pagiantmetknicksfan@yahoo.com
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There have been a number of questions disprovng the "facts" left unanswered, claims made without links disproven with links, conference calls listened too where no link can be provided despiteit bing months ago when DD started days ago. Of course the most interesting piece is regarding the recent updates on the Eli 216 patent and the likelihood of getting that massive product to market.
I guess based on this response you are unable to provide that information, answer those questions, provide the links etc...
That is just a bunch of data and copy pasted. Take a look at all the questions I asked, links requested. This doesn't address any of that. The information included here actualy proves why elites tech is valuable.Also if you copy data from publications, you should include links.
If there are all these studies and patents out there and the market is billions of dollars, how come all the billion dollar drug companies don't have meds out there now? Elite is PH3 pending too. It is because the Naltrexone is hard to sequester but the patent actully being discussed is Elite's tech has been able to that.
Anyway, see if you can address the items actually discussed. The list is growing.
Convincing of what exactly?
I still haven't seen those links to those "facts". I am not sure what you are referring there.
So many of those "facts" have been disproven by actual data or by questions that completely make those "facts" seem more like opinion without basis in fact.
Then provide the links. Answer the questions challenging those facts or noted as sources of those "facts". I continue to provide links in fact refuting those claimed "facts" as well as facts explaining my though processes on these items.
"Experienced investors know that a patent approval is unlikely to move the pps at all." Really, a patent for a PH3 pending 800m marketed drug described as a "homerun" and "extremely valuable"
Do you have a link for this because I have seen numerous stocks blow up on patent news, especially OTC companies. This patent is what the company was built on.
It is the reason why Elite used to trade in dollars
Seems maybe you missed the previous questions and notations of all the incorrect facts you presented.
Let me summarize
If there are so many patents out there which you somehow managed to read everyone in a few days, how come there are not tons of new abuse resistant Opioid pills out there right now?
I keep asking this question but have not seen an answer. All of these patents, yet where are the products? It is a multi billion dollar market and Pfizer, Purdue, Novartis, Bayer can't seem to get any pills to market?
Stated fact of 3 years being a long time for a patent to be approved.
Actually avg is 3.5-4.5 years. Here look, an actual link.
http://www.iphandbook.org/handbook/ch10/p09/
Can you provide any of the links requested so far?
Can you provide those patent #s?
I asked for your impression of the Oshlack patent in light of Kibbe and Wright. Do you have a response, maybe I missed it?
I realize that reading thousands and thousands of technical, medical, scientific pages in a few days is quite an amazing feat, but I was figuring the key point to Elite getting the patent would be important to spend special attention to.
You noted you just started your DD on this company a few days ago and listened to the conference call from a few months ago. I think it is very important for everyone to hear that conf call that has an interest in the company. Sometimes the tone and excitement and confidence in peoples voices is as important as what is said since they can often not be allowed to reveal everything about a subject.
I am beginning to have serious doubts about the sources of your information
Also while the patent getting approved would likely create a massive rise in PPS especially coupled with a partnership which seems to be the likely reasons we started up commercial batches,
The piece that seems to be missed here is that Elite's tech is better.
If there are so many patents out there which you somehow managed to read everyone in a few days, how come there are not tons of new abuse resistant Opioid pills out there right now?
I keep asking this question but have not seen an answer. All of these patents, yet where are the products? It is a multi billion dollar market and Pfizer, Purdue, Novartis, Bayer can't seem to get any pills to market?
The reason seems to me that Elite's tech actually managed to sequester the Naltrexone 100%
Really? Who knows that? I haven't seen it written here.
Seems most of the facts presented have not been facts actually
Like the 3 years is a long time for a patent fact
Actually avg is 3.5-4.5 years. Here look, an actual link.
http://www.iphandbook.org/handbook/ch10/p09/
Can you provide any of the links requested so far?
Can you provide those patent #s?
