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Sorry, Rizzo, this belongs on the Nostrum page. Nasrat sold Elite's methadone ANDA to his buddies at Nostrum Pharma for pennies on the dollar. How does it make it you feel that he dumped this drug that is used TREAT opioid abuse and has been manufactured by Elite since 2010 without any negative legal ramifications?
Bonus points if anyone can explain why he committed this destructive act against Elite.
What the hell are you talking about? What destruction? What happened to which tiny companies? Generic opioids are still a mainstay of modern medical treatment, and nothing happened to the manufacturers who have been operating responsibly. And why was the flagship product shelved? Because Nasrat decided after spending $50 million on it that it wasn't worth submitting the final application. These were not unforeseeable acts from God. These were deliberate acts from Nasrat. If he saved us from anything, it was his own destructive decision-making.
It's like the captain of Costa Concordia, who said he deserved credit for running aground so close to shore. He said many passengers were saved because of what he did. Yeah, but...
I read there are currently more than 120 COVID-19 vaccines in development, and the only way to tell if they provide lasting immunity is try them out. That's why it typically takes 4-5 years to develop and test a vaccine. Probably every one of the 120 has an argument for why they are building the better mousetrap.
Moderna's whole existence is based on rapid development of vaccines for emerging diseases. Their vaccine is a package of mRNA delivered in a lipid envelope. mRNA is the actual working-copy of a gene that cellular machinery uses to make peptides, which are folded together to make new proteins and enzymes. Moderna sneaks in a bunch of mRNA that encodes portions of the viral spike protein, so now the cells start manufacturing fake spike protein peptides. Moderna has proven that the human immune system recognizes these fake spike peptides as foreign and then develops an antibody response. They have not yet proven their vaccine provides immunity to COVID, either transient or long-term. They have not proven long-term safety.
Antigen Express utilizes a peptide vaccine. They used computer modeling to predict which portions of the spike protein are most likely to trigger a strong human immune response (EpiVax collaboration), and then they joined the computer-generated fake spike peptide with their proprietary Ii-key peptide. The addition of the Ii-key peptide is what makes our vaccine unique from any other. The Ii-key peptide is like a silver platter for the fake spike peptide. It draws the attention of specialized immune cells, called helper t cells. If I were a t cell, I would want to be a helper t cell. They tell all the other immune cells what to do. Killer t cells act tough, but helper t cells run the show. Ii-key peptide activates helper t cells, and theoretically, results in a stronger vaccine response. That's our whole bet.
Odds are that the first vaccine to finish Phase 3 will not be the best vaccine. You don't have to be the first to be the best, but you do have to be on the same lap.
I think the only new info here is the identity of the unapproved ANDA. When I first looked at it, I saw acetaminophen and caffeine and immediately thought it was Fioricet, which is a semi-popular headache med that also contains butalbital. But this drug is not Fioricet. It has dihydrocodeine instead of butalbital, which means this is Panlor. LOL. All I can say is that I sort of remember reading about Panlor in med school Pharmacology. Since then, not so much.
Why amend a seven year old 8k on a Friday afternoon? No idea. Seems like somebody is getting their ducks in a row for some reason.
In the New Era of Shamelessness, the company now feels comfortable revealing in one complete list what the shareholders received from Nasrat for our $10 million. As it turns out, 5 of 13 ANDA's were for various forms of phentermine. (Ever heard of fen-phen?) The pending ANDA for Fioricet was apparently never approved. Nothing on the whole list worth more than a few hundred thousand dollars, most of them a fraction of that.
This is like going to Yale for your degree in Education. The economics were probably never going to work out favorably, but that doesn't mean you should drop out 3 weeks before graduation just because Uber drivers make a ton of money.
The number of ANDA's allowed in our current category is 19. The number of currently-active ANDA's listed for Elite in the FDA Orange Book is 13. I will allow my gentle readers to determine for themselves the veracity of the claim that our opioids had to be sold off in order to avoid higher fees.
Almost like real money. Where would we be today if we had our own approved NDA for SequestOx AND our line of generic opioids in tact AND the CNS stimulants? Besides a tidy bit more income, this would also be a more diverse portfolio. I guess it's like they say, we just can't have nice things around here.
