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  • Elite Pharmaceuticals (ELTP)--Intellectual Property (IP) And The Right To Devise A Better Pain Killer! [View instapost]
    A very thorough article on Elite's plans. The CEO noted that the investment community doesn't believe it yet but the products are going to be real. He is basically paid in stock and those that will benefit the most when the PPS begins to reflect this value are all the insiders at the company. And of course those that have come to realize there actually isn't that much competition for what is a huge market and have done their homework on Elite.

    Elite doesn't have to corner the market but even a couple abuse deterrent drugs and most will be set for life. Its a 20 billion dollar market and Elite's approach isn't some kind of miracle or new science. It is well established and really it is about the delivery mechanism to supply the opioid and the antagonist without releasing the antagonist.

    If they can do that, well they win and investors win. They already passed PH1 and Ph2 trials and are ready to enter studies for generics as noted and supported by a 10 million dollar financing agreement.

    Companies with 25 million dollar market caps do not become partners with major players in the pharma industry unless there is something significant behind it. Even Mikah Pharma which is a shell for Actavis basically notes on their website that Elite is developing and making their leading products.
    Jun 11 09:24 PM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    Actually Elite's tech is not that complex and I am unaware of any problems implementing it. The only items were scaling up commercial batches and funding for BE and PK studies. They now have 10m in funding available, The FDA has already approved the concept with Embeda but that is more complex because it is putting it all on one bead and is outlined in the FDA guidelines.

    Using separate beads makes formulating additional products much easier. In fact it makes studies much easier too. Once you can make one, you can make many.

    Beads of antagonist and beads of agonist. Beads of antagonist stay the same, beads of agonist adjusted for release profile. The company already believes it can submit for approval at about $1m per drug.

    What do you think it costs to ramp up and develop each hard shell drug that can be defeated? OxyNeo takes about 10-20 minutes to get it to where you can snort it. It is why Endo's drug was not given the same consideration. It is not even as good as OxyNeo. The FDA says OxyNeo makes it more difficult. That is deterrence, not resistance.
    May 11 04:53 PM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    Hakukin, Isradipine was the most important commodity? huh?

    Why did the third largest generic drug company come to Elite through shell company to develop a 505B2 NDA for them. Elite whose specialty is extended release and abuse resistant opioids?

    Hakukin, You want to really examine what is going on? Actavis gives Elite equipment to try and make Isradipine. Special equipment. Then we see Elite has applied for patents making micro-tablets of abuse resistant formulations. Microtablets .25mm....

    hmmmm coincidence?

    And where did Elite get Naltrexone and Hydromorphone ANDAs?????? Anyone, anyone?....yep the same third largest generic drug company in the world. Think just maybe the 505B2 product is an ART product?pretty obvious.

    And Naltrexone is the antagonist in all of Elite's abuse resistant formulations.

    Its just the tip if the iceburg when it comes to what Elite is working on, but the willingness to outright lie over and over again is certainly fascinating.
    May 11 02:27 PM | Likes Like |Link to Comment
  • 3 Companies Aiming For The $1.2B Opioid Addiction Market [View article]
    Also the question still remains, why did the third largest generic drug company in the world go through a "designee" to have Elite develop a 505B2 drug for them?

    Elite has other NDAs in development for other companies but a little digging will lead you to the why which is the Abuse resistance market.
    May 8 01:06 PM | Likes Like |Link to Comment
  • 3 Companies Aiming For The $1.2B Opioid Addiction Market [View article]
    You can read this other comments here which are mostly lies and misleading. If you want a good laugh, give Elite IR a call and ask about what he posted.

    I have responded to the continued lies in Karlefs previous comments and not wasting too much time on this

    I will hit one here quick so you see what you are dealing with

    "As for the "drugs" that have been approved, they are all very, very minor drugs that have been around for years, and that have well-established generic competition. The acquisition costs of two of the drugs (one being Naltrexone) have already been fully written off according to Elite's SEC filing, which suggests something of their value. "

    These are not minor drugs. Phentermine and Phendimetrazine sales via IMS only show about 50m total but most of the sales are through diet clinics. Qysmia has estimate revenues of several billion and Phentermine 15mg is the generic for half of that script.

    Regarding writing off Naltrexone. That drug is about to launch. It was written off the balance sheet way back when because the FDA required it to be approved via a prior review and it took so long to get approved it was written off that fiscal year. It was finally approved early this calendar year.

    There has been a group of folks willing to do and say anything to hold the price down. I think that is painfully obvious now to anyone that has been reading these posts.

