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sharkey1, hard to say...
won't they want to keep this as quiet a possible for various reasons, starting with this stock price.
All 165 patients could be done in six weeks.
These research centers are mostly Monday-Friday operations. It's no accident that the study is designed with a 4 day stay. All surgeries will be done on a Monday, and all patients will be discharged on Friday. The place closes over the weekend, and the whole process is repeated the next Monday. Each center is only limited by the number of surgeries that can be done in one day (Monday), and they will want to have as many inpatients at a time in order to be most cost-efficient. One surgeon could do 3-4 surgeries Monday morning and 3-4 surgeries on Monday afternoon, for a total of 6-8 patients per week per research center. Add a second surgeon, it could be more.
Being conservative:
6 patients per week x 5 research centers = 30 patients/week.
165 patients / 30 patients per week = 5.5 weeks
In other words, starting surgeries on Monday June 1, every patient could be operated on and discharged from the research center by Friday July 10. Elite's protocol estimates primary completion in July, leaving 3 whole weeks for busier centers to compensate for slower centers.
Totally on target for final completion in August 2015, as stated.
https://www.clinicaltrials.gov/ct2/show/study/NCT02401750?term=oxycodone+and+elite&rank=1
GNBT starting to get attention.
Welcome mick, stop by sometime! GLTA.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113497978
One of our two main tech plays here is a drug-delivery system for the buccal delivery of various drugs (Rapid Mist). Many drugs are potential candidates for buccal delivery, which has multiple advantages, including rapid, painless systemic drug absorption, avoiding first-pass metabolism in the liver, and avoiding drug delivery to the lungs. Generex holds extensive international patents on this type of buccal delivery system. Drugs in active development include insulin and cannabis.
The other technology is a plug-and-play hybrid-peptide vaccine delivery system being developed by our wholly-owned subsidiary, Antigen Express. Any peptide vaccine can be plugged in and tagged with a 4 amino acid moiety (Ii-Key). The hybrid peptide is an MHC II epitope which has been proven to stimulate more robust CD4+ and CD8+ response than the peptide alone. The current vaccine under development, called AE-37, has completed Phase 2 and final results will be presented at ASCO this month. Preliminary results showed 49% reduction in risk of recuurent breast cancer but a much greater risk reduction (68%) in women with low HER2 expression, who are not eligible for current standard of care with Herceptin. GNBT longs are hopeful for an announcement soon on an AE-37 Phase 3 study, either alone or in combination with other petide vaccines. The same molecule is being tested in prostate cancer, but any peptide could be plugged in, and previous suggestions include influenza and ebola vaccines.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113115135
Um, yes, that was a joke.
Who are the "MMs" going to find to sell 60 million ELTP shares between $0.225 - $0.215 ????
"Hedge Fund: Yes, this is what our extensive DD on the ihub MB tells us."
Is that a joke? Hedge Funds do their "DD" on a message board ??
Yeah ok,
IB_
Who are the "MMs" going to find to sell 60 million ELTP shares between $0.225 - $0.215 ????
MM "bid support" = Hedge Fund Buyer
If you believe there is MM bid support, and if you believe that MM's always act in their own self-interest, then probably somebody who already holds a lot of shares is quietly buying a lot more shares, and that somebody is probably a micro-cap hedge fund. They want their shares cheap but not too cheap. The MM's, as always, are acting rationally and just following instructions-- keeping the price range in the sweet spot that the hedge fund has requested.
I like the thought but those shares are sold as quickly as possible.
Why would an MM support the bid?
I would guess that the run up to .97 caused a "reset" of the break-even point among the MM's. Back when it hovered around .07 and then .12, they had a different break-even point. They did all their selling, naked shorting, covering, and reloading during the run-up and retreat, and now their current buy-in level is low .20's. Letting it go too far below the buy-in level would not be good for them. For a short period it would allow them to reload the boat for next move upward, but after a while they would have a full boat and would not want to price to fall below the average PPS of their current boatload of shares.
The MMs do not hold that long they unload the same day or the next.
Not saying I agree with "bid support"
As I have said the MMs are supporting the PPS of ELTP like I have never seen them do before (they make more money at a lower PPS)
J-La, I like your MM analysis posts.
we saw that and now the MMs are backing off the bid support as the MMs VNDM and BKRT move on the ask. If you see the MM VFIN move to the ask with a 2500 bid; RUN!!!
dr_lowenstein, I agree 100% with your Custer analogy.
