Elite Pharmaceuticals Inc (QB) (ELTP) Quote

Yuuuup. Runway looking nice and…. green.

Soon. Go Elite

We’re likely more than half way to next product launch, codeine with APAP. Should see PR within next few weeks. 4 weeks have passed since Methotrexate launch. Looking forward to this opening up Perc & Norco launches.

That would be saaaweet She’s been Holding up Basing out nicely

Dollarama coming Soon !!!

James, I think it goes something like this..sorry it's long..lol..super busy but wanted to send you this to think about.

First I'll note that Accord is trying to get their legal fees paid for by Purdue now in the case where Purdues patents are ruled "obvious". That's as of yesterday.

However their other case is now 2025.

So it becomes about leverage. Elite doesn't need an approval to launch a partnered licensed version of Oxy. They could probably launch almost immediately after going through the usual requirements.

So if Purdue says, ok you won't make a deal? Let's go back to court and maybe it in another jurisdiction. Not sure on standing etc...but this stay is in place for a reason...

Now Accord won and is still dealing with this in another jurisdiction. Can they do the same to Elite? I'm not sure. Elite has its own patents too especially around time release. If I get some time I can go back through the other case.

So if you are Elite, what are your options? File a motion to dismiss? Wait for approval and pdufa is upon us. But if Purdue can find another legal angle, they can delay probably another 6 months. They obviously aren't concerned about legal fees...

That is their only leverage. Can we get a sneak under the radar approval ? Maybe but even then I think another lawsuit pushes us 6 months if FDA says wait....

And if Accord has the first to file which I believe they were informed they have as I noted from the court documents...can we also get first to file status? That answer is actually yes but it seems convoluted but it fits this scenario from what I read...one company held for patent.

So now you are playing a game of chicken with Purdue and the FDA? Roll the dice?

That's risk. You can eliminate all of it if you make a short term license deal. Still get your approval and have your own ANDA that you would use when the license with Purdue runs out...

Meanwhile, Accord is still in legal purgatory.

So there's benefit. Purdue keeps Accord on hold, we make money now and still can have the ANDA later. It's risk management.

Also, don't let the perfect be the enemy of the good. It would be a win win for both parties....or roll the dice again...we will win either way. One way might be better. We will see .

It's super fascinating....and for.the record,.I hate Purdue. Lol

There are no insider sales.

It also said the stock is a very “high risk” stock It was rated a hold not a buy

Insiders are Very Positive Buying More Shares Than They Are Selling In Elite Pharmaceuticals Inc

In the last 100 trades there were 545.08 million shares bought and 326.53 million shares sold. The last trade was made 179 days ago by Hakim Nasrat A who bough 49.53 million shares. The large amount of stocks bought compared to stocks sold indicate that the insiders believe there is a potential good upside. In some cases larger purchases can be explained by due date for stock options.

https://stockinvest.us/stock/ELTP

Wow That was some explosin !

Stacking a lil'.......... Gonna explode. They're trying their best to keep this thoroughbred in the stable. ELTP wants to run like American Pharoah. LLLLLLLLEEEEEEEETTTTTTS GOOOOOOOOOOOOOO !!!!!!!!!!

My favorite favorite phrase my next favorite phrase which we’re going to see soon is Dollar land landing!!!!

I am golden at $1 - anything above that is gravy

At $5 I assure my kids future too

Give me 5 dollars and I'll sell!!!

DollarLand for Christmas

GLTY

Stock is very strong$$$$$$
Eltp$$$$$

Watching for the break out of the Bull Flag, only a matter of time.....

Interesting read about google searches
https://medicalxpress.com/news/2024-09-google-trends-reveals-surge-adhd.html

I always thought Adderall could help with covid brain fog

Ihub is way to slow today, thats how double clicks happen

The bid and ask is just way to tight, right now 3801 bid 381 ask

stacken for sure

and this I hub is way too slow

PULLED TRANSCRIPT FROM LATEST CONFERENCE CALL:

Sales and distribution is what's really leading our increase in revenues. Elite's transition to direct sales with our Elite label has been a great success. The revenue and profit growth demonstrates that success. A testament to our great team, especially Doug Plassche in the operation team, and Kirko Kirkov and his sales organization and the rest of my senior staff. Everybody is doing an excellent job coming together to get us to where we're at.

