Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
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."
Why does it matter? Mikah purchased trimipramine ANDA 077361 from Allergan in August 2016 as a part of a huge divestiture for Actavis merger. The price Mikah paid in August 2016 is unknown. Elite paid Mikah $1.2M just 8 months later through an undisclosed Promissory Note. How'd we do? Why wasn't Elite involved in the original deal? Why was a distribution agreement negotiated between Mikah and Dr. Reddy literally a few days before the sale to Elite?
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.
The signature page of the bill of sale for trimipramine @ $1.2M. Why doesn't Nasrat sign for both sides? The details of the Promissory Note are confidential. No specific sales numbers for trimipramine have ever been released, as far as I know.
Here is an SEC filing between MIKAH and Dr. Reddy. The details show that MIKAH's agreement with Actavis to distribute trimipramine ended in May 2016. Mikah and Dr. Reddy entered this exclusive rights agreement on May 4, 2017. MIKAH then sold the trimipramine ANDA to Elite two weeks later on May 22, 2017. As I recall, this was billed as a "favor" from Nasrat to Elite. The relationship between Elite and Dr. Reddy ended quickly and abruptly for unknown reasons. It certainly has the APPEARANCE OF IMPROPRIETY.
Nasrat is playing two hands at the same table, but deal after deal after deal the MIKAH hand wins and the Elite hand loses. It doesn't take long before the MIKAH pile of chips is overflowing off the table and the ELITE chips are completely spent. Sure it could be just dumb luck that MIKAH wins every hand and Elite loses every hand, but casino odds don't usually work that way. Some of these recent business deals (and not so recent) by Elite and MIKAH have the APPEARANCE OF IMPROPRIETY. As usual, Nasrat is doing himself and shareholders a major disservice by refusing to provide any details, and he alone is responsible for the APPEARANCE OF IMPROPRIETY.
It is time for this to stop. It is time for Elite shareholders to demand more and better from Nasrat on this issue. It is time to stop blindly believing every ounce of verbal diarrhea that comes out of his mouth like it is gospel. It is time to get active.
The only post that said anything about MIKAH owning 100% came from YOU. I'll be glad defend what I say, and I'll protect my words from people who try to change them into something else.
Revisionist history. Go back and prove it for yourself. The PR said it was bioequivalent, and it wasn't. You can find the link. I never said anything about Elite not owning 50%, so I refuse to allow you to frame this as part of my argument. You're the only one who said it, not me. Elite owns 50% and MIKAH owns 50%, and I never said MIKAH owns 100%.
I notice you're more concerned with my investment decisions than the things I posted today. This is your second reply about my investments and without addressing any of the important, factual points about the company. Do you have an opinion about anything besides me?
I currently own 2.5 million shares of ELTP, and as a long-term investor, I am happy to express & defend my opinions of Elite management whenever and however I chose. Any factual disagreement with anything I said?
I absolutely do not need any more cheap shares, nor do these shares require my assistance to be cheap. Brutal honesty is not a change in my tune, and I invite you to spend some time with my post history.
First of all, there is an obvious lack of understanding of how Xtampza got approved. It never should have been. It was still subject to patent infringement over the 12 hour oxy formula. One single judge bought Collegium's argument about the VENUE and dismissed the case. Before Purdue could re-file in the proper court, FDA took the opportunity to approve the drug. As far as I know, they've never done anything like that before or since. Why did they do it? Xtampza is just better in multiple ways, but it is much better to prevent chewing/oral dose dumping. They made a better product, and the FDA found a way. But legally it never should have been approved. Once it was approved, a judge refused to give an injunction to stop it, but it is possible that Collegium will still have to write a very large check to Purdue.
In other words, let's stop pretending that Xtampza's Stardust Approval was a typical event. By the normal rules, that drug would still be tied up in court.
This question has been answered REPEATEDLY. ER is MUCH more involved to prove safety and efficacy. IR= Quick & Easy, ER= Long & difficult. And which ER would he do? Oxy/Naltrexone ER was not possible because Pfizer's exclusivity. Morphine/Naltrexone ER was already a failure. I suggested several times that Dilaudid/Naltrexone ER would be a unique and interesting product, but that would have required substantially more time & money than Oxy IR.
