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True Synergy: Marijuana use may up pre-diabetes risk
http://indianexpress.com/article/lifestyle/health/marijuana-use-may-up-pre-diabetes-risk-study/
I told you! Stoner dogs get the munchies! I was all wrong before- Fletcher is a true visionary genius! BUCCAL CANNABIS--> BUCCAL INSULIN. Synergy!
Unfortunately, JJ, I cannot agree.
Someone may figure it out quickly... but I think not likely they will.
It more than likely will be a very expensive process with expensive equipment the common street pusher either wont understand or wont be able to afford.
If Elite could not do it without great expense and the HAL contractor could not do it just using common everyday household
ingredients I highly doubt anyone will be able to crack this without great time effort and expense..... thus making the whole
point moot.
rdfdr1, don't get caught in straw man arguments
Why can't the junkie simulate stomach acid?
There are several rather serious errors in that analysis.
First, one must look at the totality of the abuse deterrent data for Targiniq. The best source of this is the FDA approved package insert.
https://www.google.com/?gws_rd=ssl#q=targiniq+pi
Second it is a serious error to do cross study comparisons and arrive at such strong conclusion, alas a problem all to often seen in these sort of debates
You are correct, Doctor, but miss the point.
As you know, the half life of naloxone or naltrexone is largely irrelevant as these substances only come into play when abuse is undertaken and then the half life of such is not the same as the GI half life of the drugs if taken via oral administration. Further, as you know, in the case of Targiniq, the bioavailability after oral administration of noloxone is negligible, ie less than 2% by design.
Of course the beads can be separated!
Honestly, I feel pretty terrible about it. Ever since I first published my plan for an Aerodynamic Separation Machine, this stock has been completely stuck in the mud. As we all know, ELTP 2 bead pharma-based ADF cannot be chewed, crushed, snorted, charred, smoked, or injected; and the 2 beads cannot be separated by color, size, weight, or density. However, the bead system can be defeated by a diabolical international conspiracy of highly-engineered, finely-tuned, industrial equipment designed to separate the beads based on slight differences in aerodynamic resistance.
I hereby pledge, as of today, that I will not engage in any such conspiracy to design and build my world network of Aerodynamic Separation Machines, for at least 10 years from now. Please mark this post. Any upward movement of this stock through the end of the year should certainly be attributed to this post.
There may be more there, JJ.
Patients who snorted the ELI-200 thought they were snorting the placebo. Nice.
My favorite R&R slide.
Shows Mean Drug Liking on Visiual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) is actually *disliked* at the outset- see how the blue line falls below the placebos (red & yellow). For some reason, drug abusers disliked snorting it, as opposed to feeling neutral, like snorting the placebo. And ELI-200 never bumps above the placebo line, indicating the naltrexone effect is long-lasting. (I'm looking at you, alleged-ADF Targiniq, with your short half-life naloxone instead of longer half-life naltrexone.) A great data slide. Thanks Nasrat!
New Embeda e-mail from Pfizer: still plugging away
The link goes here, nice ADF info on Embeda:
https://www1.pfizerpro.com/hcp/embeda/clinical-abuse/overview?source=EM_HAL_LearnMore&cbn=1-435411451:1-435411476&tpn=2709587
Id like to know who has been buying all the shares in gnbt lately
"the first tranche of funding..."
Wha? Generex received funding but there's no mention of millions of GNBT shares given in exchange. I'm very confused about this alternative funding method, but I like it.
Generex Announces Commencement of Buccal Leuprolide R&D Work
9:30 AM ET, 09/08/2015 - PR Newswire
Collaboration with NHTherapeutics has begun
WORCESTER, Mass. and TORONTO, Sept. 8, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today announced that research and development work on buccal Leuprolide has begun. The Company previously announced a Memorandum of Understanding with NHTherapeutics, Inc. (www.nhtherapeutics.com) 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 platform technologies.
Generex has received from NHTherapeutics the first tranche of funding under the Memorandum of Understanding as well as the initial shipment of Leuprolide. The Generex RapidMist™ R&D protocols have been initiated, the goal of which is to achieve a formulation for the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa, after which local irritation and stability testing will be undertaken.