Please clarify. For what illegal behavior would Elite be sued? Why didn't we get sued already, since we've been selling hydromorphone and methadone since 2010/2012. Since you support the selling of the opioid ANDA, do you think Nasrat should ask Epic to stop sending us our 15% share of oxyIR?
Well, there's the rub. With LPC II, the only thing that ever stopped the pressure was when the share price permanently dropped under the minimum price of 10 cents. With LPC III, the minimum price is 3 cents.
I should be more clear. This doesn't mean that Nasrat has put any shares to market yet under LPC III. This downward grind could be just the 6 million "Commitment Shares" making their way to market. According to the paragraph below, Additional Commitment Shares are owed for each transaction.
First, LPC gets millions of shares just to enter the agreement. When Nasrat needs money for whatever he informs LPC of how many shares he wants them to buy. There are limits, as per the agreement, as to how many shares and how frequently he can do it. I don't know the above details of LPC III off the top of my head.
The purchase price is calculated such that LPC gets a discount on every share, and they immediately/quickly sell those shares on the open market. They are not long term investors, they are the mechanism that Nasrat uses to turn shares into cash.
We hadn't seen much LPC dilution because LPC II had a 10 cent floor. Once Nasrat caused the share price to permanently drop below 10, he could no longer sell shares to LPC. He took care of that problem in LPC III with a 3 cent floor, which means that Nasrat can keep putting shares to market until the share price is below 3 cents.
LPC makes money no matter what happens to Elite. Nasrat is making money off the Adderall ANDA's. Elite shares will likely be in the 5 cent range this week or next. And, yes, you are correct, LPC III is definitely causing the share price to push down to historic lows.
Elite shareholders are probably not legally-entitled to this information. I'm not a lawyer, so I don't know. Thanks for the links, but I didn't see any mention of our particular situation, where the sole owner of a private company is also CEO of a publicly-traded company, and the two companies do business with each other. Add another layer of concern when the private company starts making secret side deals with a major partner of the public company, including taking over assets of vital importance to the public company. I don't need a link to dummies.com to tell me that is a highly irregular situation. In fact, some might say it has the APPEARANCE OF IMPROPRIETY.
I didn't look for an Investopedia link to support this, but I think as a general rule, publicly-traded companies try to avoid having their CEO involved in highly-irregular situations with the APPEARANCE OF IMPROPRIETY. Also, (again no Investopedia link) I think investment funds tend to shy away from companies who have a CEO doing irregular business deals with the APPEARANCE OF IMPROPRIETY.
My goal is not to convince two private companies to give up information. My goal is to convince the Elite Board of Directors to perform their fiduciary duty to ALL Elite shareholders, not just the biggest shareholder. Let's see what Investopedia says about that...
Nobody wants Tylenol #3 because nobody wants codeine. It is a weak analgesic with a limited therapeutic window. It requires higher doses for effective analgesia, but it has the typical opioid side effects (i.e. nausea, lethargy) at those doses. In 2017, FDA restricted codeine use in kids (which was a full 18 months before Elite filed the ANDA). Oxycodone, hydrocodone, and hydromorphone are much stronger, and therefore they are much more effective at lower doses, which means the side effects are much less. Methadone tends to have more side effects, but it has the benefit of a longer half-life and is longer lasting.
It was a waste of money to develop, and that is why nobody wants to waste their money to buy it. Please don't confuse Nasrat's stupid decision to develop codeine with some rational explanation for the Great Opioid Massacre of 2019. And also, don't mistake Nasrat's smart-alecky disdain for Elite shareholders as one of his positive attributes.
As for whether or not opioids are over-prescribed, yes, for sure, but not as much lately as in the past. For chronic pain, I tend to have better luck over the long term with some old non-narcotic favorites, like escitalopram and bupropion, and new friends, like pregabalin. But there is a role for opioids for acute and breakthrough pain, and I refuse to leave my patients to suffer when there is something I can do about it. I've said it before on this board, in regards to lumbar spinal stenosis, I've made people walk again with a fentanyl patch. Very low side effective profile, very effective drug. Should I leave those people in pain in their wheelchairs because I have a moral objection to fentanyl? Not me.
Actually, I have not been calling to get rid of Nasrat. For God's sake, I haven't even called for getting rid of Mikah! And it's not just history. Our opioid ANDA's could have contributed $50M last year. And this year. And next year. And every year after that. Maybe more. It matters what he did, and it will continue to matter every year going forward.