I asked for your impression of the Oshlack patent in light of Kibbe and Wright. Do you have a response, maybe I missed it?
I realize that reading thousands and thousands of technical, medical, scientific pages in a few days is quite an amazing feat, but I was figuring the key point to Elite getting the patent would be important to spend special attention to.
Here is the key information
"The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979) (Claims directed to mixtures of an herbicide known as "FENAC" with a diphenyl ether herbicide in certain relative proportions were rejected as prima facie obvious. Applicant presented evidence alleging unexpected results testing three species of diphenyl ether herbicides over limited relative proportion ranges.
The court held that the limited number of species exemplified did not provide an adequate basis for concluding that similar results would be obtained for the other diphenyl ether herbicides within the scope of the generic claims. Claims 6-8 recited a FENAC:diphenyl ether ratio of 1:1 to 4:1 for the three specific ethers tested. For two of the claimed ethers, unexpected results were demonstrated over a ratio of 16:1 to 2:1, and the effectiveness increased as the ratio approached the untested region of the claimed range. The court held these tests were commensurate in scope with the claims and supported the nonobviousness thereof.
However, for a third ether, data was only provided over the range of 1:1 to 2:1 where the effectiveness decreased to the "expected level" as it approached the untested region. This evidence was not sufficient to overcome the obviousness rejection.); "
So basically what this is saying and is the basis of Elite's claim of unobviousness is that while RS30 and NE30 behave the same over a certain range a person ordinary in the art would not expect the results that occurred in a more narrower range or beyond that range if you will just like the ratios noted above in the example.
As the ratio of polymer by weight is increased beyond a certain point, they begin to act much differently. And this is proved by the narrow range as tested and defined as 30%-50% of weight. The changes start at 30% and the Naltrexone is completely shut off at 50%
"The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof."
Draw a line graph and the x axis going left to right is increase of polymer. The Y axis is permeability. The RS30 goes in a somewhat linear fashion Add more polymer get a somewhat predictable increase in permeability (ie sequesters the Naltrexone longer)
Then draw the NE30 line looking very similar to the RS30. However, once you hit a certain level of coating by weight of the pill, the NE30 begins to rise much more rapidly than the RS30.
At the point the NE30 is shutting down 100% of the Naltrexone, the RS30 is still leaking Naltrexone at 60 hours, That is just 2.5 days. You can't have this stuff leaking out in your body for many days. It is much more effective and results would not be known by one ordinary on the art.
So the argument is a very strong one which says that one in ordinary skill would be able to determine a trend. Note the two lines acting the same way for the first 24 hours.
"ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof"
However, because that trend is broken and the results become unexpected which the USPTO agrees with
"The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range"
I understand if you don't have them. It is really basic information though. Just patent #s. I have been trying to help you with your DD. I can't read thousands of pages of complicated legal and scientific information in a few days like you can.
That is why Oshlack is so fascinating in light of Kibbe and Wright. I would hate to speak out of turn in front of someone who has read thousands and thousand of pages, digested diagrams, charts, scientific papers. Your opinion would be interesting to hear.
You have that conference call link? You mentioned just starting to do your due diligence a few days ago and having listened to that conference call from a few months ago. It would be great help
You said you reviewed all the patents on the subject. Like you noted, there are many patents. That would be thousands and thousands of pages in a few days reading. What are your thoughts on Oshlack in light of Kibee and Wright?
Also can you provide all the patent #s for Elite's abuse resistant tech.
You mentioned having read thousands and thousands of pages of patents for every similar patent to elites over the past few days when you started your DD on this company and then incorrectly noted that Elite didn't have any patents. Maybe I can help you find the patents you missed?
See the link would be great because you can hear the tone and excitement in their voices as well as the discussion over the Eli 216 situation which of course relates to those patents. It was a few months ago so it would be nice to listen again.
Maybe if you presented that link for the conference call you listened to that included this discussion quoted below we could hear what they said as well as the excitement I mentioned earlier
Can you provide that link?
