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I agree, I too saw this in the Q... these three will be Elite’s staples every quarter until the big boys ramp up.
Thank you... I don’t remember reading it before
Subsequent to December 31, 2019 and up to February 4, 2020 (the latest practicable date), a total of 5,337,102 shares of Common Stock were issued to Lincoln Park, with such shares consisting of 5,265,484 purchase shares and 71,618 additional commitment shares. Total proceeds from these transactions was $517,037.
I found this to be most interesting.. thoughts??
The abuse-deterrent opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach. These products are combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse of the drug. Both, agonist and antagonist, have been on the market for a number of years and sold separately in various dose strengths. We have filed INDs for two abuse resistant products under development and have tested products in various pharmacokinetic and efficacy studies. Products utilizing the pharmacological approach to deter abuse such as Suboxone®, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda®, a product marketed in the United States by Pfizer, Inc., have been approved by the FDA and are being marketed in the United States.
We have developed, licensed to Epic the marketing rights to SequestOx™, immediate release Oxycodone with Naltrexone, and retain the rights to the remainder of these abuse resistant and sustained release opioid products. We may license these products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
We also developed controlled release technology for oxycodone under a joint venture with Elan which terminated in 2002. According to the Elan Termination Agreement, we acquired all proprietary, development and commercial rights for the worldwide markets for the products developed by the joint venture, including the sustained release opioid products. Upon licensing or commercialization of an oral controlled release formulation of oxycodone for the treatment of pain, we will pay a royalty to Elan pursuant to the Elan Termination Agreement. If we were to sell the product itself, we will pay a 1% royalty to Elan based on the product’s net sales, and if we enter into an agreement with another party to sell the product, we will pay a 9% royalty to Elan based on our net revenues from this product. We are allowed to recoup all development costs including research, process development, analytical development, clinical development and regulatory costs before payment of any royalties to Elan.
This is why Elite is selling some of the pipeline... to save $1.1 million dollars..
The FDA’s Generic Drug User Fee Amendment (“GDUFA”) fee structure includes fee brackets that are based on the number of ANDAs owned as of the April 1st annual measurement date. As of the measurement date in 2018, the Company qualified as a medium sized company, which is defined as an entity that owns between 6 and 19 ANDAs. During the fiscal year ending March 31, 2019, the Company received approval for several ANDAs, which, when added to those approved in prior periods resulted in the Company owning in excess of 19 ANDA’s and would have required classification as a large sized company as of the 2019 measurement date. Based on the latest fee schedule published by the FDA in August 2018, the annual fee for a large company is $1.1 million higher than the fee we paid as a qualified medium company. Qualifying as a large sized company would accordingly result in a significant increase in annual regulatory fees.
Acetaminophen and Codeine Phosphate, USP CII (generic version of Tylenol® with Codeine)
On September 18, 2018, the Company filed an ANDA with the FDA for a generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate) 300mg/15mg, 300mg/30mg and 300mg/60mg tablets. Acetaminophen with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Acetaminophen with codeine products have annual U.S. sales of approximately $45 million according to IQVIA (formerly QuintilesIMS Health Data). The Company received approval of this ANDA in September 2019. Elite has not yet launched this product and is seeking a partner for this product.
Those wondering about SequestOx.. Elite shopping for a partner to absorb cost..
The abuse-deterrent opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach. These products are combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse of the drug. Both, agonist and antagonist, have been on the market for a number of years and sold separately in various dose strengths. We have filed INDs for two abuse resistant products under development and have tested products in various pharmacokinetic and efficacy studies. Products utilizing the pharmacological approach to deter abuse such as Suboxone®, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda®, a product marketed in the United States by Pfizer, Inc., have been approved by the FDA and are being marketed in the United States.
We have developed, licensed to Epic the marketing rights to SequestOx™, immediate release Oxycodone with Naltrexone, and retain the rights to the remainder of these abuse resistant and sustained release opioid products. We may license these products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
We also developed controlled release technology for oxycodone under a joint venture with Elan which terminated in 2002. According to the Elan Termination Agreement, we acquired all proprietary, development and commercial rights for the worldwide markets for the products developed by the joint venture, including the sustained release opioid products. Upon licensing or commercialization of an oral controlled release formulation of oxycodone for the treatment of pain, we will pay a royalty to Elan pursuant to the Elan Termination Agreement. If we were to sell the product itself, we will pay a 1% royalty to Elan based on the product’s net sales, and if we enter into an agreement with another party to sell the product, we will pay a 9% royalty to Elan based on our net revenues from this product. We are allowed to recoup all development costs including research, process development, analytical development, clinical development and regulatory costs before payment of any royalties to Elan.
That makes sense...but why do some release during hours???...do they just not care who has the advantage?
