We look forward to talking to you again about more success in June when we filed the 10-K. Let’s go through Q&A. As I said before, Carter handled all the financial questions and there were a lot of them and many of them came in late last night or early this morning. I will be addressing the nonfinancial parts with a couple of comments in gengralities about financials. First question is on drug development pipeline. We know SequestOx was shelfed due to cost. Do you anticipate resuming any NDA type R&D in the future? Or do you think Elite will stick to mainly filing for large market and as generics? Is it possible to improve upon an existing generic drug with our control release or abuse the TeranTech and still is filed as ANDA? Or is that — is it necessary to file NDA?
A comprehensive question that have a lot of parts, so let me answer it this way. A few years ago, we shifted the company’s focus and we created a three-pronged approach. The three basket approach. One is the NDAs and the AR technology. Two is partnerships in order to elevate cost and bring in ideas and three is our own product. And all three are active at any moment if the circumstances are right, to move forward with NDA requires a lot of money, okay? And it’s because it’s the company. So will we do it now? No. Will we do it in the future when we have money? Of course, okay? Everything needs to be done in context. You got to figure out what do you have, what are you risking and what do you want to do, to protect the company. Can we use our technology?
Our technology is definitely usable and a lot of things, including something like Pfizer’s technology. We have the same technology as they do. So if there was a way for us to make a generic out of their OxyER, then that will be an ANDA Okay. Still keep in mind, we are still targeting a high-level generics because they are the most lucrative, lease cost and the best and fastest to the market. Has the BE trial started yet for the third needle mover, that is expected to be filed sometime in calendar year 2024? We do a lot of pilot studies that, of course, we do not announce because most of them are for you to learn, on how to modify their formulation. And once we are comfortable and go to a BE, we only announced that the BE passes. So we will definitely do that in this case if there is a BE trial and if it does pass, then we will announce it at that time.
A question on legal for OxyContin, I see this question a lot on investment message boards regarding the generic Oxycontin. My question for the next conference call is — is there a lawsuit pending regarding OxyContin? And if so, what are the details and circumstances that can be shared? As I said before, okay, Elite filed the Paragraph IV certificate with the — with its ANDA generic OxyContin and as that Elite got accepted by the FDA, after the ANDA, got accepted by the FDA, Elite sent the patentee, as we’re required by law, and the NDA holder, a notice letter. And that’s required by Hatch Waxman, okay. This was followed by a Patent Infringement Lawsuit, filed in the District Court of New Jersey by Purdue Pharma, standard procedure. Elite obtained an agreement with Purdue, to stay the litigation for six months.
Elite’s launch of the generic Oxycontin will depend on the approval by the FDA and the outcome of the various litigations involved with Purdue, okay? Or if the patent expired and especially those that are listed in the orange book, okay? A question about our partner, TAGI Precision Dose. I noticed in November 2023 that our three products with TAGI were changed from the TAGI label to Precision Dose label. What was the reason for the label change? Well, the honest reason is that because our partner/client requested it, said, we want to call ourselves Precision Dose, only from now on. And then they changed their mind, they want to keep some on the TAGI. But the — that’s really as far as we’re concerned. They asked us to do this to selling it, we’ll do it.
But the rest of the story is that the gentleman who started TAGI retired and sold his share to Precision Dosing. And now it’s a Precision Dose that owns both companies, and I think they are transitioning to one name only. There is no impact on Elite [indiscernible] server. Prasco Burel, are you still happy with the Prasco Burel agreement now that we have officially launched with them so far, are they selling our Adderall, as well as you hope? Look, they are a good partner. Prasco has been a very good partner. They have just started transition to us as a supplier, and they are doing very well. We have no complaints. Dexcel and international opportunities, any update on potential foreign market opportunities such as Dexcel. I’ll make a broad statement about Dexcel and any country outside of the United States.
All we can do okay, to support our partners with our FDA-approved data that we have. The rest is up to them, they have to take it to their country, work with the dossier, what’s required there, what’s their Ministry of Health. And every time their Minister of Health ask him a question, they come back and ask us to do more testing. And we’ll be happy to do it for them. And sometimes they ask you for stability. So you have to do certain things that are different than we do for FDA, we cannot interfere with that. That’s not our specialty. Our specialty is FDA. They handle their part, they’re successful, we launched and not successful, we don’t. We’ve been partners with Dexcel for a couple of years now, and we are looking forward to them getting some day and approval so we can launch.