    Like I noted, read all of Karlefs comments and you get an idea of what you are dealing with.
    May 8 12:54 PM | Likes Like |Link to Comment
  • Zogenix Poised For 40% Haircut As Zohydro Decision Approaches [View article]
    Nothing has been deleted? Really? where is your posts claiming Elite had no funding available that I responded to?

    Read the patents. Even Purdues patents. They all state that it is well known in the scientific community the effect of antagonists and agonists. Read the FDA guidelines I posted.

    You claimed 15 companies working on this approach then you try to claim that you mean abuse deterrent?

    Interesting that you bring up the yahoo message board. At one time there were 120 IDs being used to bash Elite. How many of them were yours?

    I am an investor no matter how many lies you tell or try to discredit me. Funny how I am focused on the stock and you are focused on me.

    The question is still here for you to answer.

    Why did the third largest generic drug company in the world come to Elite through a "designee" to have Elite develop a 505B2 NDA for them?

    If as you claim Elite is never going to be anything, what do these companies see in Elite to put their products and future revenues in Elite's hands?

    Actavis, Mikah, ECR. HITK, HK Pharma, TPN, TAGI, Epic, - all betting on Elite with generics and NDAs.

    Maybe you know better then they do but based on your continuous lies and deleted posts here, I am going to think they know a little better. I am also betting on the FDA, and USPTO who also discredit what you have posted here.

    So now you are shorting this class of stocks? Sure you are.
    May 6 11:41 AM | Likes Like |Link to Comment
  • Zogenix Poised For 40% Haircut As Zohydro Decision Approaches [View article]
    Now you are just making things up. Antagonists only effect a small portion of those that use them? What? They fill the same receptors in the brain as the opioid. This is just science. Just google it. If you go to the emergency room with an overdose, they will give you an antagonist like nalaxone.

    Here is the funniest part of what you posted. After saying that antagonists don't work which is plain silly, you go on to say that 15 companies are working on an antagonist approach.

    So first you claim it doesn't work, then you claim that 15 companies are working on the approach that doesn't work. If ti doesn't work, they why are 15 companies working on it?

    Now the truth is there are not 15 companies, only a couple (like 3) so if there are 15, you can settle this matter right now and name 10 companies right?

    You claim 15, I say name 10 of them with links that shows they are working on this approach (which you claim doesn't work)

    By the way, the FDA says it does work.

    The problems Pfizer has had with Emeba is that they couldn't make a stable batch because they were unable to control Naltrexone leakage. Again, because it is on one pill.

    Elite was actually way ahead of the game before they almost went bankrupt and spend 100m on developing products. The physical barrier products you mention can be defeated in a microwave and conventional oven. Read the FDA report on Oxycontin.

    So if I am a pumper employee of Elite which I am simply an investor, what does that make someone that has been caught lying here over and over about Elite?
    May 5 10:04 AM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    And the question remains, why did the third largest generic drug company in the world come to Elite through a "shell" to develop a 505B2 NDA for them. Elite whose specialty is abuse resistant opioids and Actavis who needs IP....
    May 4 10:31 AM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    About 85% of what you just posted is incorrect or misleading. I was about to go back through one by one but its not worth my time. You have been shown to be lying over and over already. One thing is for sure, you sure put in a lot of work to discredit a company with a 25m market cap. Now why would that be?

    Here is a list found online of what is going on with Elite.

