Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
hotelbar, I'll believe it when I see it
The research sites are definitely recruiting.
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.
Great find, SCHH. Very interesting read.
http://www.cnn.com/2015/04/24/health/hiv-indiana-spreads/index.html
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
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
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=
Buyout price triples with 1 approved product.
DrugCo's expend great effort to get to my eyeballs.
"Gifting" warrants = lack of transparency
What is the Restricted Legend?
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:
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...
Amen Brother.
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
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.
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
Hi Satman, you are not addicted.
Study is poorly designed to test only naltrexone.
Thank you for this thoughtful reply.
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?
Doc, pure speculation on my part...
Right on the money, jimneutron.
Correct. 2 or 3.
We already have it.
Started my career in an urban emergency department.
Deep South (LorTab, y'all?). 12 hour shifts. There are only a few things in medicine that are immediately gratifying (and even fewer at 3am): lancing puss under pressure (abscess), evacuating a subungal hematoma (blood under a fingernail), etc. My personal favorite was punk kids with altered mental status. Push the Narcan (IV naloxone) and/or IV flumazenil and watch them wake right up and give you THAT look. The look that says, "Who the F### are you and where the F### am I?" One kid said, "What the hell are you doing in my bedroom?" Occasionally, they would be VERY PISSED about being induced into an immediate opioid withdrawal and would try to attack you. We had a nurse who was retired Navy Seal, and he was the one I always looked for to push Narcan. He could put ANYBODY down with one touch, one hand. I always tried to get him to show me how he did it. He said he would, but then he'd have to kill me.