pagiantmetknicksfan@yahoo.com
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its funny. Bids at .085 most of the day, they run it up first thing in the AM. And then drop30k on the ask at .083 to hold the price down. Not sure what the whole motivation is except accumulation. We already know the products in the future.
Yes and I am trying to not over reach but I think we get the extended release too based on this but that is more complicated.
Regarding extended release, it seems Elite needs to show their findings in detail and in a more narrow scope. ie Oxy and not all opioid.....At least that's my understanding. It is clear to me that they have the data to do this based on today's response for abuse resistance.
correction - ability to sequester the Natrexone or Opiod antagonist
huh? This is in response to the previous non final rejection in september timeframe I believe.
This is great news. They basically say to the patent office if we combine the art like you say would be obvious you get expected results until you reach a threshold whereby the results become completely unexpected and make Elites ability to sequester the opiate unique and completely effective.
Elite still won't even concede that combining the art is obvious and is showing data that the results would be unexpected.
Just got done reviewing it. Need to compare it to the previous data looking for differences in the claims but what Elite is saying is obvious, no pun intended. If you have read the info you get the joke.
The patent office has narrowed their arguments against the claims to being about basically three previous findings and that it would be obvious to someone in the art to combine these ideas to get the result Elite is claiming.
Elites argument which is extremely strong in my opinion is that not only is it not obvious but actually contradictory to the results you would expect to see from the prior art.
A similar argument is also now being used in the extended release of opiates.
Let me try and simplify this and hopefully I have it right. I can't copy and paste for some reason but will try later.
Basically the patent office said previously that while it is not obvious to use sequestering product "a", you would use the method A with product "b" which would be obvious to someone in the art to combine these ideas. Elite has actually proven with data that if you did this, the results are unexpected based on that combination.
Elites method has shown unique and unexpected results once you increase the coatings beyond a certain threshold with the "B". Thus it is new art.
They show that if you do what the Patent office says would be obvious you get a different result then you should based on that assumption once you go beyond a certain level. Thus not only is not obvious, but it is actually a different result then you would expect.
Going to try and copy paste some of the info in a bit.
All manipulation. Get used to it for now. won't be forever
Looking at the trades.
What is the deal with the big # of other trade volume?
My fingers are crossed for an eli 216 patent announcement. For us to start commercial batches, either we are proving to a partner that we can do it or going to PH3 or both. Patent would probably be key to either.
Much appreciated Hike
Nope but I smacked 85 too
still hasn't filled
I have a bid in for 10k at .0835. I was th first bid t .0835. We have hit .0835 several times and no shares filled. These are probably shorted. Last one was for 1000 shares. Who would short 1000 shares?
I think we are just at the beginning. This thing is much bigger then a few drug launches imo.
I think so too.
The longer the wait, them more things stack up. Reach a point of critical mass. Some other PRs to look for are a new website, new deals with Mikah, HITKs 100m intermediate, Lodrane news.
So many things going on it is just silly
Believe me or not. I just said to myself I bet Epic has been filling these roles for them but now there are too many things going on...
That would be definitive
Yeah. This is where I get confused. It says this in a few places.
Thanks. I will make an update later to my sheet. They make oxycodone too which is percocet. If you google oxycontin and actavis you get some misleading info. You are right that oxy patent is through 2013 so I should have looked into it more. Either way, there is a ton of $$$ in these drugs
Product List
Thought I would post this here as well
Lodrane D This is the new Lodrane. Per the conference call this is selling better then original Lodrane formulations in the same timeframe. Elite was operationally profitable from the original Lodrane products below.
Lodrane Once a Day Original Lodrane Products. Elite has been working with HITK since mid 2010 range to secure NDA with FDA. Active ingrediants have been on the market for decades
Lodrane 24D Original Lodrane Products. Elite has been working with HITK since mid 2010 range to secure NDA with FDA. Active ingrediants have been on the market for decades
Phentermine Top Diet drug. Sales are progressing well since Launch per the Conference call
Methadone Contract Manufacturing with The Pharma Network/Ascend labs. Based on 2006 numbers, this is a 60m - 100m drug.
Hydromorphone FDA approved but pending CBE 30. Also known as Dilaudid. Pre Approval inspection completed in August. Hydromorphone and Naltrexone are combined 120m drug http://www.healthcarepackaging.com/archives/2010/09/elite_pharmaceuticals_announce.php
Naltrexone FDA approved but pending CBE 30. Pre Approval inspection completed in August. Also a key ingrediant in Eli 216. Hydromorphone and Naltrexone are combined 120m drug http://www.healthcarepackaging.com/archives/2010/09/elite_pharmaceuticals_announce.php
Undisclosed ANDA Also pre-Approval inspection completed in mid August. Can't hardly wait to hear what this is but I am guessing another pain med since that is Elites specialty
HITK ANDA #3 http://www.healthcarepackaging.com/archives/2010/09/elite_pharmaceuticals_announce.php
HITK ANDA #4 http://www.healthcarepackaging.com/archives/2010/09/elite_pharmaceuticals_announce.php
Eli 154 24 hour Oxy. Massive revenue. If you know anything about pain meds, you know how big this is. Measured in hundreds of millions. We have a partner willing to fund only half due to internal policies. Listen to the cc. Patents have reached discussion level with the patent office. Read up for yourself. Branded Product.