    8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
    --4 quarters of increasing revenues
    --Lodrane 24 and 24D returning after being pulled by FDA with 500 other cold/flu products
    --Lodrane D OTC gaining market share
    --cash flow positive(CFP) probably this quarter
    --CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive)
    --interest paid in full on loans
    --ELI-216 Controlled released (CR) Abuse Resistant(ART) opiods are a priority, further along than people think per the CEO
    --1st patent for ELI-216 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012)
    --2nd patent for ELI-216 8/425.933 formerly 12/640,344(approval due week of April, 21 2013) combined with first patent, gives Elite a hammerlock on superior 2 bead ART(abuse resistant tech)
    --Patent pending 13/379,486 microtablet 0.25-1.0mm smallest in the industry for use with ALL medicines
    --Patent pending 13/379,481 microtablets for use with abuse resistant products
    -- 2 BEAD abuse resistant technology is a superior ART, it is Modular meaning it can be easily used for ALL opiods not just oxy
    --ELI-216 is a controlled release 24 hr abuse resistant oxy requiring Phase III clinical trials, after which it can be used for ALL opiods. Trials could start any time.
    --partner for ELI-216 could be announced any day
    --patent 12/075,816 Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn&Woodcock strategize to add more claims
    --Novel net worth growing, 31 FDA approved drugs including generic morning after pill
    --Elite owns 10% of Novel Labs, Novel has approached Elite for monetization
    --estimates for 10% value of Novel range from 10 million to 50 million
    --Elites 3.5 million debt will be eliminated with sale of Novel
    --current launched drugs continue to gain market share
    --phentermine 15/30mg launched (April 11, 2013) will compete with Qsymia(phentermine and topiramate)
    --BE and PK studies progressing, some maybe completed or near completion
    --New Jersey(NJEDA) tax credits approaching 1 million dollars/yr
    --Impressive billion dollar pipeline
    --multiple partners supporting Elite: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp and the undisclosed Hong Kong Pharma
    --contracting deals with other Pharmas
    --NEW Packaging line operational, making and saving the co. money, adding to the bottom line
    --TWO 15,000 sq/ft FDA-DEA-GMPc registered manufacturing labs for research, development and manufacturing from concept to commercialization
    -- 26 employees up from 16, 2 years ago
    -- 4-5 drugs in *Scale Up*
    --Hong Kong NDA progressing
    --MIK-001 probably an improved Embeda
    --HITK's 100 million dollar branded intermediate
    --first of 8 Epic drugs due out anytime
    --505(b)(2)opportuniti... for ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III trials)
    --STOPP ACT - a bill before Congress now, introduced by US Rep's Rahall, Rogers and Keating. The Gov. will prohibit any old-formula opiod from enterng the market if the FDA has an equivalent ART opiod approved
    --Naltrexone FDA approved, launch pending (May-June 2013)
    --undisclosed ANDA's could come out any day
    --CEO's goal is to comercialize a COMPLETE LINE of abuse resistant opiods
    --Relisting on NASDAQ 2-4 years
    May 4 10:28 AM | Likes Like |Link to Comment
  • Zogenix Poised For 40% Haircut As Zohydro Decision Approaches [View article]
    Except for the 10 million in financing they just received, and the ~10% of Novel Labs they own. And what you posted about the patents is nonsense as I noted already. I could go on and on but more nonsense will just follow.

    Here is a list of Elite's partners Actavis, Mikah, Epic, HITK, ECR, TPN, TAGI, HK Pharma, Novel,

    Here is what the CEO noted

    "It’s interesting to me that someone who worked on Wall Street for 25 years and disparity in valuation between companies like Elite and other companies involved in development of abuse-resistant products like Pain Therapeutics, Acura, what it says to me is that, the investment community doesn’t really believe us yet, but these products are going to be real. Well, there is lot of people in this company including myself and Chris and Carter, and our Chief Scientific Officer who have been paid a significant amount of stock because we do believe that. And that market has developed in a way enormously to our advantage, and we think we have an officious technology that is in a lot of ways superior to approaches that other companies are taking."
    May 3 09:46 PM | Likes Like |Link to Comment
  • Durect: Pfizer Hints At Progress With Remoxy [View article]
    Its probably not that small an amount. Per Actavis

    "Actavis anticipates that the agreement will represent more than $100 million in combined gross profit in 2014 and 2015, more heavily weighted to 2014. The agreement is expected to result in a more modest contribution from 2016 through 2019. Other terms of the settlement were not disclosed."

    There is the question of how does Actavis plan to get the IP for their own abuse resistance products, what will it be? They were making Embeda for Pfizer but had to divest when they were bought by Watson. Watson was sued by Pfizer for patent infringement over Embeda. This is the core of Naltrexone, covered over by the agonst and has had stability issues.

    There is a close tie to Elite Pharmaceuticals (ELTP.ob) that few would know. I have been beating this drum for awhile now. Elite is partnered with Mikah Pharma on an undisclosed 505B2 NDA.

    Turns out that MIkah Pharma is a "designee" of Actavis. And Mikah is basically a two person "shell" run by a current VP at Actavis.

    Elite also just launched Phendimetrazine for Mikah and marketed by Actavis. There are more connections between these companies than that but its a good place to start. Now why would the third largest generic drug company in the world come to 25m market cap Elite to develop a 505B2 NDA for them? Elite's main focus is abuse resistant opioids, just received 10m in funding and is entering studies for abuse resistant ANDAs and maybe a 505B2 per the company. They will own these products themselves.
    May 3 04:35 PM | Likes Like |Link to Comment
  • Zogenix Poised For 40% Haircut As Zohydro Decision Approaches [View article]
    This is hilarious. Agonist vs antagonist is a scientific approach. Elite's patents were awarded for their formulation. No one owns the approach but Elite owns their formulation. Elite proved which you can read int he patent docs that the polymers they chose exhibited unique and unexpected results when compared to those actually recomended by Purdue.

