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It's $2000 ....big deal
Painkiller 10 times stronger than Vicodin worries addiction experts
http://www.cbsnews.com/8301-504763_162-57348477-10391704/painkiller-10-times-stronger-than-vicodin-worries-addiction-experts/
Cut & Pasted directly from the 11/15/2011 conference call transcript:
Elite has 3 contract manufacturing opportunities. Of these 3 contracts, we expect that for methadone, Elite will begin shipping their first batches later this quarter.
From my 12/15/2011 Q&A email with Dianne:
2) Has Elite begun making and shipping Methadone?
It was disclosed in the last quarterly conference call that Elite expects to begin shipping methadone before the end of the month. In order to do so, it would be fair to conclude that they have begun manufacturing by now.
Might be ready to roll out and unudergoing change of host and dns propagation is ongoing. Should not take more than 24 hours though if that is the case.
Of course the most common reason for a site to be suspended is lack of payment for hosting services, violation of terms of use etc.
Methadone was expected to ship before the end of this quarter.
Should we expect that Elite would release a PR on that when it happens? In other words would that be considered a "material event"?
Grabbed 10,000 @ .069. That should be all the buying for me. Comfortable with the level I am at and .0922 average.
Now just sit and wait, and wait.
Can you 'splain that to the rookies? (Me!)
Some .078's to end the week.
Average is .0934 now.
Have a great weekend everybody!
Gordon:
I am most certainly not saying that.
I think you misunderstood. I think your post was terrific and I appreciate your sharing.
I was referring to my own posts about how I wanted to explore the Euro vacation angle further. Some folks couldn't understand why I would care about that. I explained why I cared about that and jokingly stated that this is the kind of thing we talk about on the board when the company doesn't gives us PR's.
Also you can't blame anyone for wanting to verify & clarify a board post that contained excellent info. We all have to do our DD and it would not be responsible for me to just take anyone's word for anything posted on a board.
So please don't be offended. That was not my intent. Ask anyone, I try to be as mature and thorough as I can be.
Hike
I know it's a bit ridiculous but this is what happens without PR's!
There was a logical reason to look into this.
Dianne stated, according to Gordon, that the entire company/industry (not just individuals) took a month off @ Easter.
If that were true that would be fairly unique. I never heard that before.
So what if we found out that this is common say, only in Switzerland, where Actavis has its HQ? That would be another small piece of the puzzle.
As it turns out this is not common at all from what I have learned.
Either Dianne exaggerated a bit or things got lost in translation.
But I try to leave no stone un-turned!
Per my Euro friend....
I agree with you that taking as month long Easter break is not anything I’ve heard about. Many people do however take a week or so as it’s a holiday here from Green Thursday to Easter Monday.
Thanks Gordon.
I have a call into a good friend in Europe that is a high level pharma exec. I asked him about the vacation thing for some local insight. I'll let you know what I hear.
I deal with European suppliers all the time and never heard that before. I Googled it too and really came up with nothing definitive.
The next 3-4 months are going to be very interesting.
My questions and answers from Dianne:
1) Has Elite received the final go ahead yet to make Naltrexone and Hydromorphone? The CBE 30 had been holding us back.
Nothing has been announced. This would be material information and the company would be required to disclose this information within four days of such notification.
We had originally filed a CBE 30 with the FDA on the hydromorphone product. The FDA responded that they reclassified the supplement to a “prior review”. A press release was issued on June 6th.
2) Has Elite begun making and shipping Methadone?
It was disclosed in the last quarterly conference call that Elite expects to begin shipping methadone before the end of the month. In order to do so, it would be fair to conclude that they have begun manufacturing by now.
3) Is it true pharma companies in Europe take a month off at Easter?
Don’t know. I do know Europeans take many more holidays than they do in the United States.
3) Is Elite about to begin human testing of ELI-216?
The last information that was disclosed is that Elite plans to secure a marketing partner before beginning the final clinical trials.
The scale up of ELI-216 certainly will help in securing a partner.
Emails from Dianne below. Obviously she is being a bit careful as she should.
I don't have reason to doubt Gordon at all. My feeling is that Dianne is likely to be much more open during a phone call than via email/in writing.
Much of this info was largely known already however we got more detail thanks to Gordon. The biggest piece of "new" info, which I wanted clarification on are the statements regarding upcoming testing on humans of ELI-216 and the more or less confirmation that the ELI-216 patent is nearing final approval. I'd also like to find out what countries take a month off during Easter! I knew it was common to take August off in Europe but not April. So I sent her a followup email with a couple of specific questions. I'll post that next.