I think you missed some of this
Here is a quick example of why I say those "facts" listed below are wrong. I am not sure what conference call you listened to but the transcript is out there for all to read
For example, you note
"The argument has been made that they are already producing commercial batched of 216, but the FACT is that they have begun scaleup."
Seems they have completed scale and and produced a commercial batch.
From the CC
"Chris Dick - Elite Pharmaceuticals, Inc. - President, COO
I think we've said before when these things have come up, we try to give out key milestones.We don't want to say too much
about anything in our pipeline particularly, we do view these as terribly valuable. So, we don't say a lot about it on purpose.
What we said this time is, I think we have reached a milestone which is scaling of product up.We've done our first batch on a
the full scale that for this product and that's a milestone, but beyond that I think there's not much that we want to say about it
now until we have something more substantial or a key milestone, again, to talk about.:"
"Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman of the Board, CEO
Well, remember, the fact that you manufactured a commercial-scale batch, that's nice, but after you do that, you have to analyze
it to make sure that it has the least characteristics that you want. Usually it takes a few tries before you get there. But, there's
no question we're moving the right direction. As you remember from the history of the Company, the scaling up of ELI-216 was
always (technical difficulty) in the development of the product.We think we have the right people now doing this who know
what they're doing.
Our CSO, Dr. Ashok Nigalaye, is an expert in controlled release, he knows what he's doing. So, we're confident that we're going
to get there and that's a big milestone for us, because if a product that you can make on the bench top is - it's almost like an
academic project, it doesn't mean a whole lot.You have to make it commercial quantities."
Here is a quick example of why I say those "facts" listed below are wrong. I am not sure what conference call you listened to but the transcript is out there for all to read
For example, you note
"The argument has been made that they are already producing commercial batched of 216, but the FACT is that they have begun scaleup."
Seems they have completed scale and and produced a commercial batch.
From the CC
"Chris Dick - Elite Pharmaceuticals, Inc. - President, COO
I think we've said before when these things have come up, we try to give out key milestones.We don't want to say too much
about anything in our pipeline particularly, we do view these as terribly valuable. So, we don't say a lot about it on purpose.
What we said this time is, I think we have reached a milestone which is scaling of product up.We've done our first batch on a
the full scale that for this product and that's a milestone, but beyond that I think there's not much that we want to say about it
now until we have something more substantial or a key milestone, again, to talk about.:"
"Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman of the Board, CEO
Well, remember, the fact that you manufactured a commercial-scale batch, that's nice, but after you do that, you have to analyze
it to make sure that it has the least characteristics that you want. Usually it takes a few tries before you get there. But, there's
no question we're moving the right direction. As you remember from the history of the Company, the scaling up of ELI-216 was
always (technical difficulty) in the development of the product.We think we have the right people now doing this who know
what they're doing.
Our CSO, Dr. Ashok Nigalaye, is an expert in controlled release, he knows what he's doing. So, we're confident that we're going
to get there and that's a big milestone for us, because if a product that you can make on the bench top is - it's almost like an
academic project, it doesn't mean a whole lot.You have to make it commercial quantities."
What conference call did you listen to?
Your facts are wrong. Not worth further discussion I guess
Did you ever find that link for the conference call froma couple months ago you referenced having listened too a week ago?
The one where you could hear how excited Elite was about the current activities.
That is all opinion. Like I noted it would mean that every stock that every traded in the pennies does not have interest in the general investment community. Every stock that ever rose out of the pennies would prove the argument wrong.
I look at the amount of "chatter" a stock has going on as well. Here on this message board, there is point after point being made so to say there is no interest is kind of odd since here we are talking about it.
I absolutely love what this company is doing and I believe the patent for Eli 216 is a done deal
Hike,
You will like this
http://www.uspto.gov/web/offices/pac/mpep/documents/0700_716_02_d.htm
Also the company already has multiple patents in the same field and technology
How much does the general public know about ELite pharma? Its impossible to know. So any statements about the feelings of the "general investment community" are impossible to make.
