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Dang I know it hogfan2. I'm an addict.
Damn weez...you should have sold a long time ago....that stock has been disappointing you for some time now...hog
doogdilinger, you've got the wrong guy.
90% of my position was acquired under the old regime, under 8 cents. And Yup, our guy is quite accomplished at "CEO Speak," just like they all are. If you don't think you're also getting some sunshine blown up your rear-end, you better go back and re-read the precise language in IPCI PRs. Your CEO is well-accomplished in "CEO Speak", too.
And I am very interested in IPCI. I'm just waiting for PPS to grind down below $2. Maybe I will use some of my ELTP proceeds when ELI-200 is FDA-approved next year.
doogdilinger, I'll take that as a ---No---
They had to re-do their phase I trials with PODRAS incorporated into Rexista k WeeZuhl...and that's what precipitated the FDA's 2 recent decisions...
1st to grant them designation for fast track status...then to immediately follow that fast track decision up by advising them that they were so impressed with phase I that they could skip phase III trials entirely and simply submit bioequivalence prior to officially submitting their Rexista NDA k cheers!
doogdilinger, I agree you with 100%
An ADF which prevents oral abuse and overdose would stand alone in the class and would be a game-changer. Likewise, I think the generic pipeline of IPCI is very attractive, as is the share structure. But I am confused about a few things and so far have had limited success in finding further info, so maybe you could help me.
The technology which limits oral abuse called PODRAS was announced by PR in August 2014:
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=868259
August 28, 2014
Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Novel Overdose Deterrence Technology
TORONTO, Aug. 28, 2014 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced an enhancement of its Rexista™ abuse-deterrence technologies with a significant improvement designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics' new platform technology is branded PODRAS™ (Paradoxical OverDose Resistance Activating System).
Rexista™ Oxycodone XR
Rexista™ Oxycodone XR is a non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required. The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting.
May 26, 2015
FDA Grants Fast Track Designation for Intellipharmaceutics Rexista(TM) Oxycodone XR Incorporating PODRAS[/b](TM) Technology
TORONTO, May 26, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista™ Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System ("PODRAS™") and has concluded that it meets the criteria for Fast Track designation.
...
About Rexista™ Oxycodone XR incorporating PODRAS™
The Company's Rexista™ Oxycodone XR product candidate has been further enhanced with its proprietary PODRAS™ delivery technology intended to reduce the likelihood of oral abuse when more pills than prescribed are swallowed intact. Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
May 21, 2015
Intellipharmaceutics Intends to Accelerate its Rexista(TM) Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA
TORONTO, May 21, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") provided the Company with notification regarding its Investigational New Drug Application ("IND") submission for Rexista™ Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets. The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin™ is demonstrated.
MT, your point is an important one.
And before you say pipeline worth billions, let's figure out how much of ELI200 net sales goes to Elite. And if the percentage is low will it also be low for the next 2-3 ADTs?
Lasers, you are making unwarranted assumptions.
All indications are that the Naltrexone in ALO-02 is leaking thereby causing Nausea and Vomiting.
Generex Announces Collaboration with NHTherapeutics to Utilize RapidMist™
http://www.prnewswire.com/news-releases/generex-announces-collaboration-with-nhtherapeutics-to-utilize-the-rapidmist-buccal-delivery-technology-for-leuprolide-300088429.html
Generex Announces Collaboration with NHTherapeutics to Utilize the RapidMist™ Buccal Delivery Technology for Leuprolide
WORCESTER, Mass. and TORONTO, May 26, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that it has entered into a Memorandum of Understanding with NHTherapeutics, Inc. (www.nhtherapeutics.com; NHT) pursuant to which the companies will co-develop a formulation for the delivery of Leuprolide into the human body via the buccal mucosa using the Generex proprietary RapidMist™ buccal drug delivery system.
The Generex proprietary RapidMist™ drug delivery platform technology administers active pharmaceutical ingredient via aerosolized metered dose spray into the mouth for rapid absorption by the buccal mucosa. The Company's most advanced product in development using RapidMist™ is Generex Oral-lyn™, an insulin spray product for the treatment of diabetes mellitus.