I realize that it must be frustrating that no one has managed to factually contradict anything I've posted. I'm sure it must be very disappointing that so few have even tried. The silence is deafening. It seems like we are down to half a handful of investors who continue worship Nasrat.
Sorry, how could I forget the Epic development agreement? FAIL. This was where we gave Nasrat $10M for his 13 generics, and then Epic proceeded to sit on 11 of them for next however many years. And don't forget, Nasrat is a member Epic Investments, according to Dianne. He has received ELTP share distributions from Epic.
Possibly the DUMBEST business decision in the history generic drugs. The companies who were sued were either doing illegal marketing or they were sending millions of tablets to tiny rural counties. Literally, egregious, illegal behavior in a Wild West industry. For one thing, Elite doesn't advertise any of their drugs, so kind of hard to get sued for that. People seem to forget that we were selling hydromorphone since 2010, and methadone since 2012, and oxyIR since ~2015. Did we get sued? Of course not. And the opioid industry is so highly regulated now that every single tablet is accounted for from warehouse to pharmacy to prescriber to patient. It is impossible to do today what those companies did in the 1990's that caused them to be sued.
I hope Elite shareholders will take a minute to read about the opioid lawsuits. The idea that it was a legal risk to our company to sell legal products in a regulated industry is so ludicrous that it is impossible to comprehend. Selling those ANDA's for a fraction of their cost to develop was so unwarranted as to have the APPEARANCE OF IMPROPRIETY.
$160 million might make it move, but we're a very long way from that. We have both Adderalls on market for several quarters and Nasrat is talking about a $7 million q. You'd have to triple that just to get halfway there. Remember, we don't know the deal with SunGen, so we don't know how many millions of dollars is ending up in Nasrat's personal bank account. It looks like a loooooooooooooong time before we see $160M from Adderall, and it looks like an even longer time before we see a hint of the Concerta filing.
You're already there, elichen. Spine up is Step One in expecting better from Elite management. It means it is time to stop apologizing for Nasrat's repeated failures.
He was appointed on 8/5/13, and share price was .07 with 395,000,000 shares outstanding. After 7 years, share price is lower and outstanding shares are over 1 billion. Every single development project has been a failure, and even the successes were turned into failures. Spine up means stop treating him like a messiah and start recognizing his failed leadership.
Nasrat Hakim's tenure as CEO of Elite has been nothing but a giant FAIL. Any Elite shareholder who thinks he's doing anything but the WORST job ever needs to spine up.
And remember, the only reason Elite doesn't already own 100% of the Adderall ANDA's is because Nasrat literally wasted 650,000,000 shares on NOTHING but FAIL. The idea that Nasrat Hakim and Mikah are enriching themselves by siphoning millions of dollars from Elite, while the share price is at historic lows, is disgusting, and any Elite shareholder who isn't sickened by the thought of it needs to spine up!
Jour, with your knowledge of publicly traded companies, can you think of other examples of CEO's who maintain a second private company for the purpose of doing business with the primary company? IMO, this is highly irregular, and under normal circumstances, neither the BOD nor the general counsel/regulatory officer would allow something like that to happen. Since 2013, Elite shareholders have had to accept multiple dubious deals with Mikah without any way to make a true assessment of the quality of the deals because of the private, secretive nature of Mikah. Trimipramine is a perfect example. The ANDA was purchased by Mikah to shield Elite shareholders from the purchase price, then it was sold to Elite two weeks later at a substantially-inflated price. The original 13 ANDA's for $10M is the exact same. Just how obnoxiously-inflated the cost was is impossible to know- because Mikah. What BOD would stand for this? Now its happening again with Adderall.
It's time to expect better from Elite management. And, frankly, it's time to expect better from Elite shareholders, too. Spine up.
We were going to get into this next week, but as usual, NASDAQ pushes the envelope. Let's discuss.