Does the general investment community spend time reading patent updates about a .09 cent stock?
Major funds often won't even look at a stock unless it is on the big boards.
By using the "general investment community" as the argument, it is the same as saying that every stock that ever rose back to the big boards was a bad stock.
Even stocks like SIRI where the general public knew about them (satellite radio) blew up. And like ELTP, both were on the big boards previously.
The truth is that they can make Elite dance however they want
Epic/Actavis/Elite - They all are tied to shares backwards, sideways and forwards
Need some more products - Here buy these ANDAs, develop these drugs, Use your facilities for these drugs,
Who benefits? The same people. It is absolutely incredible.
Thanks Hike. I knew they had serious issues. I think people died as well. Just shows how valuable Elite is to have an FDA, DEA approved facility. Making opioids is a dangerous practice and not easy to accomplish.
Consider that if Actavis has Oxycodone, and Elite can make extended release versions and abuse resistant versions......
One thing I have been trying to understand and maybe you can help me with is if Purdue's patent runs out in 2013, how did Actavis get the drug. Never been able to put this together.
Maybe you missed it but I was looking for that link to the CC
".....You said you just started doing DD a few days ago, so I was pleased that you had the link to the CC. Please post the link so others can listen to it.
I am so friggin pumped over the Eli 216 news. Starting commercial batches of an 800m PH3 drug, with an SPA from the FDA. Then theparne for half news and then funding news!..! Amazing news.
And that is not even counting the 4-6 drugs pending launch?
Unbelievable what this company is about to do.
Did you read the patent updates from 12/8? I think we now know why we have started thosecommercial batches."
None of the below info makes any sense and has been dis-proven over and over again.
"much of this has been effectively dealt with previously but a few comments are in order. There is no evidence of stock price manipulation. This is a frequent cry from desperate investors in penny stocks, but there is little evidence to it is widespread, and I have seen no credible evidence that it has occurred here. Usually when pennies ARE manipulated, it is Pump and Dump, that is something to think about. As for product launches, we'll just have to wait and see.
As for the abuse patent, I think we have effectively put that issue to rest, they may get a patent, but there already are oxy/nalexone patents so it is bit of a non-event for most investors.I also have dealt with the fairly constant error of calling these commercial batches, they have begun scaleup, that is very different from actually making batches for sale.
Bottom line, it is good to have enthusiastic posters, but cold hard facts are better any day than statements of belief. "
Something I found that is extremely interesting
So Actavis is Mikah.
Elite has a deal with Actavis to do contract manufacturing. Actavis is marketing these drugs.
The president of Mikah is Nasrat Hakim
Nasrat Hamik is VP at Actavis too and owns shares
Nasrat is/was special consultant to the CEO of Epic who financed Elite through their strategic agreement and own convertible preferred shares, warrants milestones
Epics president is also Elite's Chief scientific officer developing the very same Eli 216 abuse resistant Oxy, with an SPA from the FDA, commercial batches just started, patent close based on recent arguments.
"Mikah Pharma has contracted Elite Pharmaceuticals to develop and manufacture our top leading products." MIK001 being the likely first as noted by Elite
http://www.mikahpharma.com/index_files/pProducts.htm
Not bad for a company with a ~23m market cap.
The folks with the most to gain by a massive rise in PPS are the ones in control of Elite's product development, acquisition of new products, etc
Want more? Many of the products Elite is getting were originally from what I believe is now closed. Actavis Totowa facility
Follow the money
stocks go up and stocks go down and easy to manipulate on low volume
Fundamentals only getting better with the funding deal and really explains a lot in terms of what appears to be going on
http://www.smallcapnetwork.com/A-Little-Funding-Goes-a-Long-Way-in-Relieving-Anxiety-OTC-ELTP/s/via/14/article/view/p/mid/1/id/469/
Here is what I see 1st quarter timeframe
Methadone - I really believed we would see this launch by the end of the year but it didn't. We know they are working on it so it is any day now. Hopefully this upcoming week.
