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nice work...hog
$IPCI..bounced off that 2.74 and looking strong going into the last hour...hog
$IPCI my table pounder...Intellipharmaceutics Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent Re...
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Intellipharmaceutics International Inc. (MM) (NASDAQ:IPCI)
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Today : Monday 30 March 2015
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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 provided an update on the progress of the product development programs for both its Rexista™ Oxycodone Abuse Deterrent oxycodone hydrochloride extended release tablets and for its Regabatin™ XR once-daily, non-generic extended release version of pregabalin.
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.
The Company recently submitted an Investigational New Drug Application ("IND") to the United States Food and Drug Administration ("FDA") for Rexista™ 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™ Oxycodone XR in individuals with chronic low back pain.
Intellipharmaceutics has recently conducted and analyzed the results of three definitive open label, blinded, randomized, crossover, Phase I pharmacokinetic clinical trials in which Rexista™ Oxycodone XR was compared to Oxycontin™ under single dose fasting, single dose steady-state fasting and single dose fed conditions in healthy volunteers. Intellipharmaceutics has received topline data results from all three studies. The first study, a single dose steady-state fasting study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 94.95 percent (90 percent confidence interval of 81.29 to 110.89 percent) and on the measure of area under the curve steady state (AUCss) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 100.54 percent (90 percent confidence interval of 89.97 to 112.34 percent).
The second study, a single dose fasting study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 92.69 percent (90 percent confidence interval of 80.26 to 107.04 percent), on the measure of area under the curve time (AUCt) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 100.53 percent (90 percent confidence interval of 95.13 to 106.53 percent) while on the measure of area under the curve infinity (AUCinf) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 114.87 percent (90 percent confidence interval of 108.21 to 121.93 percent).
The third study, a single dose fed study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 91.66 percent (90 percent confidence interval of 80.21 to 104.75 percent), on the measure of area under the curve time (AUCt) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 103.21 percent (90 percent confidence interval of 94.15 to 113.15 percent) while on the measure of area under the curve infinity (AUCinf) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 107.39 percent (90 percent confidence interval of 98.62 to 107.39 percent).
Regabatin™ XR
The Company also reported that the FDA has accepted a Pre-Investigational New Drug (Pre-IND) meeting request for its once-a-day Regabatin™ XR non-generic controlled release version of pregabalin under the new drug application ("NDA") 505(b)(2) regulatory pathway, with a view to possible commercialization in the United States at some time following the December 30, 2018 expiry of the patent covering the pregabalin molecule. Regabatin™ XR is based on the Company's controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromylagia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing.
Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. A once-a-day controlled release version of pregabalin should reduce the number of doses patients currently take, potentially improving patient compliance, and thereby potentially improving clinical outcomes. This Pre-IND request with the FDA is focused on the Company's proposed Phase III clinical program.
There can be no assurance that additional clinical trials will meet our expectations, that we will have sufficient capital to conduct such trials, that we will be successful in submitting any NDA with the FDA, that the FDA will approve these product candidates for sale in the U.S. market, or that they will ever be successfully commercialized.
"We are excited with the positive topline data results of the Phase I studies utilizing formulations and dosages of our Rexista™ Oxycodone XR product candidate, and we look forward to the FDA's guidance on our IND filing on Rexista™ Oxycodone XR, and on our Pre-IND submission for Regabatin™," stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "We believe that our abuse deterrent technology has the potential to positively differentiate Rexista™ from other abuse deterrent technologies of which we are aware, and that it represents an important step towards helping patients manage their pain safely. For both Rexista™ and Regabatin™, we plan to move forward, subject to FDA guidance, into Phase III trials. We also plan to explore potential strategic business development relationships for these novel product candidates."
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths which received final FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Applications filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has NDA 505(b)(2) product candidates in its development pipeline. These include Rexista™ Oxycodone XR, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical OverDose Resistance Activating System, and Regabatin™ XR pregabalin extended-release capsules.
Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," "intends," "could," or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches, the seasonal fluctuation in the numbers of prescriptions written for our dexmethylphenidate hydrochloride extended-release capsules which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers' facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact:
Intellipharmaceutics International Inc.
