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N2K, I HATE the idea of merger with Epic.
Such a merger would provide the easiest means of screwing ELTP shareholders. Your posts this week on valuation have been very enlightening, and they cause me to recall this:
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74676&GoTopage=2&Category=2163&BzID=2258&t=1948&G=939
Elite monetized its minority ownership interest in Novel Laboratories this quarter, receiving $5 million and recognizing a related gain of $1.7 million.
A working man sold $20,000 worth of stock.
Doug Plassche-VP-of-Operations-Dumped-over-Half-his-stock? WTH?....
Form 4 today. John P. Barratt converted warrants.
http://archive.fast-edgar.com//20150427/ATZZO22C2222C2U222232CZ2BAR5Z2278C72/
5,874,162 shares at a strike price .001. (That is $5874.16!) This follows the 8-K filing last month announcing his resignation from BOD "for medical reasons," effective April 30, 2015.
http://archive.fast-edgar.com//20150407/A6ZFW22C2222H2S2222M2CZ29A5LZ2278272/
Assuming the Restrictive Legend is immediately removed (http://www.sec.gov/answers/restric.htm), and assuming GNBT remains a "going concern" in 6 months (or 1 year), and assuming the PPS remains in range of .02, then these shares can be sold on open market for $117,483.24 (not a bad return for $5874 investment). Of course, we'll never know when he sells, since he's no longer on BOD with duty to report.
And these shares are just a drop in the bucket for Mr. Barratt:
http://www.sec.gov/cgi-bin/browse-edgar?CIK=0001270529&action=getcompany
So good health to Mr. Barrat, and good luck to all longs!
There was no dilution yesterday re: Form 4's
I think it is important for everyone to realize that there was no dilution yesterday
How would we know that???
cicle1, I think it is what it is
IYO is this a good or bad thing..tia
Breakdown of yesterday's Form 4's:
13,760,695 (NH)
2,700,000 (")
2,570,018 (")
12,850,089 (NJ)
19,275,133 (AN)
--------------
51,155,935 (Insider Total)
67,659,232 - 51,155,935 = 16,503,297 - 51,155,935 = 16,503,297 (Non-insider total)
Total shares remaining under Epic Investments = Zero
Of the 67,659,232 shares distributed, insiders with reporting obligations received 51,155,935 shares. These shares are not restricted and they may sell those shares at any time but not without SEC filing. The remaining 16,503,297 shares went to non-insiders who may sell those shares at any time without notification. (I suspect Ram Potti receives most if not all of those shares). These shares are all previously accounted for and do not represent dilution or conversion of warrants. No shares were bought or sold. Epic Investments has no remaining shares.
If I am reading these incorrectly, somebody with more expertise in this area please correct.
hotelbar, I'll believe it when I see it
Has anyone seen the news from smfi. Looks like the crooks at gnbt will be putting a few more dollars in there pockets
"We are excited about our new initiatives which includes The Tamarack Project and our recently announced non-binding LOI with Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) to license the Generex proprietary RapidMist™ drug delivery technologies," continued Mr. Donahue. "Our goal is to promptly execute on our business model over the coming weeks and months while illustrating a clear pathway to strong fundamentals for our shareholders."
Further due diligence from both parties need to be completed prior to a definitive agreement being signed. Final terms and conditions may vary.
The research sites are definitely recruiting.