NHTherapeutics holds intellectual property in respect to the dosing regimen and route of administration of Leuprolide and other GnRH agonists for the treatment of hypogonadism and other endocrine disorders.
Pursuant to a fee-for-service arrangement, Generex will develop a RapidMist™ formulation of Leuprolide designed to achieve the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa. Thereafter, Generex will undertake local irritation and stability testing of the formulation.
It is contemplated that, pending the outcome of the RapidMist™ Leuprolide formuation data, Generex will grant to NHT a license for the global commercial exploitation of the product in the field of endocrine disorders in exchange for royalties.
Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. Traditionally, GnRH agonists are used at a high dose to chronically decrease hormonal release. Leuprolide is given by injection and is marketed to treat the symptoms associated with advanced prostate cancer, central precocious puberty (CPP), endometriosis, and anemia. Conversely, NHT intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels. Proof of concept data already exists. "NHT recognizes that the Generex RapidMist™ drug delivery platform and attendant product development experience, together with NHT's expertise in the field of endocrine disorders, creates a unique opportunity to formulate Leuprolide for rapid and effective administration through the buccal mucosa," commented Dr. David Brusegard, Ph.D., the Company's Chief Operating Officer. "Generex is pleased with this new opportunity to expand our RapidMist™ platform technology."
Dr. Aldemar Degroot, M.S., Ph.D., the President & Chief Executive Officer of NHT, stated: "There is a real market need for a compound that can chronically increase hormonal levels, that is safe, can be easily administered, and that does not affect fertility. Unlike existing products that increase hormonal release, NHT's lead product (NH901) is non-scheduled and will not induce supratherapeutic hormonal levels, which can result in severe adverse effects. We look forward to working with Generex to make this product a reality. Its extensive experience with the buccal delivery of peptide drugs along with its RapidMist™ technology combined with our own experience in endocrine disorders and our intellectual property are bound to lead to success."
Dianne Will's response is an embarrassment.
Dear Thomas,
In this instance, I think they are interchangeable.
This is my personal opinion (and I certainly don’t have the expertise as Nasrat in this area):
I personally use priority review. In my opinion, it may be that the FDA traditionally uses the fast track language and the priority review language has come out of the PDUFA Act. With the PDUFA Act, the FDA is mandated to provide a PDUFA date on when a company can expect a decision by the FDA following the acceptance of an NDA application. PDUFA dates for an NDA are normally a 10 month review cycle for a standard review or a six month review for a priority review. I think it comes down to Nasrat using FDA language and I use the PDUFA language.
IPCI recently also used the fast track language. We just did not issue a press release like IPCI did about not needing a Phase III and the fast track status. Obviously, things can change with the FDA.
However, I don’t doubt for a second that we won’t have a six month review. I believe there is too much of a precedent on this issue for the FDA to change course.
Best regards,
Dianne
Intellipharmaceutics (IPCI) Granted FDA Fast Track Designation for Rexista Oxycodone XR Development Program
Intellipharmaceutics International (NASDAQ: IPCI) today announced that the United States Food and Drug Administration ("FDA") has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System ("PODRAS™") and has concluded that it meets the criteria for Fast Track designation.
Zogenix Announces Shareholders Approve Reverse Stock Split
June 18, 2015 16:18 ET | Source: Zogenix, Inc.
SAN DIEGO, June 18, 2015 (GLOBE NEWSWIRE)
...
Upon the effectiveness of the reverse stock split, each eight shares of the Company's issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.001 per share. As a result of the reverse split, there will be approximately 19.2 million shares of common stock issued and outstanding. The reverse stock split will not affect any shareholder's ownership percentage of Zogenix's common shares. The common shares will trade under a new CUSIP number, 98978L 204, effective July 1, 2015.
N2KA, why focus on 4 products?