Eli 216 Abuse resistant Oxy. Even bigger then 154. Commercial batches started per the conf call. Commercial batches are a pre-req to approval, PH3 trials. It shows that Elite is able to produce the drug on a commercial basis and keep all the same properties. Again measured in hundreds of millions. Branded products
HITK Intermediate for 100m generic Pending HITK ANDA approval I believe. http://www.globenewswire.com/newsroom/news.html?d=210753
8 Epic drugs from agreement Elite get 15% of profit from each drug in return for milestone shares, and maybe warrants. Epic is half of Elites BOD and closely tied to Actavis/Mikah. Epic already uses Elites facility to make some drugs.
ANDA From Epic Trying to find more data on this
MIK001 classified R&D project with Mikah/Actavis. Listen to the CC. Speculation is utilizing Elites unique technology to formulate hard to make extended release drugs. Actavis has generic Oxycontin.
Isradipine 2.5mg Contract manufacturing with Actavis/Mikah. Isradipine is a 50m drug with few manufacturers. Maybe have been part of a monopoly issue with Actavis. Again tells you how few manufacturers there are.
Isradipine 5mg Contract manufacturing with Actavis/Mikah. Isradipine is a 50m drug with few manufacturers. Maybe have been part of a monopoly issue with Actavis. Again tells you how few manufacturers there are.
Phendimetrazine Tartrate 35 mg another contract manufacturing drug with Mikah/Actavis
Anti-infective ANDA From Elite website
Gastrointestinal ANDA From Elite website
7 mostly pain meds from Mikah Website http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_E/threadview?m=te&bn=99215&tid=107922&mid=107922&tof=16&frt=1#107922
Didn't the product have a controlled release in the middle of September? How can you recognize revenue in that timeframe? We do not know the terms of their acceptance agreements, and then shipping to Germany too? Cmon Man.
The comment below about not even 1000 dollars is very astute.
Inventories however went from 0-200k with 44k coming finished goods and the rest unfinished. Looks like they had just started completing filters in that timeframe.
Half the volume is short volume to hold the price down.
Its one of the reasons I am so bullish. Also pain meds are a huge market
Remember this article
http://www.businesswire.com/news/home/20110412007011/en/Research-Markets-Chronic-Pain-Therapeutics-Market-Forecast
Look at the drugs in Mikahs pipeline. I suspect we will be making those for Actavis. It basically says so on their site.
26 plus 21 = 47
10k is about what I expected. We are a bit off of last year but no 24 hour Lodrane. Just need to get the other products launched.
just go through the PRs from their website for yourself
http://www.elitepharma.com/investor_relations.asp?limit=10. go back a full year and start there
I'm not expecting a lot really. Doesn't need to be a lot either. We are at the bottom of this escalator.
We were operationally profitable at what 4m a year?
Anything we get this Q is a bonus in my opinion.
Would love to see the 4 drugs from the pre approval inspections come out. So curious as to what they were. I highly suspect it is Hydromorphone and Naltrexone but the other two....no idea.
One is a new unnamed ANDA
Revenue
Phentermine sales
New Lodrane revenue for manufacture, development, packaging
Remaining Lodrane revenue
Methadone revenue for development, manufacture, packaging?
Revenue from Epic for the 8 Epic drugs???? Still haven't heard where we are on these yet
about 20-30 more to go
Reposting about shares
"Cui Bono" Who benefits - connect the dots
I wrote about this back in April during the strategic alliance which basically removed any threat of bankruptcy.
Remember most of these shares in the increase in authorized is already spoken for by Epic. Warrants and Milestone shares.
So here is the kicker. While this would likely never happen except right before a merger, what would happen if Epic decided to convert and sell all those shares?They would drive the price below what they paid for them in the first place. Here is where “Cui Bono” becomes relevant
Epic owns half the board of directors and Epic execs are large shareholders themselves. Now, here is the simple part. If you were a board member with millions of shares, could pump as much money and products into Elite as you wanted to (We have seen this already with the 8 drugs, strategic alliance etc), what would your strategy be?
To make as much money as possible. Elite has 30 drugs in their pipeline right now that will be made at Elites facility. Elite just doubled their capacity. See the 8k where it is reconfirmed. Folks got a tour during the meeting and I am mad at myself for not going.