The fatty meal issue and the bioequivalence issue are the exact same issue. Zombie SequestOx was never bioequivalent. As my previous research proved, the FDA never paid any attention to FED pharmacokinetics for ANDA (generic) oxycodone. Not a labeling issue but rather just didn't pay attention to it. But NDA's are different. Purdue had just gone down in flames at AdComm for their ADF oxy IR because of the exact same issue, lack of FED bioequivalence.
That is nonsense. First of all, I don't believe that bullcrap story and never have. Exquisite notes are taken during those FDA meetings ON BOTH SIDES, and those notes are exchanged so there is no confusion. If that were true, Nasrat would be able to easily release the notes of the meeting and prove his case, which he never has. I am not aware of these MANY OTHER DRUGS in which a lack of bioequivalence is handled with a labeling change. Can someone name a few? Name one? He failed to recognize an NDA app would not be treated with the same kid gloves as an ANDA app. The reason he didn't was because his head was up Camargo's butt while their hands were in both our pockets. I bet it was CAMARGO who spun him the tale about a labeling change, and NOT the FDA.
The brilliance of the SequestOx idea is that it would be a quick and easy way to get the 2 bead system on the market. It never was going to be a blockbuster, but it would have been a great flagship. When it ceased being quick and easy, it ceased being smart, but years later and after millions more, we were still blowing through shares pursuing it. Doubling and then tripling down on a bad bet. And we have literally NOTHING to show for it, except maybe Nasrat got a patent out of it, again at our expense. Meanwhile, through his own incompetence and stink of failure, Nasrat lets the share count go too high and share price fall too low, so that he gets his dilution machine taken away. When he finally does make a positive pivot to the CNS stimulants, he has to fund the R&D with sketchy Chinese government money. The only two worthy assets Nasrat has ever brought to Elite are Adderall and Adderall XR, and who owns them now? Mother-lovin' MIKAH. No kidding. Elite doesn't have a pot to piss in, other than 450M newly-authorized shares and a shiny, new dilution machine, but freakin' MIKAH owns the Adderalls. Didn't we already merge with that company in 2013?
Don't worry, all, Nasrat says he really hopes Elite is able to acquire the Adderall ANDAS some day. More on that to come....
What FDA circumstances are we referring to? What did the FDA do wrong? It was Nasrat who wasted millions of dollars and multiple years on Zombie SequestOx, despite knowing from the start it was not bioequivalent. (And despite what he told investors in a PR). FDA had nothing to do with the time & money wasted on the applesauce escapades. FDA did not screw up the reformulated bead, after another year and a few million dollars more. Nasrat did have a great idea of calling on an expert formulator to get the third attempt correct. Too bad he didn't have that idea 5 years and 500 million shares sooner. That bead now sits collecting dust, except for the lawyers fees going toward Nasrat's vanity patent application.
It was bad policy from the FDA that caused the demise of the 2-bead ADF versions of Norco and Percocet, but I gave Nasrat great credit for recovering those expenses by filing ANDA's for generic Norco and Percocet. We spent substantial sums getting those drugs approved, along with our own ANDA for methadone, and before we could recover any of our investment, they got sold off for pennies on the dollar, along with our generic Dilaudid. These bread & butter ANDA's would be adding very nice revenue right now. Not one responsible manufacturer of generic opioids has been sued by anyone. What bullshit.
Nasrat may yet lead this company to the promised land, but please spare me the infallible savior complex. Jeebus, Nasrat somehow even manages to turn our successes into failures. I bought shares last year for 6.5 cents, same price I paid 6 years ago, except back then there were only 340 million outstanding shares and now there are 840 million. Looks like I'll have the same opportunity this week. So "FDA circumstances" had nothing to do with Nasrat wasting 500 million shares from the treasury with ZERO shareholder value to show for it.
Separating the true scientists at Antigen from the true dufuses (dufi?) at Generex is overdue by at least five years. We can only hope the leaders at Antigen will have true independence from the perpetual penny-stockers at Generex.
This is 2 different manufacturers. If you look at your pills, do you have 2 different types of tablets in the bottle? IMO, this is the worst thing a pharmacy could do to you, especially if they didn't mention it. At the least, the pharmacist should have given you the option to do a partial fill now and come back in a week for the rest of the tablets from a consistent source. I would call and ask to speak to the pharmacist (NOT the pharm tech) about this.