The highest revenue generating products for Elite label continue to be the mixed Amphetamines, IR (390 Million) , and ER ($1.56 Billion) We see strong market demand for these products. The sales are limited only by how much quota we can get. Managing the quota for these products is very important and our team has done an excellent job managing the quarter. Our other products, Phendimetrazine, Isradipine, Trimipramine have achieved smaller revenues than Amphetamine, but they have strong market shares and they are contributing to their revenues substantially.

In addition, to sales for the Elite label, we also have two licensees, Prasco. Prasco has a non-exclusive license for the Amphetamine ER and sells under the Burel label. This product was launched the first quarter of this year and is doing well. Precision Dose has a license for Naltrexone and Phentermine tablets and capsules and they sell under the Taggy name label and Precision Dose label.

Naltrexone continues to be on the FDA shortage list. Elite has other products that will enhance our pipeline, substantially increase our revenues that will be launched soon.
1. The first product is generic Methotrexate $63.4 Million - DONE . Methotrexate was recently approved by the FDA and will be launched this quarter.
2. The second product is generic APAP with Codeine $45 Million. The brand name is Tylenol and Codeine. APAP with Codeine was approved a few years ago, but we waited until we saw a market need before launching it. We believe the time is now. We expect the launch of APAP with Codeine to be shortly after Methotrexate, six to eight weeks.
3. The third product is Oxy APAP $500 Million, which is Generic Percocet. We expect to launch Oxy APAP six to eight weeks after APAP with codeine.
4. The fourth product is Hydro APAP $477 Million which is the generic for Norco and that will follow Oxy APAP.
5. The fifth product is Methadone $30 Million and we will launch that after Oxy, Hydro APAP. Of the five products that I mentioned, Elite would launch at least three within the next four months.
6. The sixth product to be launched is the central nervous system attention deficit disorder product (GENERIC VYVANSE, pending FDA approval 5.1 Billion. This is the most important of all the products I spoke of. This product will have launch priority over all other products once approved. Now we can only plan for what’s in the queue and what we have. We have everything we need to launch the central nervous system attention deficit disorder medication. Once the FDA gives us approval, we reprioritize everybody else and this will go next.

Elite maintained a strong cash position during our transition to sales. We have supported working capital needs as well as R&D pipeline cost, while maintaining our cash levels. The new product launches will substantially increase our profits and revenues. We will see incremental increases over the next two to three quarters.

Nothing’s going to happen overnight. You launch the first product, you’re going to go through the growing pains that Carter described and then starts to become viable. You launch the second, you go through the same thing. So it’s all coming, and it’s coming quarter-after-quarter.

Regarding the research and development pipeline, Elite has three ANDA filed that are under review by FDA. Generic dopamine agonist ANDA for the treatment of Parkinson’s, and ANDA for the treatment of pain management OxyContin ($720 Million), and the central nervous system stimulus ANDA (Vyvance) $5.1 Billion used for ADHD FDA reviews continue for these products and Elite continues to provide support to any FDA request. Elite will issue a PR upon approval.

Now, two of the three products that I mentioned are needle movers. So let me say a few more words about that. Regarding the CMS application, the FDA asked us to make a couple of minor adjustment. Tighten the spec, move this over here and there, nothing of relevance. But the FDA did request an extra month to review the DMF for the API supplier.

So our PDUFA date is November. That was very nice of FDA to do that, because they found that our application itself doesn’t have any issues or all the issues we had, we resolved them over the past year. They had a question to the DMF supplier, and instead of saying, take this back and call us back in a year or in six months or whatever, they actually said, we need another month to resolve some issues, which is really very promising. And we will update you in November once we hear – if we hear from FDA and what their verdict is.

Regarding second needle mover the pain management and generic OxyContin ($720 Million), it’s one of the common outcomes of a paragraph IV ANDA filing is a lawsuit by the brand company, and we have updated you on that. We’re going through that right now. We agreed with Purdue to renew the litigation hold for six more months. It does not make any sense for us to get engaged with lawsuits with Purdue at this time, because they have enough people suing them and trying to invalidate their patents. So we stepped back and agreed that we will take six months where we don't go through discovery, we don't have to spend the money, they don't have to come after us till we see what's happening in the landscape. If a judge says patents are invalidated, will move in. If they say they are not, we're in the same boat as everybody else.

Elite has other products in the formulation development stage that have not reached a reportable milestone yet. Elite continues to make R&D a priority……... Regarding the facility and infrastructure, as you know, to keep up with our growth, we needed additional space. So we have taken on an additional 34,000 square feet to support expanding packaging, inventory and warehouse holding.

