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Too bad I heard the same BS about BK, .02 cent "SOON", RS and Elite will never have enough money for a phase 3 trial. All BS.........and then the stock ran to .12 and then .97.
The next run is coming! Not if but when.
Gee and yet the head of the FDA has said he is going to push to get more ADTs approved - TRIPLE WHOOPSY!!
MORE BAD news for those betting against Elite!
http://www.businessinsider.com/opioid-painkillers-abuse-deterrent-formulations-are-they-helpful-crisis-fda-2017-8
Abuse Deterrent Coalition Sends Letter to FDA Commissioner, Scott Gottlieb
http://abusedeterrent.org/news/Abuse-Deterrent-Coalition-Sends-Letter-to-FDA-Commissioner-Scott-Gottlieb-.aspx#.WeyB8RNSwWo
Dear Dr. Gottlieb,
The Abuse Deterrent Coalition (ADC) commends the U.S. Food and Drug Administration (FDA) for its focus on the nation’s opioid epidemic by recognizing the promise of abuse-deterrent formulation (ADF) opioids to discourage abuse and incorporating expanding access to these medicines as a component of the federal Opioid Action Plan. The ADC is an organization of ADF technology innovators, patient and public policy advocates and pharmaceutical research groups that support the use of ADF for drugs that have high potential for abuse. We believe ADF opioids play a key role in addressing the opioid epidemic with a focus on prevention by deterring abuse and misuse of opioids.
It has been reported that you will be meeting in September with a group of pharmacy benefit managers (PBMs) and insurance administrators to discuss the opioid epidemic. We urge you to consider using this meeting to encourage PBMs and insurers to ensure that ADF opioids are available to patients with limited, if any, formulary restrictions to allow patients unencumbered access where appropriate. Ensuring access empowers providers to freely prescribe these therapeutically equivalent products with abuse-deterrent properties that are designed to deter tampering or manipulation in prescription drugs.
Unlike existing more easily-abused opioid products, ADFs often are subject to substantial coverage restrictions by PBMs and payers. Such policies have stymied patient access and created barriers to providers trying to prevent opioid abuse. We encourage you to address these formulary barriers to ADF opioids at your upcoming discussion. Such restrictions include prescriber impediments, prior authorization, formulary placement challenges, non-medical switching and “fail first” policies that prevent patients from accessing ADF opioids. These restrictions are counterproductive to addressing opioid abuse prevention.
ADF opioid manufacturers are working to replace non-abuse-deterrent opioids, which comprise 96% of all C-II opioid products sold today. Non-ADF opioids can be quickly and easily tampered with and abused through the intranasal and intravenous routes. The lack of consistent ADF opioid reimbursement may seem “pennywise” to PBMs and insurers, but it is “pound foolish” and comes at a significant public health cost. This Administration should use all options available to address both prevention and treatment to fight the opioid crisis – including the broader deployment of ADF opioids.
The FDA has publicly stated that it looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that lack abuse-deterrent properties. In response, ADF opioid innovators have begun developing, licensing and/or marketing medications incorporating novel technologies intended to deter abuse.
ADF technology is a means to help deter tampering and abuse of critical medications, while ensuring those who have a legitimate need for pain relief continue to have access to appropriate therapies. This technology is one innovative tool that respects the doctor-patient relationship for appropriate care while offering the possibility of deterring prescription drug abuse.
We believe it is consistent with the Agency’s Opioid Action Plan and in the best interest of public health to support the use of ADF opioids to balance the legitimate needs of patients in chronic pain while helping to protect families, physicians and communities from the burden of abuse.
Sincerely,
The undersigned Abuse Deterrent Coalition Members
10 FACTS of LIGHT leading to DOLLARLAND = $$$$$$$$$
1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.
our business is moving away from this type of revenue stream that is dependent on third parties.
2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.
4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.
5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation
6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.
7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.
8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.
9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.
10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches.
Sure k
Yeah I heard the same BS at .06 cents. Then it ran to .12 and then .97. Elite will easily see 35 and then some.
Another run will happen. Not if but when. And it'll start with the warning letter being removed.
Total BS on the stock tanking after every CC. That is complete and utter BS.
But hey feel free to post the PPS prior to and after every CC since Nasrat became CEO.
I'l wait........
I'll repeat myself......Why would you say we agree when clearly we do not? Notice the question mark. Next
There is no confusion. Elite made 700,000 a year in revenues - and then Nasrat came into the Elite picture selling Elite the generic products that lifted the revenue stream to 3.4 million. In other words that is complete BS that Nasrat had nothing to do with the increase in revenues. Again, glad I could clear up the BS.
Gee so prior to Nasrat coming into the Elite picture and selling Elite necessary generics, Elite made 700,000 and moved that 700,000 to 3.4 million. Go it - glad I could clear up the BS.