Hydromorphone and Naltrexone - FDA Pre-approval inspections completed in August I believe. That was almost 5 months ago. We should see this launch this quarter.
Additional ANDA approved and launched - Also part of the FDA pre-approval inspections in August. I really want to know what drug this is.
Lodrane 24, 24D - I am guessing 50/50 on these coming back this quarter. ECR and Hi-Tech (HITK) have been working on this since 2010. The petition in court was originally asking for a delay until 1st quarter as well for manufacturing so it would seem they saw this as the timeline for approval as an NDA
Patent news - This company has been trying to get these patents through for years. The abuse resistant patent is very very close. I encourage everyone to read the latest submission to the USPTO. Note that this came after they had a conference call with the office regarding the also close extended release patent. Elite has clearly demonstrated that the results of their tech are not only not obvious but actually contrary to the results someone in the art would expect. The patent office agrees with this and Elite has provided the evidence to support it.
The extended release patent is also close. Also note that the tech in the abuse resistant may also provide IP coverage for the extended release patent. My understanding is that Elite has to narrow the scope of the claim to either be only about Oxy where they can demonstrate with data that the results are not obvious and in fact unexpected or they remove the 40% claim since each opioid would have it's own profile
1st Epic drug will probably go out this quarter as well. The company has alluded to this fact. I also expected this to launch in 2011
Actavis drugs - We should get some news on the launch timeframe on these. Isradipine is the one to watch. 50m market with few competitors.
The most telling piece of data from the company is that they have started commercial batches of Eli 216. Based on discussions with IR as some here have confirmed there are basically 2 reasons to do this. Ramping up for PH3 or demonstrating to a partner that your tech works (no leakage of the Naltrexone)....or both
Note that Elite has an SPA from the FDA and they are likely to perform added trials to show efficacy results with food and folks with sensitive stomachs and such. The tech works.
Bottom line for me as it always has. Show me another company that has this pipeline and this massive potential and is already at PH3 pending trials for an 800m drug you know has a very likely chance to be approved as it is using existing approved medicines.
This is just 1st quarter and we could also see something on HITKs 100m intermediate or some of the other drugs in the pipeline.
It is right there in the patent info I keep telling everyone to read.
Maybe you missed it but do you have that link for the conference call a couple months ago that you just listened to. Everyone should hear it.
At 300% no naltrexone was released. Its in the patent response I keep saying is so importat for everyone to read. If you read all those thousands of pages, diagrams, studies in all those patents over the last couple days, I am not sure how you missed it.
Actually it seems to me that elite is way ahead of the game since they have proven they can sequester the Naltrexone 100% that is the point of the patent.
You have that link for the conf call from a couple months ago that you just listened to last week?
Thanks guys. The company is really on the verge imo. I have always seen it at worst a generic company that will eventually turn a nice profit, there were close until Lodrane and the CBE30, and at best a multi billion dollar pain med company. It does seem that thre are forces at work that want to see them fail but just look who has partnered with them at this point.
And anyone should really give IR a call if they have questions. Its a great place to start.
So you don't have a link?
If you feel that way great. It is quite obvious to me that your argument doesn't demonstrate anything in regards to Elite's unique tech products or competitors. Like I said if it was so easy, those billion dollar companies would be spitting them out like M&Ms to be first to market. It is a multibillion dollar oppotunity.
I am so excited about Eli 216 commercial batches I can't stand it.
You got those links? you just listened to the CC call, please send me that link first. The others tomorrow.
Thanks dude
Can you provide any of the many links I have requested? That would be great. Please start with the recent conf call and then the rest as soon as you can. I just absorb so much of this information. It is awesome and fits a huge need in society.
