA For Oxycodone Hydrochloride Extended Release
NORTHVALE, N.J., Sept. 20, 2017 (GLOBE NEWSWIRE) --

...

"I am very pleased with this filing of an ANDA for a generic version of OxyContin®. This is our fourth ANDA filing in the past 15 months and is a key addition to our portfolio," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent pain products and attractive niche generics."

Aug 06, 2018
Elite Pharmaceuticals Receives FDA Approval For Generic Methadone Hydrochloride Tablets
NORTHVALE, N.J., Aug. 06, 2018 (GLOBE NEWSWIRE) --

...

"I am pleased to receive FDA approval for our methadone ANDA filing. We expect methadone to be a key product for our marketing alliance with Glenmark Pharmaceuticals," stated Nasrat Hakim, President and CEO of Elite.

100% of shareholders agree.

Quote:
Sheesh. Time for Nasrat to go far away.

Jul 07, 2017
Elite Pharmaceuticals Reports Topline Results From A Pivotal Fed Bioequivalence Study For SequestOx™
NORTHVALE, N.J., July 07, 2017 (GLOBE NEWSWIRE) --
...

"We were hoping for better and more decisive results for the reformulated immediate release version of SequestOxTM", said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "We remain positive with respect to Elite's abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months."

The blood screening program, which is scheduled to begin next week, incorporates T Cell Assays, antibody screening and isolation, virus neutralization tests (PRNT – Plaque Reduction Neutralization Test), and a novel in-vitro “cytokine storm” cellular assay. Through this proprietary method, Generex can identify the Ii-Key-SARS-CoV-2 peptides vaccines most likely to stimulate the appropriate T-Cell (CD4 and CD8) responses and modulate the correct immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response, with the goal of providing a broad-spectrum coverage for the vast majority of people. This strategy leverages Ii-Key technology to develop a “Complete Vaccine” that has the potential to induce the likelihood of protective immunity with long-lasting immunologic memory against SARS-COV-2 in a highly specific manner to ensure safety.

This is what is important for now. The arbitrator will figure out the rest:
Generex may issue, transfer or otherwise dispose of any shares of stock without any restrictions by the Court.

the manufacture is listed as Teva/Epic.

I think it is important to remember that a generic substitute can be approved by the FDA if it is between 75-125% bioequivalent with brand name product. The hour by hour pharmacokinetics will look different. Each individual will react differently to different formulations. I see a lot of comments about additives and such, but the real reason people prefer one manufacturer over another is because of the differences in the pharmacokinetic curves of the active ingredient. It is unlikely additives have anything to do with it. It stands to reason that any person who has been taking a particular product for a long time, especially a strong drug like Adderall, will notice the difference when they suddenly have to change to a different formula. If they are getting more active ingredient sooner, they will feel the symptoms of overdose (anxiety, palpitations, etc). If they are getting less active ingredient or getting it later, they might feel the symptoms of withdrawal (lethargy, headache, etc.). Some folks are exquisitely sensitive to changes like this, some will barely notice. Some folks will like the change, some folks will not. I don't think it means one is better than the other, it just indicates they are different.

When a pharmacy customer complains about getting a new generic drug from different manufacturer, they are really complaining about the CHANGE rather than the manufacturer. What is most beneficial to the patient is to keep it consistent from fill to fill. Even the people who complain about the new formula will adjust to it and do fine as long as they continue to get the same formula each time. Pharmacists and pharmacy buyers know this, and they know they will get more complaints if they have to substitute a new manufacturer because the usual product is not available (no matter how good/not good the substitute might be). It really is a problem and is unfair to the patient if they are forced to accept a different manufacturer with each fill. Most patients are restricted by their insurance and cannot shop pharmacies for the drug they want, so they complain bitterly to the pharmacist and online whenever it happens, especially if it happens routinely. These are the kinds of considerations that cause the Walgeens buyer to choose Lannett over TEVA. It is a huge opportunity for Elite, but it is also a tryout. Walgreens knows they will get more complaints initially, but what they want from their distributor is a consistent supply. If Elite and Lannett can supply a quality product without recurrent shortgages, then the buyer will continue to click the Lannett button.

Defendant’s ability to continue as an ongoing concern

The balance weighs against entering a temporary restraining order based on Defendant’s ability to continue as an ongoing concern due to the current COVID-19 pandemic.

Nice win for Generex. Just a skirmish, but a win is a win.

After reviewing the briefing and arguments raised in the Hearing, it is the Court’s determination that the balance of threatened injury weighs against the issuance of a temporary restraining order. The balance weighs against entering a temporary restraining order based on Defendant’s ability to continue as an ongoing concern due to the current COVID-19 pandemic. Some examples that July 14, 2020 10:35 AM 2 of 6 the Court relies on are that Defendant has seen a reduction in surgeries performed in VA hospitals which has affected Defendant’s current case flow, as well as the limited market for Generex shares as an over-the-counter stock.

...

As for irreparable harm, the Court notes there is potentially an argument that the Plaintiff could prevail with regard to irreparable harm, but the failure to meet the other elements of Rule 65A(e) prevents the Court from issuing a restraining order under these circumstances. The Court notes that this case presents serious issues on the merits which should be the subject of further litigation.

The expression "Pyrrhic victory" alludes to King Pyrrhus of ancient Greece. After King Pyrrhus's army suffered many casualties in defeating the Romans in battle, he reportedly said, "If we win another such battle against the Romans, we will be completely lost." A Pyrrhic victory occurs when the toll taken on the "winning" party does not offset the benefit of success.