We closed the deal and took possession of the facility last January. The permits were obtained for construction because it's a part, 34,000 square feet is a part of a building that's about 85,000 square feet. We have to seal it and close it to make it into pharmaceutical. We build the IT infrastructure, the servers, the cameras, ADT security, all of them are ready. A state of the art packaging line that's already been qualified and ready. Department of Health got approval, then the CDS approval. The two remaining things were DEA and FDA.

The vault and all the security already. We invited the FDA last week. They showed up Monday, and I am happy to report that the inspection went very well. In my opinion, the DEA takes, usually regulatory agencies in general take 45 days to write the report. I expect approval by the DEA within that time. Before we meet in November for sure, but I believe within 45 days we'll receive approval from the DEA.

The next step is FDA – next and final step is the FDA approval. To get the FDA approval, we have to manufacture or package lots at the facility, put them on three months stability, and then file with the FDA for them to come in and inspect and give us approval. The lots are being packaged right now. The lines are qualified, including serialization, all of that. They are being made right now placed on stability by next week or the week after. Three months should be about November, I expect that we’ll file towards the end of November, and then it’s a matter of when the FDA can approve it and we’ll update you on that once we know. At the end of the day, once this facility is approved, we should have and be covered from the expansion standpoint for at least five years for manufacturing and longer than that for packaging.

In summary, Elite has shown strong growth this quarter. We are executing the company’s strategies for commercial, sales and distribution and research and development. Elite has the best commercial product line it has ever had an excellent pipeline of approved and soon-to-be approved products, and the best financial position in the company’s history.

This puts Elite in a strong position for an M&A or a move to NASDAQ when the time is right..

I see MM GTSM is up to their old tricks again, or as I like to call the (gypsies)
they had 158k at 38 and as soon as it went to 3851 it disappeared lol
never hit 38

Thanks DNORWOOD - God bless

I think if Vyvanse is approved it will be worth $1 by itself over time, but not right away. Hoping we get that approval soon without delays. Would be absolutely huge.

How bout we get to 50 cents first lol Stop the BS You have no idea what the price will be

Great news out of Jersey coming soon. Cheers.

thank you for the reply

Following the plan disclosed on August 15th - by the way, we will get a bump for each launch, but for Vyvanse, approval will suffice to account for Vyvanse EVENT as if it was launched. After that, we will live for a while off of the actual results every quarter - and as the revenues grow, the company value will grow with the PPS and the P/E ratio.

what approvals have you included in your calculations in this case?

Hi, Thank you for asking - I think by end of November we should be at $1.40 based on my calculations. If there are some delays, maybe end of December - Merry Xmas and Happy New year.

what are your speculations regarding the stock price's reaction to following news such as approval of OxyContin, Vyvanse or the approval of the new facility? how much could the price grow in each instance?

During the August 15th teleconference, Elite Pharmaceuticals, Inc. (ELTP) highlighted several key points:

1. **Financial Performance**: The company reported improved financial results, including increased revenue and profitability compared to previous quarters.
2. **Product Pipeline**: Updates were provided on the progress of their product pipeline, including new drug applications and upcoming clinical trials.
3. **Strategic Partnerships**: ELTP discussed new and ongoing strategic partnerships that are expected to enhance their market position and drive future growth.
4. **Regulatory Approvals**: Information on recent and anticipated regulatory approvals for their products was shared, which is crucial for market expansion.
5. **Market Expansion**: Plans for expanding into new markets and increasing their market share in existing ones were outlined.

These points likely contributed to the positive market reaction and the subsequent increase in ELTP's stock price.

Agreed 👍

Just remember one of the most important factors that made all longs money in ELTP. Paid negative sentiment. Have you noticed the hysterical fear the shorts are showing? Making fake IDs on yahoo, harassing people on ihub. This is GREAT news. It means there is a lot more money to be made. Enjoy the next wave. Remember when it was down to 12 cents after hitting like 16 to 20 and they said it was going back to 2 cents? Oooof, I wonder how many hundreds of millions they lost on that call...

up .00005 gotta laugh

250 K on the bid, that's odd, could take all day

Is it not only plausible, but probable that at some time in the not-too-distant-future, when Elite has reached and exceeded It's current set of goals, Nasrat will attempt to penetrate foreign markets? -Just a thought sparked by the recent China stimulus news. "Think globally. Act locally." and all that.