Naz is like Gen Custer. While good at slogans and pomp and circumstance the others (aka Sitting Bull) are executing their plans flawlessly. Custer had an over-reliance on the superiority of his fighting forces with no evidence of such superiority. Sound familiar?
Collegium is our competitor and our cousin.
Somebody asked yesterday if Collegium was truly our competitor, and I did not have time to reply but thought it was a great question.
All of these companies that are working on ADF's are our competitors in the upcoming ADF Wars. But at the same time, we are tied to the hip with them. We need them to be successful in getting their ADFs to market, and we need those ADF products to not be disgraceful failures (see Embeda-1). If you do not believe the FDA when it says it will remove non-ADFs when there are viable ADFs, then stop reading now.
I believe that when there are a plethora of available ADFs, then all non-ADFs will be snuffed out like a mafia snitch with his back to the door. The FDA has said so, and there is great pressure from Congress (Manchin et al), state AG's, and various public advocacy groups that will keep the FDA honest on this issue. At some unknown point in the future, every opioid will be an ADF. However, the FDA is not going to hand over to one or two companies a monopoly (or even oligopoly). They will require a healthy market of ADFs, and that is why Collegium is both our competitor and our cousin. We need Collegium and Egalet and Acura to be successful. Once their products are available and every opioid is an ADF, then we can compete with them based on the merits of the ADFs, instead of competing with nonADF generics based on price. And thus will begin the ADF Wars.
What are the ADF Wars? It is not yet well-defined how stringent the FDA will be in approving various ADFs. I tend to believe the FDA will act like a bouncer at a college bar. You have to show him an ID that says you're over 21 but he's not going to pay much attention to the picture or that Ohio is spelled wrong. He's going to let everybody in that can show him an ID, no matter how questionable the ID. But once you get into the bar, now you have to compete with everybody else based on individual merits.
When a drug rep comes to the office to detail a drug, they usually don't just tout their own drug but also throw in a line or two about why they're better than the competitor. An obvious example are the long-acting insulins, Lantus vs. Levimir. I always make time for their reps because there are no generic equivalents and they give me samples. Even with good insurance, the copay can be $100/month. So calling an indigent patient and telling him you have samples is like telling him to come pick up a $100 bill. In my district, the Lantus rep and Levimir rep are brothers, so its a very friendly rivalry, but they never see me without mentioning at least one reason why their drug is superior to the other, usually with a graph.
Recent Lantus sales pitch:
That's how it will be with ADF Wars. There will be a great rivalry between the types of ADFs, i.e. mechanical barrier vs. aversive agent vs. pharmacologic. There will be graphs. "Ours is better than theirs because..."
Also, too, this is why we should all be rooting for Embeda-2 and its oxy sister, ALO-02. I see some posters on this MB hoping for a repeat failure of Embeda, but that would be the worse thing that could happen for Elite's technology. Not only do we want Pfizer out there pressing the issue of why pharmacology-based ADF is superior to mechanical barriers, but we also do not want our competitors out there pointing out that pharmacology-based ADFs with antagonists are inherently unstable. Our modular 2 bead technology is great because it is interchangeable, but if naltrexone ADF gets a bad name because Embeda-2 and ALO-02 are miserable failures, then no physicians are going to give a crap about our 2 beads. They will not use it. (Failure of Embeda-2 and ALO-02 is the second biggest risk to my ELTP investment). I can't believe I'm saying this, but I'm rooting for Pfizer on this. GO PFIZER!!
As for Collegium specifically, they have an interesting ADF. More on that some other time.
Stoner dogs get the munchies.
How would meddcanns dog study help gnbts oral-lyn get fda approval
Hard to follow these Canadian cannabis players.
CannScience Innovations now owned by MedCannAccess now owned by Peace Naturals Project. Clearly a fetal industry in great flux. A few local press articles out there but not much. And such is the case for all the marijuana stocks. Blink your eyes and they're gone. Eaten up by a bigger a fish or BK. Wouldn't mind seeing a big fish swimming towards GNBT...
GLTA
Sorry I'm "gloomy" at Mutual Admiration Society Meeting.
Smart investing is like smart writing. It's okay to break the rules as long as you understand the rules you are breaking, and as long as you break them with intention and purpose. Otherwise you just look ignorant and foolish.