Nasrat says he hopes Elite gets full ownership of the Adderall ANDA's, and I believe him. In terms of a buyout, Nasrat would want 100% of Adderall $$ recorded as Elite revenue, which then would enjoy the magical multiplication benefits of the PE ratio. But here's the wrinkle- he can do it at the last minute and still get the full benefit. I guarantee when Nasrat does get around to letting Elite have that revenue, it will be a split second before the start of a fiscal year. Until then, it is to Nasrat's benefit to let his baby MIKAH continue to suckle at the Adderall teet. MIKAH grows fat and strong, helping out Elite whenever possible with a discarded ANDA at "friend" prices, on credit. Meanwhile, Elite continues to languish without enough revenue to support even a dime of share price, for years on end. Shareholder dilution continues to support limited R&D budgets. Concerta delayed for 1 year, 2 years, 3... Elite stays weak and gimpy until Nasrat says otherwise.
Why should Nasrat get to personally benefit from Adderall while Elite shareholders sit in a ditch hoping for scraps? I can understand why Nasrat hates me, but why does Nasrat hate NASDAQ?
If you don't care about the share price, then stop reading. If you do care about SP, then we need all the income we can get. It's too late to save the opioid ANDA's from Nasrat's deranged pruning spree, but it's not too late to save the Adderalls. The sooner the better. I'm going to try to do something about it. In the end, I may be powerless to affect real change, but that doesn't mean I shouldn't try. I'll at least know I stood up for myself. It's time to expect better from Elite management.
It seems like a lot of money for an old ANDA, but the salesman said it was barely used and had been kept in a garage and only driven to church on Sundays by a little old lady from Poughkeepsie.
IB, I'm no kind of specialist in business strategy, so it may be that I haven't had the correct Risk Analysis seminar yet. Maybe someone with that training could help me understand.
Elite 2019 1. Trace money in bank. 2. Trace income. 3. No access to capital. 4. Historic low share price. 5. Going concern. 6. $20M burn rate. 7. Discontinued 5 opioid ANDA's worth up to $50M/yr due to concern of being sued for legal behavior in a highly-regulated industry. 8. Sold off 4 opioid ANDAs for a fraction of the cost to develop them.
For me, the decisions that Nasrat made about opioids are ludicrous. The whole scenario is so bizarre that it has the APPEARANCE OF IMPROPRIETY, especially considering the secretive private pharma that was supposedly shut down years ago.
Nasrat says: I had to dump the opioids before I started acting so illegally and egregiously that the company is sued. I just couldn't be trusted to commercialize and sell opioids like the majority of manufacturers who haven't been sued. The private deals I am making with my other secret company are completely unrelated.
I don't think they've had them long enough to commercialize yet, especially since they didn't do any of the bioequivalence tests or other proofing studies. We did all that, the shareholders, through dilution. But if you like the feeling of a gut-punch, feel free to look up our Norco and Percocet ANDA's in the FDA Orange Book, now listed under Nostrum ownership.
What would Percocet and Norco have done last year? 100% Elite owned. $20M? $30M? $50M?
What was the R&D for Percocet, Norco, methadone, Tylenol #3? (All filed in 2016 or after.) $10M? 20M? How many shares was that? 150M? 250M?
And, again, if anyone can make me understand why we bashed in the skulls of our geese that lay the golden eggs, I still don't get it. Expensive friggin geese.
Thanks for reading, and thanks for asking. I will see how I do and then make further decisions about my position. Here are my goals:
1. Ongoing oversight with an independent auditor for both Elite & Mikah who will guarantee that material events for Mikah are reported to Elite shareholders.
2. Establish the details of the Adderall Purchase Agreement between Mikah and SunGen, including and especially any partners or financing involved.
3. Establish a protocol for the transfer of the Adderall ANDA's from Mikah to Elite and immediately begin the protocol.
It is time to expect better from Elite management. Stay tuned, more to come...
Dianne's job is to insulate them from you. She is powerless to do anything other than give you the run around. I have no intention of involving Dianne in anything I will be doing to try to establish real corporate oversight at Elite. It is time to expect better from Elite management, including the officers and board members (but not Dianne).
A little research will prove that Hanlon's Razor appeared on my footnote before it appeared in your recent post. I look forward to when you have an opportunity to address any of the issues that I am raising.