The issue I have is the impression that the study may be open for enrollment but that does not mean they are actually doing it
HER2-Specific Vaccines for HER2-Positive Breast Cancer Immunotherapy
World Journal of Vaccines, 2015, 5, 106-128
Received 19 March 2015; accepted 18 April 2015; published 24 April 2015
4.9. HER2 Hybrid AE37 (AA: 776-790) Peptide Vaccine
Given the limitations associated with the HER2 peptide vaccines discussed above including waning of immunity with progressive decrease in specific CD8+ T cells, there is a need for booster inoculations to sustain an effective peptide-specific immune response [88]. While the GP2 (GP2 + GM-CSF) vaccines stimulate CD8+ T cells which effectively elicit cytolytic activity directed against HER2-expressing tumors, concern exists that a durable vaccine-specific immune response may require the use of a CD4+ helper T cell epitope to establish a long-term memory CTL response. This has led to the strategy of immunization with a vaccine capable of primarily stimulating CD4+ helper T cells, such as the AE37 vaccine. The AE37 HER2 peptide vaccine is an MHC class II epitopes which is embedded to the MHC class me epitopes with the hope that vaccination will stimulate both CD4+ and CD8+ T cell responses [88]. It is known that using longer peptides as MHC class II epitopes can function as a polyepitope vaccine with both CD4+ and CD8+ T cell epitopes present, this combination therefore could allow for more efficient immunization [88]. Consequently, a modification of the hybrid peptide vaccine has been reported [88] [89]. This involves amplifying the activity of MHC class II epitopes and linking it to a four-amino acid moiety (LRMK; Ii-Key) to the N-terminal end of the epitope peptide either directly or by using a simple polyethylene spacer (-ava-) to produce the li-key HER2 peptide vaccine otherwise known as the AE37 [89]. Ii- Key is derived from the MHC class II-associated invariant chain (Ii protein). It catalyzes binding of the linked epitope to the MHC class II molecule, thereby enhances the overall potency of presentation. Several studies have demonstrated that Ii-Key/HER2(776-790) hybrid (AE37) induces more potent immunologic responses, both in vitro and in vivo, compared with the non-modified HER2776–790 peptide (AE36) [90]-[92]. Indeed, the Ii-Key hybrid AE37 has been shown to generate robust and long lasting HER2-specific immune responses in women with breast cancer. Preliminary data from a phase II study evaluated AE37 in women with breast cancer suggested a better outcome and indicated that the Ii-Key hybrid technology is capable of enhancing the potency of peptide immunotherapy for cancer [92].
The results of the first human phase I trial of the Ii-Key hybrid HER peptide (AE37) vaccine in women with early stage node-negative breast cancer demonstrated vaccine induced dose-dependent immunologic responses, in vitro and in vivo, to AE37 and AE36 (unmodified type), and showed that the hybrid AE37 vaccine was safe and well tolerated with minimal toxicity if properly dosed. AE37 is capable of eliciting HER2-specific immune responses; even without the use of an adjuvant [93]. This trial represents the first human experience with the Ii-Key modification. Due to the fact that no immunoadjuvants was added, the AE37 is the first peptide vaccine to show potency in the absence of an immunoadjuvant.
Furthermore, at the median follow up period of 22.3 months, 49% reduction in risk of breast cancer recurrence was noted in women treated with the AE37 peptide vaccine compared with the immunoadjuvant, GM-CSF alone. The risk reduction was higher (68%) in women with low HER2 expressers (HER21 + or 2 + on immunostaining) breast cancer [94], which is in line with the general concept that patients with biologically less aggressive disease may respond better to vaccination. Discussion on why HER2 negative patients had better outcome after vaccination is not within the scope of this work.
ADF opioids are like airbags and anti-lock brakes.
People die from many causes including use of automobiles, motor cycles, house fires, and even riding houses
Great find, SCHH. Very interesting read.
http://www.cnn.com/2015/04/24/health/hiv-indiana-spreads/index.html
Another reason this infection has spread so rapidly is the nature of the drug itself. Opana, as the prescription opioid is known, needs to be injected more than once a day. Duwve said residents have reported injecting it four to 10 times a day to stay under its influence. When people start to feel the drug wear off after about four hours, they begin to feel sick and go into withdrawal. Often they'll turn to an injecting partner in the same house who will share their needle and their drug to give the person relief from these symptoms.
The other Phase III specifically describes naltrexone pharmacokinetics.
https://clinicaltrials.gov/ct2/show/NCT02391571?term=Elite+Laboratories&rank=1
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
Secondary Outcome Measures:
Secondary: Pharmacokinetic Profile of Naltrexone and 6ß-Naltrexol in Subjects receiving Oxycodone/Naltrexone [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
To investigate the multiple dose pharmacokinetics of naltrexone, and 6ß-naltrexol following repeated daily administration of Oxycodone/Naltrexone in methadone-maintained opioid dependent subjects. All subjects enrolled will have 3 PK samples taken during the placebo period and 3-13 samples taken during days 6-10 of the study. Samples will also be taken during the wash-out period, 2 on Day 11, then daily through Day 14. T max, Cmax AUC Ctrough and apparent first-order terminal elimination half-life will be calculated as part of the PK profile.