My investment in ELTP breaks every rule. It's at the pinnacle of the risk pyramid. I have way too much money invested in a stock that costs less than a dollar and trades OTC, and I'm not properly diversified. I’ve done very well so far, but instead of taking profits, I keep buying more. If I ever showed my brokerage statements to a Registered Investment Advisor, I'd probably have to perform CPR on him. However, there is one rule I will not break: I do not have more at risk than I can afford to lose. Every year, we max out our 401K’s and Traditional IRA’s in “Retirement 2040” funds. But I don’t want to retire in 2040. I want to retire in 2021, and for that to happen, I need huge returns. Huge returns require huge risk- it requires breaking the rules- and I break them with intention and purpose. I accept huge risk, but I asses that risk constantly and understand it thoroughly.
I get the impression that some posters on this MB have no clue the kind of risk they’re involved in. If you rely on Investor Relations to answer your questions, you’re in trouble. Save your TRUST and FAITH for church. This is about MONEY, and I’m a scientist. I require FACTS and EVIDENCE. And when I don’t have them, I seek them. And when I’ve just proven I don’t have them, I don’t call others nonsensical.
kayak wrench, i'm already on the record...
...as both paranoid and cynical. And I'm already on the record as considering Epic to be the single greatest risk to my largest investment, my holdings of ELTP. My ELTP investment is worth more than my house, and I have a very nice house.
I'm not here to RA-RA-RA everything this company does, nor to bash it. You read every one of my posts and see that I shoot straight down the middle. I'm here to protect my investment by bringing to light any truth that I can.
It's fine by me if you are not concerned that the CEO has a secret relationship with the majority shareholders of a company in which you are a minority shareholder. I agree 100% with what N2KA just said. Secrecy causes you to question the reason for the secrecy. It undermines confidence. Make it public, so there are no questions about why it's a secret.
And here are my paranoid delusions about how Epic is the single greatest risk to my ELTP investment, which were in response to question about a potential Epic-ELTP merger:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113217587
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113220620
And remember, just because I'm paranoid does not mean they're not out to get me.
Pharma Sleuth, I thought of that possibility.
So when those shares were all dispersed to the original investors, I suspect Mikah was one of them. It only makes sense since we know there was a relationship with Epic and Mikah long before Nasrat came on board.
pte, Clarendon, kayak wrench, lasers... anybody can answer...
There is nothing in NOTE 25 of the latest 10K that describes why NH or Mikah is entitled to receive shares of ELTP *****FROM EPIC*****
Thanks for referring me to the 130 page 10-K and the link to the Elite Investor Relations SEC filings page. Very helpful. I am well-familiar with why NH received ELTP shares and warrants **from Elite**. But if anybody can point me to the public disclosure that explains why **EPIC** is compensating NH and Mikah with ELTP shares, I would greatly appreciate it.
pte, can you be a little more specific?
See Footnote 25 to the financial statements in their last 10K
kayak wrench, this is the exact question...
Mikah had rights to warrants, it needs to acquire them to liquidate them.
no2koolaid, what is your opinion on disclosure?
Should there not be a public disclosure regarding how and why Epic is giving ELTP shares to NH, NH's IRA, and Mikah? Likewise with the Mikah labeling on hydroxyzine?
Clearly there exists a relationship between Epic, Nasrat Hakim, and Mikah. Why is this not publicly disclosed?
"Sunlight is said to be the best of disinfectants."
----Justice Louis Brandeis
Lasers, what about the Epic distribution to Mikah?
Under what authority or agreement is Mikah receiving shares of ELTP from Epic? Shouldn't those shares go into Elite treasury? Same question regarding Nasrat Hakim? Would it not be considered a material disclosure if Elite CEO has a separate and individual business arrangement with Elite's strategic partner Epic Pharma, outside of the relationship between Epic and Elite? Did I miss this disclosure?
Medicinal buccal cannabis troches.
http://www.trokie.com/product-info/
You will notice the Trokie medicinal effect in 5 minutes!
Trokie’s patented buccal or sublingual delivery mechanism ensures the fastest medicinal effect. The Trokie uses the buccal absorption which allows for one of the fastest delivery of Cannabis pain relief and will prolong the clinical effect.
Buccal or sublingual absorption allows the medication to avoid the First Pass Effect of metabolism (metabolized by the liver); unlike taking an edible which could take up to an hour to feel the effect (which leads to many people overmedicating using edibles)
IB posted the label; I'm confused by it.