The companies' intention is that, upon successful completion of the R&D work, Generex will grant to NHTherapeutics 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. NHTherapeutics intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels.
I know your area well, Dr. Pete.
I'm a Bearcat! Graduate of Univ of Cincinnati College of Medicine. Lived in Northside/Cumminsville neighborhood for 4 years. Great city. I know of that Killen Generator, too. A notorious polluter, as are all those coal-fired plants along the Ohio River.
And yes, for opioid-naive patients, OxyIR 15mg is a lot of oxy! And giving it around the clock for 48 hours should be very effective, if not downright sedating. I feel bad for the placebo arm! They get nothing but sugar.
All the assumptions are that the news will be awesome but if it is bad news no one can sell fast enough.
The study is designed to evaluate the safety and efficacy of oxycodone/naltrexone 1.5 mg and 3.0 mg versus placebo. During the blinded phase of the study(inpatient portion) the dosing regimen is 1 capsule containing 15 mg Oxycodone Hydrochloride with 1.5 mg Naltrexone Hydrochloride or 3.0 mg Naltrexone Hydrochloride, or placebo taken with 4 to 6 ounces (oz) of water every 6 hours (q6h) for 48 hours following the first dose (Multiple-dose Period) while in-house. Then for the open-label phase of the study (outpatient portion) dosing will occur every 4 to 6 hours prn with 15 mg Oxycodone/1.5 mg Naltrexone. The active and placebo study medications will appear identical.
Don't forget to sell whatever you bought...
OK if it starts at a higher price I'll put in about .02 to .03 higher and it'll get filled
Stoner Dogs Get The Munchies, Indeed
BUCCAL CANNABIS--> Doritos & grape pop-->BUCCAL INSULIN-->REPEAT
GNBT a weed stock? Avoid the undesirable aspects of inhalation and unpredictable results of oral ingestion. Just don't mix up the weed puffer and the insulin puffer. Buccal absorption works, folks. Only question is if management can execute before the lights go out.
http://www.prnewswire.com/news-releases/generex-announces-formalization-of-buccal-cannabis-co-development-plan-300136673.html
Generex Announces Formalization of Buccal Cannabis Co-Development Plan
Contract signed with CannScience Innovations Inc.
WORCESTER, Mass. and TORONTO, Sept. 2, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that its previously announced intention to implement a buccal cannabis co-development arrangement with CannScience Innovations Inc. (www.cannsci.com) has been formalized.
Generex and CannScience have entered into a binding Co-Development and Technology Licensing Agreement. Pursuant to the Agreement, Generex has licensed its proprietary RapidMist™ drug delivery platform technologies to CannScience for the co-development of products for the buccal delivery of cannabinoids and cannabinoid-derived products and granted an exclusive license to CannScience for the commercialization of such products in Canada in exchange for royalty payments. Generex and CannScience will co-own the intellectual property created by this co-development effort and will share profits from the global commercialization of the products.
CannScience is a research & development biopharmaceutical company established to conduct research, and undertake the development of, therapeutic products based on the extracts from medicinal cannabis. The company is developing proprietary technologies and owns know-how related to the chemistry and pharmacology of medicinal cannabis. CannScience is working on integrating various medical devices and drug delivery technologies for the delivery of medications for various patient populations.
"With this co-development program, Generex and CannScience seek to benefit from the growing global trend towards legalization of cannabis, particularly for medicinal purposes," commented Mark Fletcher, Generex President & Chief Executive Officer. "Our goal here is to develop products combining proprietary formulations and devices for the buccal delivery of dose-specific cannabinoids into the human body with no deposit into the lungs, thereby offering a safe, simple, fast, and efficacious alternative to smoking or edibles with their attendant uncertainties in respect of onset of action and dose control."
all of these on a fully diluted basis.
FORM 10-Q
(Quarterly Report)
Filed 02/14/14 for the Period Ending 12/31/13
...
Authorized 690,000,000 shares
The google machine never lies.
http://seekingalpha.com/article/2029611-elite-pharmaceuticals-ceo-discusses-f3q2014-results-earnings-call-transcript
February 18, 2014
Carter Ward
They conducted a thorough study with lengthy interviews and due diligence. And then they finally issued a 30 page report which confirmed our opinion. The report shows a conservative valuation, a most likely valuation and a best case valuation. And I can tell you the conservative valuation was $0.40, most likely was $2.10 and the best case valuation was $2.75, all of these on a fully diluted basis.