–
I really hate these message boards.
Not exactly what I said.
The company said in the conference call that they were doing scale up.
I discussed the importance of scale up.
I also discussed removing risk and the steps before entering the Phase III which are all steps designed to remove as much risk as possible.
Showing that the company can produce commercial scale batches would be important to a potential partner.
I think it would be easier if I were to answer specific questions that you have rather than commenting on information posted by 3rd parties.
Agree, hence my reaching out to Dianne.
No word yet.
Just FYI.
I took what I copied and pasted on Yahoo and emailed it to Dianne for verification last night. Hopefully she will confirm.
From Yahoo Board...
Nice call with IR Dianne today and updated info 14-Dec-11 05:16 pm
I spoke on the phone with IR today and got some great news to share. The scale up of ELI 216 which we have been calling batch testing is to demonstrate to a "potential" partner that Elite can make commercial batches of the product consistently. They look for inconsistencies or leakage down to picograms which is even smaller then nano grams to demonstrate to the partner that they can put out a consistent good product. All is going very well with this test and they will begin some testing with actual patients very soon with the drug technology.
FDA came through for final approval on 4 drugs. Methadone, hydro morphine, the ANDA and Naltrexone. They are expecting to get methadone launched before the end of the year and the 3 others in rapid succession as FDA will most likely approve all 4 at the same time.
Patent for 216 is still right on track and looking better and better each day for final approval. Only one other pharma company (Pfizer) uses similar technology but it is still slightly different and not as effect and efficient as Elites version.
154 is still very popular in Europe and they are still negotiating a way to phase 3 that product. She said a big multi nation pharma company has shown interest as well over there.
She could not say why the PPS drop today but typically she said you do see that in December with persons taking their losses for the year and maybe a sell off and tax reasons involved.
She is very confident that things are going to start happening in rapid succession and they will utilize their secondary facility to full potential when the pipeline really begins to flow. She told me that is looking much sooner now then later. ECR still working on 24 hour Lodrane also and that looks positive as well for returning to the market.
This is all that I have from memory to pass on at this time
Got my buy in for the AM...15,000 @ .081
Just a little Xmas bonus...
Damn this is sooooo overdue.
Methadone = .10
Naltrex = .12
Hydro = .14
Lodrane 24 = .22
ELI 216 patent = .50 and beyond
I agree. You went into much more detail but we are essentially understanding this the same way.
In a nutshell, the Patent office felt that the coating we used was comparable to other coatings and that the rate of release of the agonist (oxy) was comparable and therefore it was "obvious" what would happen and therefore not patent-able. Our attorney provided strong evidence that, as the coated level is increased, our coating behaves much differently (releases much less) and that therefore it would not be obvious at all to assume that one coating would act the same as another.
I am not a patent attorney and perhaps I over-simplified the explanation. I would welcome other folks take on it.
Patent Update
12/478,952 ABUSE-RESISTANT ORAL DOSAGE FORMS AND METHOD OF USE THEREOF
12-08-2011 A... Amendment/Req. Reconsideration-After Non-Final Reject PROSECUTION 1
12-08-2011 CLM Claims PROSECUTION 4
12-08-2011 REM Applicant Arguments/Remarks Made in an Amendment PROSECUTION 4
12-08-2011 N417 EFS Acknowledgment Receipt PROSECUTION 2
12-08-2011 TRAN.LET Transmittal Letter PROSECUTION 2
Can't tell, I don't have level 2....just looked at the Trades as posted on Ihub w/ 15 min delay
Sorry, I meant once it opens..
Can someone do a L2 shot?
Thanks in Advance.
.0869
The bid was .0905
The ask was .0920
What is a "fake wall"?
Are you saying there is an order to sell 1,000,000 @ .045 that isn't a "real" order?
All clinical trials in the U.S. must be approved by an IRB (Institutional Review Board) before they begin so if commercial batches are considered part of the Phase 3 trial (not sure of that) then I imagine they would need the FDA's OK.
Also, for cgmp there is a LOT of reporting (mostly statistical reports on manufacturing/variations etc) that are done and I believe that that QC process etc has to be thoroughly documented and approved before physical batches are made etc.
Whether that level of data is available to the consumer/investor I don't know.
I'll keep poking around on that.
On overstock it says:
This item is out of stock.
Please enter your email address, and we will notify you if it comes back in stock.