Hi Meschan,
We've been debating this issue re: identity of ELI-200. It is interesting that as we were going back and forth on this MB that clinicaltrials.gov was amended by the company to make it less specific. It used to say immediate-release oxycodone in the title and it used to give a dose of 15mg. Not sure what it means that those details were omitted. I have been advocating the idea that ELI-200 may be a novel formulation, specifically, an immediate-release oxycodone with controlled-release features. Pure opinion and speculation, of course, but here are some of my earlier posts that explain my reasoning, based on the earlier version of the trial details:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112279272
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112292755
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112294555
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112300471
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112398538
Have a great day everybody! Buy, hold, accumulate ELTP.
great info, thx
Rethink Opioids: Universal Precautions Approach for Prescribing Opioids
More thoughts on our earlier discussion regarding marketing. During the last conference call, Nasrat Hakim said something I found very interesting:
http://seekingalpha.com/article/2927936-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q3-2015-earnings-call-transcript?part=single
The second thing is that I welcome people like Pfizer into the market and let me explain why. Pfizer is the company that invented statins. Statins are what you use like Lipitor when you have high cholesterol, okay. Their scientist invented the molecule, understood its characteristics went out there, educated the doctors, educated the FDA and the created this markets where everybody in the country now is on it, when Pfizer is leading the field ahead of us and their oxy with naltrexone, then that’s a great news for us because they are paving the way for us to get in, number one.
Number two when a company like Pfizer embraces the technology which little Elite has that would tell you that we have as a gold cup, okay. So this is how I look at it, it’s very positive, this is a wonderful thing that little Elite has the same thing that Pfizer had and maybe a little better and second Pfizer is paving the way for us, another giant is going to jump in and want to partner with us down the road in order to compete with Pfizer.
Doc, you've probably got the inside scoop.
Any of your sources tell you the details of how the case was settled? Treppel was apparently fired from B of A, as I said both sides took some bruises. But he also seems to have been partially vindicated, as Melnyk was eventually sanctioned by both the OSC and SEC.
http://business.financialpost.com/news/fp-street/melnyk-could-face-5-year-ban-from-the-boardroom
He was forced to step down and go spend his billions elsewhere. But there was never a peep from either side about the out of court settlement with JT. What do your sources tell you?
I can guess one company NOT being considered.
I doubt Chairman Treppel would allow any discussions with Valeant, which merged with BioVail back in 2010. Treppel and BioVail CEO Eugene Melnyk had a prolonged and public rivalry (hatred), thus leading to one of the greatest sentences ever written about a stock analyst EVER.
http://www.canada.com/story_print.html?id=89c98fe7-c425-4f93-9881-add12f4348bb&sponsor=
If Jerry Treppel was cast in a Hollywood western, he'd be the steely-jawed cowboy who rides into town to lock eyes with his nemesis one last time, just before the man hangs from the gallows at the end of Main Street.
In Treppel v. Biovail Corporation, the
court authorized the plaintiff to conduct, at the defendants' expense, a "thorough forensic examination"
of a laptop computer used by Biovail's Chairman and CEO based on what the court found to be "clearly
deficient" efforts on the company's part to preserve electronically stored information ("ESI").
Buyout price triples with 1 approved product.
IMO the route with a partnership for sales/marketing may get us all to a buy out quicker and with more reward for shareholders.
DrugCo's expend great effort to get to my eyeballs.
While manufacturing is not an issue, there is nothing in their current skill set that suggests they have the ability to market & sell ADFs into the opioid pain med market.
"Gifting" warrants = lack of transparency
(1) $ELTP wants the warrants cleared out.
(2) $ELTP wants the monies in their treasury now.
(3) $ELTP wants the warrant derivatives removed from the acounting for the 10-Q and 10-K
(4) $ELTP wants clarifed accounting scenario for their potential
Partnerships and/or sale of the company to Major Pharma
What is the Restricted Legend?