So that’s $0.40, $2.10 and $2.75 and that’s not future value, that’s the present value today. Future value will be more. Now these valuations are based on the Elite executing its’ strategic plan and we’re on schedule as you can tell by our financials.
I call it fraud!
Valuation was indeed hype to dilute at higher pps
Two Rexistas? Unpossible!
Yes it's confirmed that there's going to be 2 versions of Rexista...the 1st one which has already been fast tracked is the original potential best-in-class version incorporating their npodds tech...which IPCI is currently doing the bioequivalence on for submission to the FDA most likely during Q1 2016 which will be the 7 to 9 month mark from when they received the go ahead from the FDA to skip phase III entirely.
I think the better question to ask IPCI is if they are developing two different Rexista formulations. For the sake of differentiation, let’s refer to them as Rexista Legacy and Rexista PODRAS. Rexista Legacy is a mechanical barrier ADF 12 hour oxycodone formula with successful Phase 1 results and is likely undergoing Human Abuse Liabilty studies at this time. The company says it has been informed by FDA that Rexista Legacy may be able to skip Phase 3 and therefore will be ready for NDA submission within 6-12 months. The company would use revenue from FDA-approved Rexista Legacy as a non-dilutive source of funding to research and develop Rexista PODRAS, an augmented formulation of Rexista Legacy in which preclinical studies suggest it could possibly reduce oral abuse and may prevent oral overdose. Due to this unique characteristic, Rexista PODRAS fulfills an unmet medical need and was granted Fast Track status by FDA.
We have a pulse! Breath damnit BREATH!!
http://www.prnewswire.com/news-releases/generex-provides-update-on-success-of-buccal-insulin-formulation-enhancement-project-300132713.html
Generex Provides Update on Success of Buccal Insulin Formulation Enhancement Project
WORCESTER, Mass. and TORONTO, Aug. 25, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today provided an update on the status of the buccal insulin formulation enhancement project for the Company's proprietary Generex Oral-lyn™ buccal insulin spray product. As previously announced, Generex engaged the University of Toronto's Center for Molecular Design and Pre-formulations (CMDP) (www.cmdp.uhnres.utoronto.ca) through the University Health Network (www.uhn.ca) with the goal of enhancing the Generex Oral-lyn™ formulation to make it more attractive to patients and prospective commercialization partners by increasing the bioavailability of insulin in the product and reducing the number of sprays required to achieve effective prandial metabolic control for patients with diabetes.
...
Dr. Brusegard commented: "We are pleased to report that our preliminary efforts have succeeded in increasing the insulin concentration in the product by approximately 400 to 500 percent as confirmed by a variety of in vitro testing procedures while preserving the solubility, stability, and biologic activity and potency of the insulin in the formulation."
...
In the dogs given the enhanced Generex Oral-lyn™ formulation, there was a 9-fold increase in serum insulin at 15 minutes (excluding one dog who had little response) and almost 500% greater absorption of insulin over the two-hour test period compared to dogs given the original formulation. There was a 33% decrease in serum glucose at 30 minutes in dogs treated with the enhanced Generex Oral-lyn™ formulation, compared to a 12% increase in serum glucose in dogs treated with the original formulation.
"The outstanding results of these dog studies coupled with the positive findings from the in vitro work provide support and confidence to move forward as quickly as possible with the remaining clinical and regulatory work necessary to achieve FDA approval of the enhanced Generex Oral-lyn™ formulation," said Dr. Anderson.
Generex Oral-lyn™ is designed to be a safe, simple, fast, flexible, and effective alternative to prandial insulin injections in people with either type 1 or type 2 diabetes mellitus.
I agree that elite MAY gain market share in the acute pain market IF their tech is any good at all, however, I do not see the ultimate leap into the chronic pain market.
I agree that elite MAY gain market share in the acute pain market IF their tech is any good at all
...however, I do not see the ultimate leap into the chronic pain market. For once, there is the convenience issue, if you could take a once or twice a day product vs three times a day, the preference in every market research study is for the more convenient dosage form..