How many drugs does Epic have commercially? Per their website they have 10
Ok, how about the Pharma network? 15 per their website which is Ascend
Ok, how about HITK? They have 90 but many are various forms of the same drug. They have about 20-30 actual drugs and a 400m market cap and are one of the fastest growing pharma companies per Forbes.
Actavis is of course one of the largest generic companies in the world.
Mikahs R&D is going to be made by Elite. It’s on their website.
These are Elites partners
What does Elite have that most of these companies don’t have? A DEA, FDA GMP facility. They make controlled substances and many are everyday common drugs, Phentermine a top diet drug, Hydromorphone which is Dilaudid, Methadone, Oxycontin, Lodrane,etc..
And Mikahs products???? Percocet, Percodin etc. Check out the website. These are massive generic drugs.
And who is Mikah? Designee of Actavis and consultant to the CEO of Epic.
And I haven’t even mentioned the patents for unique and extremely valuable time release and abuse resistant drugs worth 100s of millions and really billions. BTW, Actavis makes Oxycontin too.
“Cui Bono” Who benefits? The folks that own the stock, Epic, Mikah (owns a bunch), Elite of course.
Today's 8k was all about the above items. Things take time but with 30 products to be made at Elite that we currently know about, this is just a matter of time in my opinion.
I agree. I asked the vey question on the last cc.
It doesn't prevent them from making the drug in the long term but it does take away their right to be the only other maker. In other words, someone else could use their IP to make the drugs. Actavis has oxy so I wonder if that is the fail safe here.
I think they are just waiting on the approvals at this point.
Its shorted about 40% daily to hold the price down. Not sure if today was someone dumped a couple hunded thousand shares or someone washtrading and forcing the price down. Didn't last but about 10 minutes at most and I picked up some more.
I seriously suspect we will see 4 FDA approvals at once. We'll see
Stocks move up and stocks move down. Low volume a few sellers cleared. 5 drugs about to launch. Methadone and pre-approval inspections complete on 4. One will be a new ANDA.
Then it will go back up.
"Cui Bono" Who benefits - connect the dots
I wrote about this back in April during the strategic alliance which basically removed any threat of bankruptcy.
Remember most of these shares in the increase in authorized is already spoken for by Epic. Warrants and Milestone shares.
So here is the kicker. While this would likely never happen except right before a merger, what would happen if Epic decided to convert and sell all those shares?They would drive the price below what they paid for them in the first place. Here is where “Cui Bono” becomes relevant
Epic owns half the board of directors and Epic execs are large shareholders themselves. Now, here is the simple part. If you were a board member with millions of shares, could pump as much money and products into Elite as you wanted to (We have seen this already with the 8 drugs, strategic alliance etc), what would your strategy be?
To make as much money as possible. Elite has 30 drugs in their pipeline right now that will be made at Elites facility. Elite just doubled their capacity. See the 8k where it is reconfirmed. Folks got a tour during the meeting and I am mad at myself for not going.
How many drugs does Epic have commercially? Per their website they have 10
Ok, how about the Pharma network? 15 per their website which is Ascend
Ok, how about HITK? They have 90 but many are various forms of the same drug. They have about 20-30 actual drugs and a 400m market cap and are one of the fastest growing pharma companies per Forbes.
Actavis is of course one of the largest generic companies in the world.
Mikahs R&D is going to be made by Elite. It’s on their website.
These are Elites partners
What does Elite have that most of these companies don’t have? A DEA, FDA GMP facility. They make controlled substances and many are everyday common drugs, Phentermine a top diet drug, Hydromorphone which is Dilaudid, Methadone, Oxycontin, Lodrane,etc..
And Mikahs products???? Percocet, Percodin etc. Check out the website. These are massive generic drugs.
And who is Mikah? Designee of Actavis and consultant to the CEO of Epic.
And I haven’t even mentioned the patents for unique and extremely valuable time release and abuse resistant drugs worth 100s of millions and really billions. BTW, Actavis makes Oxycontin too.
“Cui Bono” Who benefits? The folks that own the stock, Epic, Mikah (owns a bunch), Elite of course.
Today's 8k was all about the above items. Things take time but with 30 products to be made at Elite that we currently know about, this is just a matter of time in my opinion.
This is for warrants and milestones which means more money. Nice try ohhh joy.
These were already accounted for
The last week or so has looked like short coverng to me. Big bids, movingup and down. Trying to scare people etc. Seems pretty thin through .10 to me
If you have been following the trading on this, you would think the drop this AM was complete manipulation and if you watched todays trading too, you would be sure
You guys really believe someone took a 13% haircut because they ere in a rush to move on? On 500k shares? MMs just screwing with you.