Pain Management Stocks: Will This Painful Downturn End Soon?
http://seekingalpha.com/article/311365-pain-management-stocks-will-this-painful-downturn-end-soon?source=yahoo
1 comment | December 1, 2011
Pain management companies haven’t had their best month, with shares trading down approximately 24% on average. In fact, the second was the second worst performing in the market after Chinese solar companies. But has this sell-off created an opportunity for investors or will these companies continue to feel the pain?
Pain management companies on our radar include:
Acura Pharmaceuticals Inc. (ACUR)
Cumberland Pharmaceuticals Inc. (CPIX)
DURECT Corporation (DRRX)
Endo Pharmaceuticals Inc. (ENDP)
Horizon Pharma Inc. (HZNP)
Pacira Pharmaceuticals Inc. (PCRX)
Pain Therapeutics Inc. (PTIE)
Zogenix Inc. (ZGNX)
Competition Intensifies with Patent Expirations
The pain management industry is likely to face significant headwinds with the upcoming expiration of anticonvulsant Lyrica and antidepressant Cymbalta. Meanwhile, generic pharmaceutical companies like Teva Pharmaceuticals Inc. (TEVA) are developing drugs like Fentora (fentanyl), while many others are coming on the market increasing competition.
Generics may also limit the market potential of even very efficacious drugs as patients try and weigh the costs against the benefits. With the strong efficacy seen in many soon-to-be-generics, patients may feel little need to spend the extra money on prescription drugs. As a result, many of these companies may face an uphill battle even if their pipelines materialize.
Low Valuation May Spur Industry Consolidation
The M&A market may be showing new signs of life, while the big pharma industry faces its own set of patent expirations. Companies looking to bolster their pipeline for cheap may be looking at the pain management industry, where stocks trade with a price-earnings ratio of just 12.3x compared to the 20x S&P 500 average.
In particular, many big pharmas may be now focusing on formulation and delivery technologies, according to Lux Research. Many pain companies are focused on this same niche as a way to differentiate themselves from already-efficacious generics on or hitting the market. As a result, this may further boost the argument for acquisitions in this sector.
The Takeaway …
The pain management industry is one of the lowest performing industries over the past month, dropping some 24% on average.
The primary reason for this decline is likely increased competition from generics and a rough overall market.
Despite this drop (or indeed because of it), riskier investors may want to take a look at some undervalued plays focused on formulation and delivery.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Me too....let's just call it a communication breakdown!
Dussault Sunglasses
By Dussault Apparel (Albums) · Updated about 2 months ago
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13 people like this.
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September 24 at 10:08am · Like · 1
Michael Dussault Holy shit those look amazing! How much and where do I get them?
September 24 at 6:42pm · Like
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September 24 at 7:44pm · Like
Lisa Pilagonia I like them, i want a pair.
September 24 at 8:13pm · Like
Jåmes JB I like them too, the face in the end of the arms was a nice touch
September 24 at 9:41pm · Like
Loren Bacall cool glasses, where can i buy them?
September 25 at 6:37am · Like
Dussault Apparel They will be available Jan 2011
September 25 at 11:59am · Like
Loren Bacall you mean 2012?
September 25 at 12:10pm · Like
Dussault Apparel Yes sorry 2012
September 26 at 10:37am · Like
Ralph E. Shaffer DUSS invest all you can afford. prosperity and success brings hapiness.
October 11 at 2:19pm · Like
Dan Wicklund whats with the rumor of sunglasses line being released next week??? enlighten me...
October 22 at 5:18pm · Like
Last I checked it's still Fall 2011
I'll just look at that as an opportunity to buy more. However methinks there will be a methadone announcement soon that should help hold the stock price up even in the face of tax selling.
I know more about quantum mechanics than I do about charts....but those bands are mighty close to each other? Is that a good thing?
Link to transcript of last conference call.
Yes, I plopped down another $100.
https://docs.google.com/open?id=0BwI9WYgqHk9mMWM3OGM4MmUtY2I4Yi00MDliLTkyMmUtNGZmYzhjMTVhOWMx
It's painful to sift through postings there but there are certainly some folks that go the extra mile.
From Yahoo board:
was talking to Dianne 30-Nov-11 11:42 am
about what the FDA approved and the launch date. The FDA changed there rules they are working with them looks good. talked to her about the manager of operations.The person they have worked with other companys they want someone to work just for them thats good. I talked to her about ELI154 looking for partner but she was very excited about ELI216 looks very good.I told her about it would be nice for the Investers to have something before christmas she said there will be something before the end of the year. could be 2 products. Time to get on the boat before it leaves the dock.