Restricted $ELTP Warrants can only be converted thru $ELTP for conversion to shares so that the Restricted Legend remains.
It appears to me these warrants were gifted.
As you all will recall, back in August Narine Jeenarine gifted 2M shares to his son. Compare the two Form 4's.
Narine Jeenarine's Form 4 from Aug 12, 2014:
Ashok Nigalaye's Form 4 from April 16, 2015:
The only difference is that Narine Jeenarine provided an explanation regarding to whom he was gifting them. Apparently Ashok Nigalaye is a more private individual....
Unless somebody knows differently, it does not appear they were converted before they were gifted. And I would have to agree with IB that once they're out of Ashok Nigalaye's hands then their whereabouts become permanently unknowable. Not aware of any restrictions on the warrants- is anybody else aware of any?
Is there an advantage to converting sooner/later?
What I'm trying to figure out is if there is a reason to convert now vs. just before a buyout. Does the share price at the time of conversion have any tax implications for the holder when the common stock is eventually sold? Other than ~$65,000 out of pocket, is there a reason to not have converted his other million warrants now as opposed to say in 1 year when the share price will be (presumably) higher?
Also, 'ice n ak' made an interesting point:
Acquiring companies hate buying companies that have warrants survive a merger and allow the warrant holder to buy equity in the acquirer.
Lasers or anybody, how do these warrants work?
Specifically, how are these conversions treated for tax purposes? Also, approximately how many warrants are left to be converted at this point?
Uncle Sam gave me only a gentle reaming...
No big tax bill this year, so I added another 25,000 shares of ELTP.
Buy, hold, accumulate. Get 'em while you can.
Lasers, will Plaintiff discuss Elite's superior ADF tech?
Seems like timing will be terrible for Purdue. Just about the time this case comes to trial, FDA will be approving Elite's 2nd ADF-opioid, 12 hour oxycodone, with equivalent efficacy to OxyContin and immaculate HAL data. Plaintiff's attorney will have a great time questioning Purdue about why they let their exclusive license to Elite's well-proven ADF lapse back in 2004. Took them until 2010 to release their easily-defeated hardshell ADF. Hundreds of thousands of addicts and thousands of deaths during that time period.
Purdue's got some 'splaining to do, and I question whether they will really want to have to also explain why they're suing Elite to keep superior pharmacology-based ADF off the market, especially if the HAL data shows superiority over hardshell OxyContin.
I have no idea whether these suits against Purdue will be successful, but I do believe they will have an effect on Purdue's litigiousness. I understand their prior history of "Sue 'em all and ask questions later," but their special relationship with Elite's ADF, dating back more than 10 years, just may be an Achilles Heel that they'd rather not expose of their own free will.
I predict Purdue will not sue Elite.
Let's ask Warren...
When would you say the pps starts to matter then?
If you bought in as a long (somehow there is a concept of a true long on this board) say end of April last year you are now looking at a 50% loss over a 12 month period.
Amen Brother.
This person is one who lives and works in what is known in general medicine as the "Ivory Tower". These are generally professors the MD PHD types some who claim to have private practices but still seem to miss the realities of the world such as insurance coverages, program availability and oh, did I mention money and time.
John, help me understand how your graph works.
Specifically, how would my shares be recorded? I bought a very large majority of my shares (>75%) with a limit order. I set my target price below the bid and waited for price to drift down to my target. Most often I would get a partial fill then the price would go back up for a while and eventually drift back down to my target again. For larger orders, there would be 3 or 4 partial fills before my order was completed. Occasionally, the price would not come back to my target and I was left with only a partial fill.
As I understand your graph, >75% of my shares that I bought and am (strongly) holding were actually "sells." Am I correct? If not, how not? And if this is correct, then how is your graph at all relevant to anything? It means nothing, especially if there is wash trading.
I always hate dry powder on a green day, and my used car was new to me.
You are 100% correct, kayak wrench
In my personal experience it isn't the doctor that drives changes in my prescriptions, but my insurance company.
Rebuttal: “The Big Money Is In Extended-Release”
A few participants in our discussion this week have suggested that the market for immediate-release opioids may be “nice” but “the big money is in extended release” opioids. On a per prescription basis, that is absolutely true. But as we’ve shown in multiple graphs, the number of prescriptions for immediate-release opioids outpaces extended-release scripts by a factor of nine to one. The total dollars in U.S sales are about equal: $3.9 billion for IR vs. $4.1 billion for ER (2012).