And this is the one I was aiming for:
adjective: gross 4. general or large-scale; not fine or detailed. "at the gross anatomical level"
It started on day #1 with a 10 million promissory note for 13 low-volume generics, and it never stopped. Extravagant interest rates, free warrants for share conversions, lots of secret, self-dealing with Mikah. It continues to this day, including the corporate theft of our extremely valuable assets in the form of opioid ANDAS. Now he is using control of Adderall ANDAS to once again fleece the shareholders and extract even more personal wealth from the company.
Nasrat is the reason this stock will not increase in price. Does everyone remember how volatile this stock used to be? It was actually fun to own and watch, but now it's just a bloated pig slowly sinking lower in the mud. 500 million shares wasted on half-baked ADF efforts and opioid ANDAS, without a penny of income to show for it. It is not a mystery why the PPS no longer does anything but grind down. Nasrat's shiny new LPC dilution machine (with a 3 cent floor!!) will not help this.
It is no longer possible to believe that if Nasrat does well then I will do well. The failure of this company is not entirely due to Nasrat's miserable leadership skills. It is also the result of his unethical extraction of personal wealth for himself and his pharma bros through constant self-dealing with Mikah. It is time to expect better from Elite management, and that includes all the company officers and board members. They all have an obligation to prevent malfeasance, and it is time for them to wake up.
Since nothing in the entire dissertation addresses anything I've said over the past 2 days, I'm not sure what this Q&A is meant to address (or when). It's not any of the points I've brought up. (Shareholder Rights Agreement of 2013?? Really????) But please, don't hesitate to eventually address some of this stuff. There is still plenty more to talk about, and such a milquetoast response was a real disappointment, tbh. A more spirited discussion would be helpful for all.
Now let's work and try to recover something instructive from this gross verbosity. Ah, yes, here's something:
ELTP BOARD POLL QUESTION Annual revenue in FY2020 was 18M, but what should it have been?
Reply with your response. What if Nasrat had commercialized each of the opioid ANDA's as they were approved? What if all 5 opioids had full year sales?
Buddy Berk!!! As far as I can tell, Buddy Berk is no longer President of Nostrum, but it seems like he was at the time our opioids were stolen. He does seem to still be on board of Nostrum affiliate inspirX.
I apologize. Farbeit from me to suggest Elite shareholders were not fairly and equitably treated by Nostrum Pharma. I am sure the highest level of ethical deliberation was applied to the transaction.
I still can't believe they're gone. Poof. After years of development and millions of dollars-- sold for pennies without any discussion. I make business and personal decisions the same way I make medical decisions. Step One is to analyze the risks & benefits. What was a bigger risk for our company? Our auditor called us a going concern because of lack of income and lack of access to capital. Our low, low share price makes our current capital access through LPC extremely dilutive. Elite shareholders have already seen their positions diluted by 2X. This company was and is desperate for any source of income, and Nasrat refuses to commercialise these highly-lucrative assets. And then he dumps them out the back door so his NJ pharma bro can come by and load them up.
After everything Elite has gone through at his direction, Nasrat decided the bigger risk for our company was being sued for perfectly legal behavior in a highly-regulated business. Who can help me understand this? For me, I can only see the APPEARANCE OF IMPROPRIETY.
I'd be very interested to hear from any investors who think this sounds legit. If this seems like an above-board, arm's length, righteous business deal, then please reply with further explanation. For me, I can only see the APPEARANCE OF IMPROPRIETY.
Elite paid Mikah $1.2M for trimipramine, a 60-year-old tricyclic anti-depressant with annual sales ~$2M. Like all TCA's, trimipramine is on the Beer's List due to anticholinergic effects. I hadn't heard of it since medical school, and I've certainly never prescribed it. I can't imagine any circumstance in which I, as a PCP and board-certified internist, would ever write for a single dose of trimipramine for anyone. On the other hand, over the course of my career, I've written literally 1000's of prescriptions for IR generic opioids. They are a mainstay of modern medical treatment. So how'd we do?
Huh. 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. It begs the question: is there a business relationship between Nostrum and Mikah? What about with Epic Investments?
This is an example of how Nasrat does himself and shareholders a disservice by withholding information that could easily overcome the APPEARANCE OF IMPROPRIETY. It is time to demand better from Elite management.
That's the question, isn't it? I have some ideas, but we need to work together to develop specific goals. We need to express ourselves in ways that will affect REAL change. We need to make Elite management understand that we're here to stay and this problem will not "just disappear."