Nasrat said:
We don’t have to mind or to execute all of them, so when we decide which are the cream of the top, the top two, three or four and focus on these, keeping in mind how much they’re going to cost..
4th Approval 2017.
NASDAQ 2017/2018.
Buyout 2018.
I have to disagree with your assessment on a buy out in 2018. My response to such a date is - WHY BOTHER? If Elite were to arrive at that year and they have hit the Nasdaq, filed and had approved multiple ADFs, increased the number of generics and their sales (however, small), and even reduced R&D costs associated with fewer trials, I would seriously argue they would have a firm capable of achieving the heights suggested by those using the seemingly wildly enthusiastic comparisons to Pharmacyclics and Jazz. Realistically, when there is the potential for their tech platform that would enable multiple filings, the math becomes compelling for continuing on their current path
I think "Priority Review" is the correct term.
Not "Fast Track," which is different. Fast track gets 60 day review for cancer drugs, etc. NH has used this term, I believe, incorrectly. What he actually describes is "Priority Review," which is a 6 month review. ELI-200 qualifies for Priority Review based on FDA letter to NH; however, Priority Review is not offically-granted until after the application has been submitted. Fast Track status can be granted at any time in the process.
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement.
Lasers, can you expound on this language?
http://finance.yahoo.com/news/elite-pharmaceuticals-granted-patent-abuse-143302702.html
Elite Pharmaceuticals Granted New Patent for Abuse Deterrent Technology
NORTHVALE, N.J., June 16, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP) announced today the issuance of U.S. Patent No. 9,056,054 entitled "Abuse-Resistant Oral Dosage Forms"...
...
"We are pleased with this additional patent coverage," stated Nasrat Hakim, President and CEO of Elite. "This patent expands the number of families of patents that have issued in the United States to Elite which cover abuse deterrent technologies."
And there's your answer... four products.
Nasrat Hakim:
...I’ve said this before, I have more than a dozen ideas of our stock that are ready to go into clinical trials and into the market. We don’t have to mind or to execute all of them, so when we decide which are the cream of the top, the top two, three or four and focus on these, keeping in mind how much they’re going to cost..
mts, you are confusing the OxyContin patents
Lasers- I think TEVA may have jumped the gun. I do not think the patent has yet expired but is due too very soon. I think EPIC and eveyone else is waiting for its expiration. No harm in applying to the FDA to use it in a formula. TEVA also did not attempt to make a generic or change the formula enough to make it different from Purdues Oxy. I am sure the FDA cannot wait until this patent has expired. Even for the FDA I think no love is lost with Purdue having really taken advantage of the FDA for so many years and finally putting the FDA in a very awkward spot. I am sure the FDA will have a voice in this matter.
When the new version was introduced, Purdue pulled the original OxyContin off the market. The patent on the new version runs until 2025.
...
"The issue is really about the generic and the availability issue," says Dr. Joe Ross, an assistant professor at the Yale School of Medicine who studies drug and device safety. "Why do they essentially get a patent extension when they had an unsafe drug on the market for many years? Why would the FDA reward them?"
Kayak, great post. You sound like a PharmD!
ELI-202’s Second Pivotal BE
I’ve been hoping someone would explain how the first pivotal could not meet expectations, but how a followup pilot could determine that the next pivotal would pass with flying colors (as NH indicated)...
...
I believe the 9/9/2014 PR directly addresses this concern with the statement “Two formulations were dosed in the pilot study and both formulations demonstrated that a repeat bioequivalence study with 32 subjects or more would be expected to be bioequivalent for the measured parameters.”
The power of a test sometimes, less formally, refers to the probability of rejecting the null when it is not correct... As the power increases, there are decreasing chances of a Type II error (false negative)...
Power analysis can be used to calculate the minimum sample size required so that one can be reasonably likely to detect an effect of a given size. Power analysis can also be used to calculate the minimum effect size that is likely to be detected in a study using a given sample size...