    They did a side by side test. Purdues recommended polymers, sequestered Naltrexone in a linear form as you added more polymer and leaked through the tested ranges. Elite's was parabolic meaning that once it hit a certain level, it began to shut down leakage exponentially until none was leaked.

    Embeda's problem is they try to layer polymers, coatings on a core of Naltrexone. Elite uses two micro beads. One has the agonist and one has the antagonist. They are separate. The best part is that this means that making each Opioid abuse resistant is basically modular. They are separate beads and if you can formulate the beads, which Elite can do, and if you can formulate beads of the agonist which Elite can do, you have an abuse resistant Opioid.

    Thats why they CEO noted his vision is a "line of abuse resistant opioids"

    Its simple, patented, effective and modular.
    May 3 03:52 PM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    Address what about Phentermine? Elite is about to be a profitable from operations company because of Phentermine. I just told you that the IMS revenue number for the three products is about 50 million dollars.

    You noted 20 competitors but that is 100-200% off.

    Methadone has been moved to the brand new facility so they can make larger batches. Methadone is what another IMS 40m plus drug. Actually probably a lot more since it is distro thru clinics.

    Not sure why you keep posting false information.....Well actually I am
    May 3 01:17 PM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    So you agree you just posted false information and now you want me to explain why the price dropped? There has been a ton of manipulation which you helped prove here.

    There was a supply issue with their Phentermine product line which was resolved.

    But the biggest issue is Elite despite once trading on the AMEX and almost going bankrupt a few years ago, they are relatively unknown right now. Also the products are being held under CT order.

    Here are some examples

    MIK001 is a 505B2 NDA partnered with Mikah/Actavis but no one knows what the product is and we won't until possibly trials and maybe not until approval.

    Hong Kong Pharma product - The name of this company is held under CT order. The SEC required Elite to note that this company has multiple FDA approved facilities overseas and we know the product is already marketed overseas but thats all that is released.

    Elite has either entered or is about to entere studies to submit a product for approval. We know they are looking at a few products for these quick ANDA and possible a 505B2 studies but we don't know the products except that they are abuse resistant opioids.

    Even the 100m branded drug partnered to genericize with HITK is not named although it should be approved soon.

    The company is holding their cards close to their vest for competitive reasons but we know that all of these companies did not come to little Elite (although they just doubled their manufacturing facilities this year) without good reason.

    We know they have an ANDA pending but we don't know what it is. It was developed in house at Elite

    The pipeline has some 24 products, 8 have been approved in the past 18 months or so but the biggest, the abuse resistant opioids are what will make the stock break out. Some of the other items may as well
    May 3 12:15 PM | Likes Like |Link to Comment
  • Why Did Pain Therapeutics Increase Over 25%? [View article]
    I see typical false information is making it's way from the yahoo MB cesspool to SA.

    Lodrane D
    Phentermine 37.5, 15mg(generic for billion dollar projected Qysmia), 30mg - Drug often not reported to IMS as it is sold through Diet clinics, weight loss centers -
    Phendimetrazine - Marketed by Actavis/Watson through Mikah
    8 drugs with Epic
    100m generic pending launch with HITK
    MIK001 - 505B2 with Mikah/Actavis
    NDA with overseas Pharma that already has multiple overseas FDA approved facilities
    Company is about to be CFP
    In House developed ANDA pending approval now - Suspected to be an Opioid

    This is all before the ART products.

    If you want the truth, do some DD< give IR a call. As you can see there is and has been an attempt to fool people about this company while it is being accumulated.

    Let me fix the lies above

    They need 4m not 5m to hit operating profit and the CEO noted, they expect CFP last Q. While also launching 3 more drugs and one more coming.

    The fully diluted count includes warrants and milestones shares on those 8 products so for them to hit, Elite would have an additional 8 products
    The "Diet" Pills have about 5-10 competitors depending on which pill you are talking about and total IMS is ~50m which doesn't include much of the actual sales

    Elite's Eli 216 already passed through Ph1 and Ph2 for their Oxy products.

    And the company owns ~10% of Novel Labs which has over 30 FDA approved drugs including the Plan B pill, another 50 in their pipeline, 200 employees. Elite's ownership in Novel is likely worth more then Elite's current market cap by itself. Look into it yourself.

    Ask yourself this one simple question

    Why did the third largest generic drug company in the world in Actavis, come to Elite through a "designee" to develop an NDA for them.
    May 3 09:37 AM | Likes Like |Link to Comment