No doubt extended-release opioids for chronic pain represent “big money.” But many of the patients in that market are already on a stable regimen with an abuse-deterrent formulation. The FDA has already given their approval to hard-shell and gummy-shell ADF (OxyContin, Zohydro). We know, and the HAL and efficacy studies will prove, that our two-bead, modular, pharmacology-based ADF with naltrexone is the very best for multiple reasons. But the FDA has repeatedly re-enforced that physical barrier ADT is good enough, and I strongly doubt that any doctor is going to change a patient who is stable on a medication to an entirely different medication just because naltrexone-based ADF becomes available.
For this reason, I believe that our naltrexone-ADF opioids will gain market share mostly with “new users” and less with “current users.” For chronic pain, when a patient is being started on extended-release opioids for the first time, naltrexone-based ADF will garner a percentage of these prescriptions and will build market share slowly over time. But immediate-release opioids, which account for 90% of the prescriptions, are used primarily for acute pain, and all acute pain patients are “new users.” And since there are very few competitors with immediate-release ADF opioids, Elite’s naltrexone-ADF will build market share in the immediate-release opioid market much more quickly than it will build market share in the extended-release market.
So to those who say the big money is in the extended-release market, I say I agree. But the early money, and easiest money, is in the immediate-release market. And the greatest part is that with Elite’s modular two-bead technology, we’ll quickly be gaining market share in every market: oxycodone, hydrocodone, morphine, hydromorphone, oxymorphone, extended-release, and immediate-release.
This is actually a great point, Chasing.
or maybe, just maybe, there aren't enough people having the procedures done that involve this study or maybe, just maybe, there aren't enough willing participants
Types of bunion surgery
Removal of part of the metatarsal head (the part of the foot that is bulging out). This procedure is called exostectomy or bunionectomy.
Realignment of the soft tissues (ligaments) around the big toe joint
Making small cuts in the bones (osteotomy) and moving the bones into a more normal position
Removal of bone from the end of the first metatarsal bone, which joins with the base of the big toe (metatarsophalangeal joint). At the metatarsophalangeal joint, both the big toe and metatarsal bones are reshaped (resection arthroplasty).
Fusion (arthrodesis) of the big toe joint
Fusion of the joint where the metatarsal bone joins the mid-foot (Lapidus procedure)
Implant insertion of all or part of an artificial joint
Anybody wish to comment on this?
The verbiage of the Phase 3 official title as it appears in the archive:
And now the verbiage of the Phase 3 official title as it appears today:
What do you say to that, Doc? Where did immediate-release go?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112385278
Seems to me that some hypothetical company, perhaps a company that "specializes in oral sustained and controlled release drug products" just might be able to create a single agonist bead that mimics the plasma concentration characteristics of both an IR and ER product. One could theoretically, albeit in-artfully, refer to such a product as intermediate release.
Hi Satman, you are not addicted.
How does one know if they are addicted to Oxycontin? I have been taking 60mg 3 times a day for close to 2 years.
Study is poorly designed to test only naltrexone.
IMO then, this FDA pain efficacy trial is then trialing the Naltrexone sequestering polymer over 48 hrs with eight 15 mg IR Oxycodone while still maintaining pain relief. In 48 Hrs the Naltrexone beads will be throughout the patient's body from stomach, blood and Intestinal tract and exposure range thru hi acid, hi alkaline fluids as well as metabolizing enzymes environment.
Thank you for this thoughtful reply.
while there are many prescriptions written for IR Oxy, the dollars are with the ER version. Egalet recently licensed IR Oxy from Acura. In that agreement a milestone threshold is described, $150 million. Usually these milestones are fairly lofty goals and usually are set for 5 years or so out.
Immediate release is just that. No polymers or coatings that delay the release. Common terms would be delayed, or controlled or extended release
You may be right, doc...
So you agree, then, that ELI-200 is an abuse-deterrent immediate-release oxycodone product. What do you think of the potential of such a product?