"Going Concern" language appears to be in past tense.
From my initial reading, the auditor’s statement no longer contains an opinion expressing substantial doubt as to the company’s ability to continue as a going concern.
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. But if they can't...
Back in the Before Times when I was a young ER doc in the I-10 corridor, during the heyday of the OxyContin Express, drug-seekers would actually request that I write on the prescription "Blue Lor-tabs only." (Actually, the Southern pronunciation is "Lora-Tabs"). They didn't want the white ones. Sometimes we would do 48 hour shifts out in the boonies, and people would call ahead to see which doctor was on duty. The locals knew us all by name, but the I-10 brought us lots of players. It was a regular occurence that one patient would be discharged from the ER and five other people would get up and walk out of the waiting room. There is no sense in going through the bother of an ER visit if all they're going to get is 10 dang white Lora-Tabs.
I'm not sure that is true. Maybe a reason we have not yet seen the generic Concerta ANDA filing from Elite is because Lannett **IS** going to be our distributor? Lannett currently distributes generic Concerta through a "perpetual licensing agreement" with Andor pharmaceuticals. It is the only ANDA listed for Andor, which is listed as a foreign LLC. The details of the arrangement are confidential, but here's the flavor:
The only thing I know about "perpetual licensing agreements" is the undeniable fact that if my computer is working properly for more than 24 hours then Microsoft will immediately and automatically perform a mandatory Windows update that will screw it all to hell by the next morning. Maybe Lannett is tired of Andor's automatic updates, or the pharmaceutical equivalent. Maybe it is just not a good deal for Lannett. Whatever the deal is between Lannett & Andor, it seems to be structured over 4 years from the start of sales, which was some time in mid 2019. Lannett previously dumped Kremers version of generic Concerta because of bioequivalency problems, so they have proven they will make a big move for a better product.
Again, this is pure conjecture. I was hoping to see the Concerta ANDA filed before now. Thinking of possible causes of a delay, one obvious reason would be that Lannett's royalty deal with Andor is in place until mid-2023, three years away. Maybe the reason we haven't seen an application is because there is still plenty of time to get approval and be ready for launch with Lannett in 2023. Just a guess.
Damn. I thought I was about to get a new baby back secret. I'm more into bourbon than beer, but hell, I've got room in my life for all three- baby backs, bourbon, AND beer.
It will be easy enough to figure out in due time. Until then, I will reserve my baseless speculation. I agree that this change is precedent to an eventual buyout, but I disagree that it indicates anything about the timing of the buyout. It needed to be done, and it has been.
It's kind of like gin. You have to put down cards to pick up cards. With 13 listed ANDA, Nasrat has room in his hand for 6 more cards, to make 19. That's when things get interesting. And that's why I want to see more ANDA applications soon and soon again.
Because that's the way it was supposed to be. I don't know for sure why they did it like this, but the CNS stimulant ANDA's were always meant to be listed under Elite Labs. I'm glad to see it done, but it's just bookkeeping, IMO. It is interesting, though. Nice DD, Sharkey.
And technically speaking, after medical school, most doctors complete an internship and residency (hi UPMC!), so their level of thinking should be rated as "post-doctorate." Hey thanks a lot.
In regards to annual GDUFA fees, a medium-sized pharma has between 6-19 approved ANDA. I count 13 unique active ANDA listed in the FDA Orange Book for Elite Labs, and there are also 3 discontinued ANDA. The ANDA's cover the 11 drugs listed on the Elite website products page (link below). The reason there are 13 ANDA and only 11 drug products is because Elite has 4 active ANDA for phentermine but lists only 2 current phentermine products. (Interestingly, the 3 ANDA listed as discontinued are also for phentermine.)
No. Let's try again. TEVA's first ANDA for Adderall XR was never used and has been discontinued, but they acquired a second ANDA from Actavis. So TEVA still makes generic Adderall XR using the Actavis ANDA. They never stopped. Shire/Takeda has the original NDA, and they manufacture & market brand name Adderall XR. Prasco markets an authorized generic manufactured by Shire/Takeda under the NDA.