All right. So the first question, can you provide PDUFA date insights for opioid analgesic and other filings. It’s GDUFA not PDUFA. And the general rule is that you’ll get a response in 10 months. The response could be, hey, you need more work, which is called complete response letter, or hey, you’re approved. But the FDA is obligated to give you a response in 10 month, okay? What that response is going to be? We don’t know. We’ll wait until the FDA says that, but the general rule for everybody in the industry, 10 months, and you will get an answer. Now after the 10 months, if the answer is that, I still need you to do something doesn’t mean it’s rejected. All that means is go do that, and I’ll approve you later, but now you’re not under a PDUFA fee.
The FDA doesn’t have to take it up and give it priority over anybody else. Any update on the dopamine agonist? Any update on the central nervous system stimulus that recently had a positive bioequivalence study? Yes. As I stated, we will issue a PR once we have an acceptance for review by FDA. We haven’t seen that a CNS product filed yet. This one seems to be taken longer to file as per positive DEA results that — than usual. Are we still tracking to file soon? And if so, when? Let me take a minute to tell you that the assumption is not true. Pharma company is manufactured an exhibit batch, just a single batch out of the set of dosages that you have. So if a product has five different strains. They’ll pick the one that’s supposed to go into the clinical trial and make one batch and run the clinical trial.
If they pass the clinical trial, then they go ahead and make the rest of the lots, because it costs a lot of money. So if you have five dosages and you run a clinical trial with one and you pass, then you have to go back and make three batches of each strains. That’s 15 lots. Plus, if you want a second, somebody have to do five more. So 20 lots have to be made after you pass the clinical trial and put on stability. Mandatory six month stability for accelerated and control room temperature. So manufacturing the lots take a couple of months. The stability is six months. That’s eight units tested, that’s nine and regulatory affairs needs to compile the ANDA, that’s at least another month or two, that’s 10 or 11 months. So we made announcement at the end of August.
If I can remember correctly, August 28 of 2023, that we passed the BE. 10 months from then will be June 2024. And this is — the filing is happening now. So I think that we’re moving at lightning speed. And that’s because we took chances and we made the lots at risk because this was an important product and our data was solid when we’re going to pass. But under normal circumstances in the future, look at 10 months after the clinical trial testing for filing. That would be reasonable anywhere in the industry. Can you provide insight into pipeline progress? What our filings expectations for 2024? I expect that we file at least two more in 2024 and hopefully get approval for four. That includes the two needle movers. When does Elite plan to diversify away from CNS and opioids?
I’m not sure why would we do that. We will add to it. And I just went through the list we have, high blood pressure medications, we have bariatrics, we have massive relaxants. We have a lot of other products. And as long as the product is popular, serves a purpose and it creates revenues and profits, we’ll stick with it. When do you anticipate filing the third needle mover product, assuming trial time line goes according to plan? Next year, 2024 will be the time. Some questions about Presco. Details you can share on Presco agreement? Well, Presco is the authorized generic — they’ll be buying the product now from Elite instead of the brand. It hasn’t been easy, because we had to obtain quota just for them, supported by their data. But we are making lots, and they expect to launch in January of 2024, and we’re going to be there right with them.
They were received what we promised them in December. It’s a win-win for both companies. It’s a very exciting opportunity, and that’s going to add quite a bit to our revenues and profits. Does Presco get to keep their prior Adderall quota for us to manufacture? No, that’s not the way it works out. As a matter of fact, according to Presco, they never had to deal or think about quota. It was the brand company. Brand companies get all the quota they want. So they were selling the product to Presco, putting it on the label and Prasco was selling it, but the quota does not come with it. Has Elite been able to increase their quota for API for Adderall generic? The DEA has been signed, they have giving us what we need to stay in business. Corporate operation, when will fiscal calendar year — fiscal and calendar year align?