Hopefully we can get an explanation for this. May have something to do with site transfer technicalities. I already posted that I was surprised when Nasrat Hakim got share distributions from Epic, including under Mikah, which I thought was a defunct entity. Now the hydroxyzine label has Mikah's name on it?
Lasers? Anybody?
Huh. Not exactly "ceased operating" or "liquidating assets"
Epic's Hydroxyzine label:
http://epic-pharma.businesscatalyst.com/assets/hydroxyzine-hcl-tablets-usp-package-outsert.pdf
4/27/2015 4 Statement of Changes in Beneficial Ownership
http://b2i.api.edgar-online.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=Zy-kefa7j5MBo-9&ID=10648486
2/17/2015 10-Q Quarterly Report
http://b2i.api.edgar-online.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=Zy-kefa7j5MBo-9&ID=10492671
Termination of Development and License Agreement with Mikah Pharmaceuticals
Pursuant to the Mikah Development Agreement, Mikah Pharma LLC ("Mikah") made advance consideration payments to the Company totaling $200,000 in exchange for product development services to be provided at a future date. Subsequent to the execution of the Mikah Development Agreement, and before any development milestones were achieved, the sole owner of Mikah, Mr. Nasrat Hakim, became the President and Chief Executive Officer of the Company. Mikah has accordingly ceased operating and is in the process of winding down and liquidating its assets.
agrocraig11, ELTP and GNBT are both IP plays
They both hold extensive patents on legitimate technology with major market potential. I hope that GNBT will find its savior the way Jerry Treppel came to Elite, saved them from BK with Epic Pharma partnership, built a revenue base with generics, and now has handed the reins to Nasrat Hakim to develop their true money-makers, the abuse-deterrent opioids.
To have the insight that he was not the right guy to lead the company into the next phase of development and the judgement to bring in a guy like Nasrat Hakim to get the job done is extremely enviable. Remember when Elite was trading for a few pennies? Now at .22 and headed to multiple dollars soon. GNBT could do the same, but they need a Jerry Treppel and Nasrat Hakim. They have the technology but seem to be missing the leadership.
Nice to see you over here, keep on postin'! GLTY.
JJ, you're invited to a "Hairy Buffalo" party.
The junkie will have to spend about $25-$35 thousand for the centrifuge. And there is no guarantee this will work.
Depends on what your definition of "is" is.
Dianne; also said the TA was not gagged when it is!!!
Did she? How do you know? Link?
Dear Mr. ________,
Thank you for contacting our Shareholder Services Department.
We are unable to confirm your position as they are held in a brokerage account. Please contact your broker directly.
We are unable to verify the total outstanding shares for Elite Pharmaceuticals Inc. Many times this information can be found on the company website.
In the event you require additional assistance, please contact our Shareholder Services Department at info@amstock.com.
We trust the above information is helpful.
Sincerely,
Stephanie Slight
Correspondence Department
Formulation and evaluation of simvastatin buccal film
Journal of Applied Pharmaceutical Science Vol. 5 (04), pp. 070-077, April, 2015
Simvastatin is water insoluble crystalline powder (Ungaro et al., 2010). It undergoes extensive first pass metabolism in the liver which results in very low and variable oral bioavailability. The properties of drug like short half-life (2-3 hour), small dose size (5-80mg) and low molecular weight (418.57) makes it suitable candidate for administration by buccal route (Hiremath, 2009). This route of administration is expected to overcome the problem of poor oral bioavailability by at least avoiding the presystemic metabolism of the drug.
The developed films are promising for buccal administration.
I'm interested. How will it be defeated?
the junkies will figure it out and I know exactly how they will do that.
Hi agrocraig11, the reverse split parameters are undefined.
Does anyone know what the RS would be....from looking at past Press Releases I saw that in 2011 they approved the RS at a minimum of 1 to 2 and max of 1 to 10 for the RS. Not sure if this still applies right now or that offering from 2011 has expired.
Either way they would have to implement a high RS ratio for there to be any significant push since this is still trading in the 0.02 cent range.
Another spurt of buying with new "Intention" PR.
http://finance.yahoo.com/news/generex-announces-intention-dividend-portion-133000825.html
In consideration of the license grant, SMFI will issue to Generex (a) $10,000,000 worth of SMFI common stock, and (b) a warrant to acquire up to 15,000,000 shares of SMFI common stock. The per share strike price of the warrant will be determined based on the average closing price of the SMFI common stock on the OTCQB for the 10 trading days immediately preceding the effective date of the qualifying registration statement. If that price is equal to or less than $3.00, the strike price will be $1.30. If that price is greater than $3.00, the strike price will be equal to 43.34% of that reference price.