No on both accounts IMO.... we will have record revenues and there could be a slight run up into the teens... but until we get revenues from Adderall XR, which is probably going to be six more months. I just don’t see the manipulation of the share price ending yet. Just my opinion though.
I know we usually release financials after the close but I really wish they would release them at 1pm eastern time when the market is still open.
Any know why most release after hours? I’m sure there is a very logical reason that I can’t think of.
“the SP will not move simply due to the fact the outstanding shares do not support the current revenue “
So now we agree.... CURRENT REVENUE being the key here.
Agree JJ.... I still think we are probably six months away from any big significant move...IMO....
It’s coming in April
It will be a much bigger celebration next time Jimmy.
What list..??... show me the list....all this talk of successful OTC companies with better share prices that are CFP with revenue over $10 million a year... and Elite is going to crush those numbers.
Puny revenues are claimed here... come on let compare apples to apples....
Wrong... so if Elite moved to .50 share price with 1 billion shares outstanding... what changed???.. only revenue and then profit will move this stock...
Gee I missed the list of all the successful companies that have a .10 share price that are cash flow positive..
Again please list all the companies on the OTC that are cash flow positive with over $20 million a year in revenue..
We have no control over the share price.. We can only control making more money. Thanks
At some point. The manipulation of the share price will end. Buying pressure will win out.
We have an opportunity to have a few weeks in a row of good news coming our way. PR’s could be rolling in .. the timing is right on several fronts.
Once the volume increases and alerts are triggered. Lots of new eyes coming in..
Now I get it sharkey1 .... Hey how exciting would $10 million be?..
Thanks so much for your post... Your experience In this field is a valuable and welcomed need to the board...
Our time is soon coming. Have a great weekend GLTY
Winechemist has gone over this before with all the moving parts with a launch. I can’t remember the whole post but it was about making batches and getting them tested if I remember.
I also thought but what Nasrat said when it was approved that we would see the launch before our CC and I’m still hoping that will happen Monday. But either way we should be very close.
Maybe Winechemist will weigh in again. I know he reads the board but doesn’t post much.
So being 0-10 if the last calls just before the CC hasn’t stopped another ridiculous one appearing I see...Do you ever get tired of being wrong?... How do you just erase your track record from memory... it’s a true gift.
Great to here from you again.... 10% wow we can only hope we get that right out of the gate... thanks again
Haha....”slowly grow”... are you at happy hour?...
If you were CEO and had over $160 million shares of the company.
Wouldn’t you want to get paid at some point?..A buy out or merger is the only realistic way for that to happen ..
Like it or not.. it will happen here GLTY
Well then you would know that they usually don’t release that info publicly..
The answer is... I believe they were a private company
Patience my friend... lots of moving parts...waiting is hard.... anxiety is real... the day after they launch we will just be back waiting for something else..
Ok I’ll play..6.6.... thanks
It definitely does give ammo for a few to use LOL... but most realize Elite is just moving forward quarter after quarter now.. and it breaks up the monotony of waiting for news.
Yeah guess would be on the lower end between 6.2 and 6.8.. The profit sharing split is the question mark.. Lannett gets a cut and Elite and SunGen... will be very interesting to see some real numbers in the Q...
Wow... I’m getting really excited over some of these predictions... I know, I know.. they are really only guesses but it’s nice to think of the possibilities...
Wherever we land somewhere between 6-10 million... no one can argue with this next launch, due any day... Elite’s future is very bright and changed forever....
I already thinking about the year end numbers... GLTA
Lannett to report this Wednesday after close... I think we will get a PR about our joint launch sometime before them reporting. IMO... should be a good week... GLTA
I’m glad I’m locked and loaded and do my own DD...Sure would be sad to miss the next run after being here for years...
Might want to research companies doing more than 20 million a year in revenue that are cash flow positive...
Good luck
So with this logic.... when the PPS catches up with the true value of the company. Then all of a sudden, the partnership is successful????... seriously flawed for any investor who has been around for awhile.
Constant*
With the FFF...?????... what is that..???..we just more than doubled our revenue basically from a SunGen drug.... so there is that....
We are going to report somewhere between 6 and 7 million of revenue in just over a week because of our partnership with SunGen...
The consent correlation with the OTC and major markets based on the PPS is seriously flawed...
Excellent N2k.. and absolutely along the lines with what Nasrat and team expressed at the shareholders meeting.
Good work.. great DD...can we just skip right to the financials and the CC please...???.. exciting times..
We continue.... please provide a list of all the penny stocks that are CFP ( cash flow positive) with reoccurring revenue quarter over quarter with the potential revenue of 20 + million this next quarter.
Throw in our pipeline, patents and facilities...yes, buy out or mega merger is a certain here...I will wait for your list.. thank you