The sample size determines the amount of sampling error inherent in a test result. Other things being equal, effects are harder to detect in smaller samples. Increasing sample size is often the easiest way to boost the statistical power of a test.
Annual Meeting: Wednesday, August 19, 2015
Schedule 14A:
http://archive.fast-edgar.com//20150602/AFZ2S22C222262P2222T2MZ24VCQS2278272/
What's another billion shares among friends?
1. To elect four directors;
2. To conduct an advisory vote on executive compensation;
3. To ratify the appointment of MNP LLP as independent public accountants for the year ending July 31, 2015;
4. To approve an amendment to our Restated Certificate of Incorporation to increase the authorized number of shares of common stock from 1,500,000,000 shares to 2,450,000,000 shares;
5. To approve an amendment to our Restated Certificate of Incorporation to effect, at any time prior to December 31, 2016, a reverse stock split of our common stock at an exchange ratio to be determined and to proportionately reduce the number of shares of the common stock authorized for issuance (the implementation of the reverse stock split, ratio and timing of which will be subject to the discretion of the Board of Directors);
6. To approve the adjournment of the annual meeting, if necessary, to solicit additional proxies to vote in favor of the proposals set forth in Items 4 and 5; and
7. To conduct any other business as may properly come before the annual meeting or any adjournment or postponement thereof.
ADF Wars: Opana Unsafe For Any Need
WeeZuhl read your post a little while back about the crush resistant hard turtle shell ADT turning to a gel and possibly being a contributor to blood clots.
Could you point me to your posting of this again?
Those determined to abuse the drug couldn't foil the anti-snorting mechanism, but they found a way to melt it down and inject it, with the help of larger-gauge needles that could channel the thicker substance into veins.
A MedPage Today/Milwaukee Journal Sentinel analysis of data from the FDA's adverse events reporting system found that blood-clotting disorders tied to Opana have grown in the wake of the new abuse-deterrent formulation.
In the four years before reformulation, there were two cases of blood-clotting disorders with Opana as the primary suspect. But in 2012, there were 53 cases — accounting for some 5% of all adverse event reports where Opana was the primary suspect.
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.
Since hepatitis C can live for two to three weeks on surfaces, people can pass the virus through other drug paraphernalia, not just needles, Zibbell said.
The abuse-deterrent features of Opana may even help pass the virus. When they prepare the drug, addicts may use more cotton balls as filters, water to cook or injections to get high -- all adding up to more opportunities for exposure.
Abuse-deterrent technologies add to the cost of drugs, and some work better than others. For now, the pills remain on the market, and infections caused by their abuse continue.
“We need more research into abuse-deterrent forms of drugs,” Jerome Adams, Indiana’s state health commissioner, said on a call with reporters. “Just because a drug comes in an abuse-deterrent form, it doesn’t automatically make it safe.”
AE37 ASCO DATA 2015
http://www.prnewswire.com/news-releases/generex-provides-data-update-from-ae37-phase-ii-breast-cancer-trial-one-year-post-completion-of-enrollment-300082832.html
Generex Provides Data Update from AE37 Phase II Breast Cancer Trial One Year Post Completion of Enrollment
9:30 AM ET, 05/14/2015 - PR Newswire
WORCESTER, Mass. and TORONTO, May 14, 2015 /PRNewswire/ -- Generex
....updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine .....
....The current analysis was performed on data that was examined one year after the last patient was enrolled into the trial. The ASCO meeting will be held from May 29 to June 2, 2015 in Chicago, IL.
The abstract, entitled 'Final Pre-specified Analysis of the Phase II Trial of the AE37+GM-CSF Vaccine in High Risk Breast Cancer Patients to Prevent Recurrence", by Julia Greene, et al will be presented on May 30 during the Breast Cancer – HER2/ER session. The study reports on the anticipated five year disease free survival in patients enrolled in a controlled, randomized, and single-blinded Phase II trial that completed enrollment in January of 2014. A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer. This latter group represents a patient population of high unmet need. The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.