Haha. . . "Money talks. . . "

Yes, soon. Thanks and go Elite

Lots of news Imminent:

X 1. Cash Flow Positive - 5 years
X 2. Purchase building housing their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products.
X 3. Adderall IR $335 Million IMS market Approved and Launched
X 4. Adderall XR $1.56 Billion IMS market Approved and Launched
X 5. Double digit quarterly revenues in millions
X 6. Create in house marketing and distribution: Kirko Kirkov, Doug Plassche and their teams
X 7. Prasco/Burel Adderall agreement - January 1st 2024
X 8. First shipment Adderall XR to Prasco/Burel Dec 2023
X 9. DEA increases manufacturing quotas for Adderall & Vyvance
X 10. Generic OxyContin - FIRST TO FILE FDA Aug 17, 2023 $720 Million
X 11. Generic Vyvanse - $5.1 BILLION - FDA submission Dec 2023
X 12. FDA Acceptance of Generic OxyContin Sept 2023
X 13. Lease additional manufacturing space and storage vault for new Needle Mover ANDAs - Jan 2024
__14. Dopamine Agonist Approval (probably Requip XL or Mirapex ER). $12 Million
__15. Obtain Full ownership of Adderall IR $ 335 Million from MIKAH
__16. Obtain Full ownership of Adderall XR $ 1.56 Billion from MIKAH
X 17. Vigabatrin Approval $233 Million
X 18. Pyros Vigabatrin -settle VigPoder trade mark challenge and LAUNCH
X 19. Generic Methotrexate Antimetabolite- Approval
X 20. Launch generic Methotrexate $63.4 Million
X 21. $50+ million in yearly revenues
X 22. Lowest PE ratio for OTC Healthcare sector
X 23. Become the ONLY company showing rapid growth on the OTC while being profitable
X 24. Put Opioids back on the Table- due to reduced risk of opioid litigation
X 25. Receive Analyst Coverage - Upgrade to Market Outperform - Zacks Investment Research
__26. Generate revenues over $20 million/quarter
__27. Final Approval of New Manufacturing Facility/Expansion
__28. Double output of manufacturing and packaging facilities
__29. Launch approved generic Tylenol with Codeine $45 Million
__30. Launch approved generic Norco - hydrocodone acetaminophen IMS $477 Million
__31. Launch approved generic Percocet - oxycodone acetaminophen IMS $500 Million
__32. Launch approved generic Dolophine - methadone HCL tablets IMS $30 Million
__33. Generic Vyvanse Approval and Launch
__34. Generic Concerta- FDA submission $1.2 BILLION
__35. $100 million in yearly revenue
__36. Generic OxyContin Tentative Approval $720 Million
__37. Elite prevail over Purdue in Generic OxyContin infringement suit - second 6 month stay - active Accord/Purdue suit causing delay
__38.Launch generic OxyContin $720 Million
__39. Resume R&D on SequestOx Abuse Deterrent Oxycodone
__40. European distribution - Dexcel partnership approval by Israeli Health
__41. $200 million in yearly revenue
__42. Patented Unique ADF (w/o naltrexone) drug C in SequestOx reformulation trial
__43. Undisclosed Mikah ANDA(s)
__44. Undisclosed ANDAs/NDAs
__45. Generic Concerta Approval and Launch
__46. DollarLand PPS
__47. Big Pharma bid
__48. UpList to the NASDAQ Exchange
__49. ELTP Elite Pharmaceutical Buyout - 2 1/2 years or less from Feb 2024
Bullish

I really wish Elite would post some news. Yes I’m back at the request of money. Appreciate your support

I meant to say Entering Tuesday-Thursday PR zone

$3 $5 buyout

1. Methotrexate $63.4M
2. Tylenol with Codeine $43M
3. Percocet $500M
4. Norco$477M
5. Methadone 30M
6. Vyvanse$5.10 Billion

7. Dopamine Agonist $12M

8. OxyContin $720M

9. Concerta $1.16 Billion

https://www.barchart.com/stocks/quotes/ELTP/opinion

According to the chartist we should go up today,
we have a bit of a pennant going back to the 13th, and have had three lul , or flat days

Entering Tuesday-Thursday or zone.

Elite has been working on generic Concerta for a long time. My guess is that is where a lot of Elite’s R&D dollars are being spent. A positive BE study for Concerta would be a major catalyst for ELTP. It is a difficult product to replicate, hopefully Elite can do it.

Hi James, I like your way of thinking - this is indeed a discovery.

We see how Nasrat was able to find API for Adderall where other manufacturers are dry

Kudos !

Agreed. I also think Concerta would be huge. Would be nice to see a positive BE trial soon.