If just adding Naltexone to an Opioid was all it took, then there would be dozens of these products on the market. Why aren't there?
It is a massive societal issue in the news practically every day.
How many approved abuse resistant Oxycontin products are out there on the market right now? How many have been pulled?
How many on the market that use an antagonist?
Why is Elite's tech so unique? Because it succeeds where other companies have failed and that is sequestering the Naltrexone. It also is why the patent is likely to get approved. At 300%, no Naltrexone is released but you probably read that right?
It is why Purdue observed and confirmed that what Elite was doing was unique. Contact investor relations is a great way to understand what a company is up to, get up to speed. Since you have only been in this for a few days, you might find it helpful.
Link to failed abuse resistant Oxycontin? Just use Google and see how many products there are and how many are on the market and what has been pulled. and also see what companies have paid to acquire failed tech like remoxy.
You read every patent on the subject? That is thousands and thousands of pages, claims, diagrams, charts, studies and in just a few days? What is your impression of the Erkoboni declaration and the uniqueness of NE30 application as a sequestering agent? Basically proved Elites results are unexpected
Heck, Pfizer paid what 400m for a failed remoxy
Oxecta failed until they removed the niacin but has issues
Please name the products on the market that use Elite's methodology.
Not going to provide links. Just google abuse resistant Oxycontin and see what products are out there. Like I said if it was easy, these multi billion dollar companies would have it out the door.
The reality is that Elite has managed to sequester the Naltrexone through their patentable tech.
That is likely why commercial batches of Eli 216 have started. Estimated market of 800m.
That's a lot of data but let me help you out there nut mostly useless. They only have one competitor. Elite is PH3 pending. Their other competition products have failed. If it was easy, there would be dozens of these formulations out there already. It's not easy so competition has focused on bad ideas like adding niacin or a "gummy bear" type formulation. All have had issues and removed, delayed etc...
Did you read the patent info?
The whole point is that Elite formulation as been able to sequester the Naltrexone with no leakage. That is what makes them unique. That is also what makes their product and formulation "not obvious" and why the patent is likely to get approved.
Their tech is unique and works.
You should call IR so she can explain it to you. Elite used to trade in dollars before management took them down a bad path. New management, partnership with Epic, save the company.
Also I believe it was Purdue that came and observed Elites tech and also confirmed that what Elite was doing was unique.
http://www.chiroeco.com/chiropractic/news/7641/34/us%20back%20pain%20market%20approaches%20-23%20billion%20in%202018%20-%20anticipated%20long-acting-%20abuse-resistant%20opioids%20drive%20value/?skeyword=opioids
Also if you have those other links requested that would be great
I don't have the link. You said you just started doing DD a few days ago, so I was pleased that you had the link to the CC. Please post the link so others can listen to it.
I am so friggin pumped over the Eli 216 news. Starting commercial batches of an 800m PH3 drug, with an SPA from the FDA. Then theparne for half news and then funding news!..! Amazing news.
And that is not even counting the 4-6 drugs pending launch?
Unbelievable what this company is about to do.
Did you read the patent updates from 12/8? I think we now know why we have started thosecommercial batches.
I hear ya. Totally get it
I am not sure if I am allowed to say where he went. Lots of manipulation. Someone needs this stock cheap. Watch the trading its funny. If you are serious about the company, read the ppatent update on the abuse resistant ox, Elite's last response and then consider they ramped up commercial batches a couple months ago. Draw your own conclusions.
Do you have a link that shows where enthusiasm isn't shared?
I found this link here
http://www.chiroeco.com/chiropractic/news/7641/34/us%20back%20pain%20market%20approaches%20-23%20billion%20in%202018%20-%20anticipated%20long-acting-%20abuse-resistant%20opioids%20drive%20value/?skeyword=opioids
and this link too where Elite is mentioned
http://www.businesswire.com/news/home/20110412007011/en/Research-Markets-Chronic-Pain-Therapeutics-Market-Forecast