ADF Wars: They hold summits
Click the link to see the whole program:
http://abusedeterrent.org/Resources/Docs/PC15098_brochure.pdf
ADF Wars: Here Comes Pfizer!
This e-mail from Pfizer just appeared in my inbox. I have previously documented how Pfizer has been working with non-commercial entities, specifically an organization called Rethink Opioids, to re-educate prescribers to think about prescribing an ADF opioid as a "Universal Precaution." The previous e-mails have been from third-parties and have been free of commercial influence. As I predicted, now comes Pfizer with specific details of the agonist-antagonist ADF Embeda.
Nasrat Hakim:
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.
This is a perfect example of what NH was saying. Completely in the background, Pfizer has started to introduce the idea of prescribing only ADF-opioids. Below is the link to Rethink Opioids. It is a very well-done site, evidence-based medicine with nil commercial influence. Play around on the site and see if you can find the section on agonist/antagonist abuse-deterrence. Not easy to find but its there, and I bet in the near future I'll be hearing more from Pfizer on this issue.
MT, you're really stretching it.
I am comparing two top-line HAL data PR's- one that contains NO DATA AT ALL (PTIE) and the other which reports EXCELLENT DATA (ELTP). And your response is how do we know Elite is not lying about their data? If you do not believe a company is truthful in their public releases, you should sell every share you own today.
I'm happy to stand with you in questioning what info is released and when and how. But if you think they're lying in a PR, you should get out of this position today.
ADF Wars: PTIE's Remoxy "passes" HAL study
http://ih.advfn.com/p.php?pid=nmona&article=66823818
This study demonstrated with statistical significance (p<0.0001) that both intact and chewed REMOXY were less "liked" than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High.
On the co-primary endpoint of Drug Liking, scores were significantly lower for intact REMOXY (p<0.0001) and for chewed REMOXY (p<0.0001) compared to IR oxycodone.
On the co-primary endpoint of Drug High, scores were significantly lower for intact REMOXY (p<0.0001) and for chewed REMOXY (p<0.0001) compared to IR oxycodone.
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.
Hedge Fund Song (Row, row, row your boat).
Chomp, Chomp, Chomp the Float,
Merrily Follow the Scheme,
Quietly, Quietly, Quietly, Quietly,
You Own More Shares Than Hakim.
ADF Wars-- Some Hard-Shell ADFs Are Unsafe
http://www.jsonline.com/news/health/more-blood-clotting-disorders-reported-after-abuse-deterrent-opana-introduced-b99494142z1-303197871.html
The blood-clotting disorder has been limited to the abuse-deterrent formulation of Opana, which drug-maker Endo Pharmaceuticals put on the market in early 2012.
That newer version of the drug was intended to be harder to abuse. An outer coating was supposed to make it too hard to crush, so that it couldn't be snorted, and it was supposed to turn into a thick gooey gel if it was dissolved or melted so it couldn't be drawn up into a syringe and injected.
Those determined to abuse the drug couldn't foil the anti-snorting mechanism, but they found a way to melt it down and inject it, with the help of larger-gauge needles that could channel the thicker substance into veins.
A MedPage Today/Milwaukee Journal Sentinel analysis of data from the FDA's adverse events reporting system found that blood-clotting disorders tied to Opana have grown in the wake of the new abuse-deterrent formulation.
In the four years before reformulation, there were two cases of blood-clotting disorders with Opana as the primary suspect. But in 2012, there were 53 cases — accounting for some 5% of all adverse event reports where Opana was the primary suspect.
You are obfuscating, Doc
Average daily vol April 1 to today 1.012M/day
Average daily vol Jan1 to April 1 1.580M/day
Average daily vol for 2014 2.987M/day
You are probably right, dr_lowenstein
who? what hedge fund in its right mind would invest in a penny stock like this? Please tell us who these hedgies are and what hedging strategy they are using because I see ZERO evidence that such activity is occurring here.
Some hedgie keeps chomping up the float!
Why do you think there is very little retail bid support
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.