Gee and prior to that .036 to .24. But hey I was told a line of BS that a penny stock only runs once. LOL LOL
The next 10 bagger is coming from the existing PPS.
Got it so Nasrat has held gains for over 4 years. But hey another 20 years and maybe the .02 cent "SOONS" will still be another 20 plus years away. lol lol lol
Gee and here prior to Nasrat the revenues were 700,000. Next
Gee total BS. Revenues were less than $1 million prior to Nasrat becoming CEO and now they are $9.6 million and the company is moving forward on all cylinders creating new products.
The PPS was .068 when Nasrat became CEO and now the PPS is higher........I agree the market says so.
Total BS and the facts prove it.
Moving down the P&L statement, R&D expenses were almost $2 million this year compared to just over $1.5 million from the June 2016 quarter. Once again, just as important as the actual number is what was actually done to incur these expenses. And a lot was down during this quarter.
First of all, the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
We've also increased overall staff and headcounts to support product development. The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
During this quarter alone, we filed an ANDA at the beginning of the quarter, which will be relevant next year. We had a successful bio study for one of the products being co-developed with SunGen, which was a big deal and will be very important to us in the future. We also had another patent granted for our abuse deterrent technology. And we ran a lot of batches, lab test, analysis and generated critical data required to develop a wide and diversified product pipeline, all of that is important to Elite's future.
Subsequent to June 30, we added four additional products being co-developed with SunGen and also an entire line of products based on a unique drug delivery platform for extended release products which are also being co-developed with SunGen. And all of this is significant. So there is a lot going on in Elite's R&D.
Total BS. There is another 10 bagger coming only it will be in the land of the dollar.
10 FACTS of LIGHT leading to DOLLARLAND = $$$$$$$$$
1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.
our business is moving away from this type of revenue stream that is dependent on third parties.
2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.
4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.
5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation
6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.
7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.
8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.
9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.
10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches.
LMAO; remind me again what the PPS was when Nasrat became CEO. OHH that's right .068. WHOOPSY!!!
Gee like I said revenues will be over the predicted $5.6 million in revenues for fiscal year 2018. Next
Total BS. Fiscal year 2018 revenues- even with all the newer R&D expenditures will - will easily be over $6 million.
LMAO; appreciate the BS.........the difference my 10 bagger actually happened.
Why would you say we agree when clearly we do not? Notice the question mark. Next
LMAO; again, I've heard the exact same BS since the .06's. First Nasrat is too transparent and now not enough.
I'll stick to the facts not the BS.
Here are the facts:
10 FACTS of LIGHT leading to DOLLARLAND = $$$$$$$$$
1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.
our business is moving away from this type of revenue stream that is dependent on third parties.
2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.
4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.
5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation
6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.
7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.
8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.
9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.
10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches.
Well stated.........and on that note Nasrat has best speak to what he knows regarding the warning letter during this next CC ......... and he should keep in mind a bit of transparency would not hurt anyone.
Gee so now I'm told Elite is a POS and yet it is a penny stock that has hung onto gains for 4 years. Got it. LOL
Gee now why would you say we agree when it is clear when it comes to ELTP we don't agree on anything??? Notice the question marks.
LMAO; sorry I called the 10 bagger. It's a fact. WHOOPSY = LOL LOL - AHAAAA!!!!
Thanks for clarifying Elite doesn't trade on the Frankfurt. Next
Gee and here I've been waiting to buy at .02 cents "SOON" for over 20 years and counting.
I'm sure Elite will hit .02 cents in the Year of the Unicorn. lol lol lol
Gee Fiscal year 2017 - 9.6 million. It's in the SEC filings. WHOOPSY!!!
Gee more BS. Elite doesn't trade on the Frankfurt. Next
I heard the same BS when the stock was .06 cents - when I called a 10 bagger.
Another 10 bagger is coming from the existing PPS as well.
Total BS - SEC filings show fiscal year 2017 - revenues at $9.6 million. Facts don't lie. WHOOPSY!!!!
LMAO; yes I know another day when the .02 cent "SOONS" came yesterday as well.lol lol lol
LMAO; boo scary revenue are "falling" and yet Elite is putting time, energy, resources into newer generics worth way more than the existing breadcrumbs.
Gee let's see Nasrat becomes CEO at .068 and prior to him revenue stream was $700,000 a year and now the revenue stream is 9.6 million a year.
Investors understand the stock is highly undervalued here.
4 Andas already in with the FDA and another due to be filed any day now!
Remove the warning letter and UP we go $$$$$$$
LMAO - sure k just like Elite would never have enough money for a phase 3 trial. LOL LOL
Gee both complete as I most certainly called a 10 bagger and have proven it. WHOOPSY!!
Actually that is complete BS but thanks nonetheless. LOL LOL
Sort of like the BS that first nobody called a ten bagger ........along with Elite would never have enough money for a phase 3 trial = DOUBLE WHOOPSY!!!! LOL LOL