But, the larger issue is that off label use in the opioid market is rapidly changing. The FDA is unlikely to approve promotion without chronic use clinical data (a two year program)...
the DEA tracks how these drugs are being prescribed and seeing scripts for long term use of products approved for acute pain only is s big red flag, and more importantly, the payors are very unlikely to pay for off label use in this field.
So, elite, MAY have a nice little product here, but that is about it .
From the Way-Back Machine:
April 5, 2015:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112417780
Rebuttal: “The Big Money Is In Extended-Release”
.....
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.
How many opioids have ADF labeling?
Immediate Release Opioids Are >91% ALL Opioid Prescriptions
And in just a few more months there will be just one company with an FDA-Approved, ADF-labeled immediate-release opioid. ELI-200 is a true best-in-class product utilizing ELTP 2 bead pharma-based ADF. It cannot be chewed, crushed, snorted, dissolved, or injected. Recreational drug users hated it.
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I may be mis-remembering, but...
I have other Biotechs that were presenters @ R&R and it did SQUAT for the share $ of the stock !
Agree 100%.
Why would we ever consider allowing drugco's to promote off-label uses of their drugs? If they believe their drug is effective for a particular indication then they need to do the proper study to prove it. That is the driving force behind what I do all day every day-- evidence-based medicine. If they can't do the study, then it's just snake oil.
GI Joe with Kung Fu Grip?
That would be okay. Also, an Official Red Ryder Carbine-Action Two-Hundred-Shot Range Model Air Rifle. But you better buy those shares back soon, expecting Phase 3 results "later this year," as in next month.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115786826
7/29/15:
NH will want to have a little sparkle for Rodman & Renshaw. I say Phase 3 results released in the week before R&R (Sept 8-10, 2015).
Don't forget European venture with ELI-154 a 24 hr ER non-ADF oxy.
Elite can easily leave out Eli 216 and hand them something rather special.
Merger with Epic = Bad, Bad, Bad
Would mean Epic owners enjoying the majority of Elite's future revenues (even more so than what they already own via the Strategic Alliance). Current Epic revenues dwarf current Elite revenues, but Elite growth potential far outpaces Epic growth potential. Why would we merge now and dilute into Epic to get to Nasdaq instead of growing organically with ADF's?
Not to mention that the deal would be hammered out by two incestuous BOD's and an Elite CEO with a secret interest in Epic. Bad, bad, bad.
Epic= #1 risk to my Elite investment, hands down.
Nothing ever showed up on Charles Schwab.
When will IPCI stop pretending...
...that Rexista with PODRAS will skip Phase 3 and be ready for submission in 6-12 months???
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115888966
I think the better question to ask IPCI is if they are developing two different Rexista formulations. For the sake of differentiation, let’s refer to them as Rexista Legacy and Rexista PODRAS. Rexista Legacy is a mechanical barrier ADF 12 hour oxycodone formula with successful Phase 1 results and is likely undergoing Human Abuse Liabilty studies at this time. The company says it has been informed by FDA that Rexista Legacy may be able to skip Phase 3 and therefore will be ready for NDA submission within 6-12 months. The company would use revenue from FDA-approved Rexista Legacy as a non-dilutive source of funding to research and develop Rexista PODRAS, an augmented formulation of Rexista Legacy in which preclinical studies suggest it could possibly reduce oral abuse and may prevent oral overdose. Due to this unique characteristic, Rexista PODRAS fulfills an unmet medical need and was granted Fast Track status by FDA.
Seeking Alpha: All subjects enrolled and dosed in Elite Pharma's late-stage trial of abuse-deterrent opioid
http://seekingalpha.com/news/2684335-all-subjects-enrolled-and-dosed-in-elite-pharmas-late-stage-trial-of-abuse-deterrent-opioid?uprof=45#email_link
Aug 3 2015, 10:12 ET | About: Elite Pharmaceuticals,... (ELTP) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
163 patients have been enrolled and dosed in a Phase 3 study assessing Elite Pharmaceuticals' (OTCQB:ELTP -0.8%) abuse-deterrent opioid, ELI-200, for the treatment of severe post-surgical pain. Top-line data are expected by year end.ELI-200's abuse-deterrent technology, called ART, is a multi-particulate capsule that contains the opioid antagonist naltrexone. When taken as intended, the naltrexone passes through the body unreleased while the opioid agonist is released over time to relieve pain. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the opioid-associated euphoria.