Management of Generex intends to dividend a portion of the SMFI common stock and a portion of the warrant to acquire SMFI common stock to its stockholders following implementation of a reverse stock split. Generex stockholders have previously approved the implementation of a reverse stock split at any time prior to December 31, 2015. The ratio of the reverse stock split and the specific timing thereof are in the discretion of the Generex Board of Directors.
The warrant will be exercisable by Generex stockholders for cash only for a period of 90 days following the issuance of the dividend. Any portion of the warrant unexercised by the Generex stockholders during such period will revert back to Generex.
"Low Road" paved with cash, leads to NASDAQ.
I never thought elite would take the low road an pursue acute pain
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.
gerhan, I think you're on the right track...
Perhaps India is waiting for FDA approval here in the states.
grobtekrebssvindl, there will be no news from India.
Oral lyn,the same.Top of that the India "fiasco" was 7 years ago.. kind of strange Fletcher said in the interview India is slow.This slow?
Awesome veeets! Great DD. Thanks.
This is what I've been looking for:
Saturday, May 30 | 8:00 AM - 11:30 AM
Breast Cancer—HER2/ER
Session Type: Poster Session
Track(s): Breast Cancer
Presentation(s):
Abstract #622
Final pre-specified analysis of the phase II trial of the AE37+GM-CSF vaccine in high risk breast cancer patients to prevent recurrence.
Julia M. Greene, MD
San Antonio Military Medical Center
Welcome gerhan. You must be new to GNBT.
I appreciate your posts, but the management of this company, current and previous, have a bit of a habit of making statements that don't pan out. I've listened to Mark Fletcher's interview on Wall Street Analyzer- tyically tantalizing, low on specifics.
Again, one can go to the ASCO site and look for one's self. There are no current listings for any presentations that involve AE37. No oral presentations, no posters. If I'm wrong please link to the presentation or provide the title or presenter. I want to be wrong! I want AE37 at ASCO! But this meeting is coming up this month. All the sessions are already set- have been for months. The company released the ASCO PR in February. Where is AE37 at ASCO?
https://iplanner.asco.org/am2015/AM2015.aspx
We'll know in less than one month: was the February PR about an ASCO presentation a complete fabrication?
If so, then it's time for the true scientists associated with Generex and Antigen Express to stand up and call for the resignation of Mark Fletcher.
Dr. Eric von Hofe, Dr. James H. Anderson, Dr. Gerald Bernstein, Dr. George E. Peoples, Dr. Joseph Rubinfeld-- I'm looking at you!
Hi gerhan, can you provide a link?
AE37 is a poster presentation at ASCO on May 29
But go to the ASCO library site and search the abstracts...
https://iplanner.asco.org/am2015/AM2015.aspx
I got zero results searching for AE37, mittendorf, generex, and many other permutations. I've heard of ASCO embargos on data, but not on abstracts and presenters. We'll know in less than one month: was the February PR about an ASCO presentation a complete fabrication?
If so, then it's time for the true scientists associated with Generex and Antigen Express to stand up and call for the resignation of Mark Fletcher.
Dr. Eric von Hofe, Dr. James H. Anderson, Dr. Gerald Bernstein, Dr. George E. Peoples, Dr. Joseph Rubinfeld-- I'm looking at you!
The Company plans to disclose the latest results from the Phase II clinical trial at this year's American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29 to June 2, 2015.
Bill to Speed Approvals for Drugs Cut Back
By SABRINA TAVERNISE
APRIL 30, 2015
http://www.nytimes.com/2015/05/01/health/bill-to-speed-approvals-for-drugs-is-cut-back.html?_r=0
Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.
The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.
Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety; for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug's effectiveness and safety.
The draft, at about 200 pages it is half its former size, seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.
The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.
I bet ELTP is a trader's dream stock.
I have been a trader in ELTP since 2011.
I am not a day trader.
And very happy.
grobtekrebssvindl, thanks for the link
I had not seen that interview. I think it would go a really long way if Generex would bring in some fresh blood. Somebody with both Scientific chops and Management chops, of which M. Fletcher has neither. Bringing in someone with positive experience running a developmental-stage biotech would maybe assuage some of the restless, disgruntled longs and also attract some newbie investors.
The question is if anybody good would even take the job!
GLTY