BondsSF: A better question to ask the company.
I think the better question to ask IPCI is if they are developing two different Rexista formulations. For the sake of differentiation, let’s refer to them as Rexista Legacy and Rexista PODRAS. Rexista Legacy is a mechanical barrier ADF 12 hour oxycodone formula with successful Phase 1 results and is likely undergoing Human Abuse Liabilty studies at this time. The company says it has been informed by FDA that Rexista Legacy may be able to skip Phase 3 and therefore will be ready for NDA submission within 6-12 months. The company would use revenue from FDA-approved Rexista Legacy as a non-dilutive source of funding to research and develop Rexista PODRAS, an augmented formulation of Rexista Legacy in which preclinical studies suggest it could possibly reduce oral abuse and may prevent oral overdose. Due to this unique characteristic, Rexista PODRAS fulfills an unmet medical need and was granted Fast Track status by FDA.
In my opinion, Rexista Legacy may be producing revenue within 12-18 months, and those revenues will be used to develop Rexista PODRAS. For whatever reason, the company has not been forthright about the two different Rexista development programs. If they used my terminology, the recent PR's would read as below (obviously, edits in red are added by me).
August 28, 2014
Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Novel Overdose Deterrence Technology
Preclinical studies of Rexista™ (PODRAS) suggest that, unlike other third-party abuse-deterrent oxycodone products, 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, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
Rexista™ (Legacy) Oxycodone XR
The Company recently submitted an Investigational New Drug Application ("IND") to the United States Food and Drug Administration ("FDA") for Rexista™ (Legacy) Oxycodone XR in anticipation of the commencement of Phase III clinical trials. Planning has begun for the Phase III trials that will examine the efficacy and safety of Rexista™ (Legacy) Oxycodone XR in individuals with chronic low back pain.
The Company believes the FDA notification is significant as it provides a basis for an accelerated development plan for its Rexista™ (Legacy) Oxycodone XR product candidate, without the need for more costly and time-consuming Phase III studies. The Company intends to file a New Drug Application ("NDA") for Rexista™ (Legacy) Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets with the FDA within the next 6 to 12 months, although no assurance to this effect can be given. Further, there can be no assurance that the FDA will ultimately approve the NDA for sale of Rexista™ (Legacy) Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
In March 2015, the Company requested Fast Track designation for its novel, and potentially first-in-class, Rexista™ (PODRAS) Oxycodone XR abuse deterrent oxycodone hydrochloride extended release tablets incorporating its PODRAS™ technology platform. A basis for the request was that Rexista™ (PODRAS) Oxycodone XR has the potential to address an unmet medical need, namely the prevention, deterrence or reduction of the abuse of oxycodone HCl extended release solid oral dosage forms involving the deliberate or inadvertent oral ingestion of more intact pills or tablets than prescribed to achieve a feeling of euphoria. This is a very common and serious form of drug abuse.
Great Article on HAL Studies (short)
http://www.ft.com/cms/s/0/1476db54-359c-11e5-bdbb-35e55cbae175.html#ixzz3hLRubfld
July 29, 2015 6:03 pm
Wanted: recreational drug users with a nose for business
David Crow in New York
The drug users are recruited by research clinics on behalf of the pharma companies, housed in special accommodation, and paid between $250 and $300 a day for the trials, which can last up to a month.
There are only a handful of centres in North America equipped to conduct the trials, and they are in many cases running at full capacity. Lifetree Clinical Research in Salt Lake City, Utah, has seen the number of participants enrolled in its drug-liking studies jump from 267 in 2012 to 677 last year, according to figures seen by the Financial Times. Lifetree has been contracted to run studies involving 582 participants so far this year.
“There’s been a lot of volume around abuse-deterrence,” said Beatrice Setnik, a vice-president at INC.
I agree with Mazeppa about everything.
Including this:
Assuming (reasonably) that ELTP entered the data as they received it, they had the programs pre-written with the methodologies to test the data for significance. Right now, likely in the "clean up" phase--impute missing data if necessary, double check, write up. With an n=161, this is going to be quick to buzz through.