Domenic Della Penna
Chief Financial Officer
416-798-3001 ext. 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
Intellipharmaceutics International Inc. Logo
BNHLF...yep quietly rising...hog
NVIV...InVivo Therapeutics Announces University of Kansas Medical Center as New Site for Neuro-Spinal Scaffold Clinical Trial
Date : 03/30/2015 @ 8:00AM
Source : Business Wire
Stock : Invivo Therapeutics Holdings Corp (QB) (NVIV)
Quote : 2.81 0.0 (0.00%) @ 7:40AM
InVivo Therapeutics Announces University of Kansas Medical Center as New Site for Neuro-Spinal Scaffold Clinical Trial
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InVivo Therapeutics Holdings (USOTC:NVIV)
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Today : Monday 30 March 2015
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InVivo Therapeutics Holdings Corp. (NVIV) today announced that the University of Kansas Medical Center in Kansas City, KS has been added as a clinical site in the company’s ongoing Investigational Device Exemption (IDE) pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Paul Arnold, MD, Professor of Neurosurgery and Vice Chair of Research, has been named Principal Investigator at the site.
“We look forward to participating in this exciting pilot study of an innovative device that is targeted at addressing the huge unmet medical need in the treatment of acute spinal cord injury patients,” Dr. Arnold said.
Mark Perrin, InVivo’s CEO and Chairman, said, “We welcome Dr. Arnold and University of Kansas Medical Center into InVivo’s ongoing pilot study, which was recently reopened for concurrent enrollment of the final three patients. We are pleased to be working with a researcher of Dr. Arnold’s caliber, and are pleased as well that we now have nine sites open to enroll subjects.”
InVivo’s first patient was enrolled in October 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, AZ. In January 2015, InVivo announced enrollment of its second patient in the study at Carolinas Medical Center in Charlotte, NC.
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the U.S. Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and acts as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect" and similar expressions, and include statements regarding the company’s ability to conduct a pivotal study. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
IPCI.. NEWS: Intellipharmaceutics Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent Re...
Date : 03/30/2015 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Intellipharmaceutics International Inc. (MM) (IPCI)
Quote : 2.7168 0.0 (0.00%) @ 7:58AM
Intellipharmaceutics Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent Re...
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Intellipharmaceutics International Inc. (MM) (NASDAQ:IPCI)
Intraday Stock Chart
Today : Monday 30 March 2015
Click Here for more Intellipharmaceutics International Inc. (MM) Charts.
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 provided an update on the progress of the product development programs for both its Rexista™ Oxycodone Abuse Deterrent oxycodone hydrochloride extended release tablets and for its Regabatin™ XR once-daily, non-generic extended release version of pregabalin.
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.
The Company recently submitted an Investigational New Drug Application ("IND") to the United States Food and Drug Administration ("FDA") for Rexista™ 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™ Oxycodone XR in individuals with chronic low back pain.
Intellipharmaceutics has recently conducted and analyzed the results of three definitive open label, blinded, randomized, crossover, Phase I pharmacokinetic clinical trials in which Rexista™ Oxycodone XR was compared to Oxycontin™ under single dose fasting, single dose steady-state fasting and single dose fed conditions in healthy volunteers. Intellipharmaceutics has received topline data results from all three studies. The first study, a single dose steady-state fasting study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 94.95 percent (90 percent confidence interval of 81.29 to 110.89 percent) and on the measure of area under the curve steady state (AUCss) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 100.54 percent (90 percent confidence interval of 89.97 to 112.34 percent).
The second study, a single dose fasting study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 92.69 percent (90 percent confidence interval of 80.26 to 107.04 percent), on the measure of area under the curve time (AUCt) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 100.53 percent (90 percent confidence interval of 95.13 to 106.53 percent) while on the measure of area under the curve infinity (AUCinf) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 114.87 percent (90 percent confidence interval of 108.21 to 121.93 percent).
The third study, a single dose fed study, showed that Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 91.66 percent (90 percent confidence interval of 80.21 to 104.75 percent), on the measure of area under the curve time (AUCt) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 103.21 percent (90 percent confidence interval of 94.15 to 113.15 percent) while on the measure of area under the curve infinity (AUCinf) the ratio of Rexista™ Oxycodone XR to Oxycontin® was 107.39 percent (90 percent confidence interval of 98.62 to 107.39 percent).
Regabatin™ XR
The Company also reported that the FDA has accepted a Pre-Investigational New Drug (Pre-IND) meeting request for its once-a-day Regabatin™ XR non-generic controlled release version of pregabalin under the new drug application ("NDA") 505(b)(2) regulatory pathway, with a view to possible commercialization in the United States at some time following the December 30, 2018 expiry of the patent covering the pregabalin molecule. Regabatin™ XR is based on the Company's controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromylagia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing.
Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. A once-a-day controlled release version of pregabalin should reduce the number of doses patients currently take, potentially improving patient compliance, and thereby potentially improving clinical outcomes. This Pre-IND request with the FDA is focused on the Company's proposed Phase III clinical program.
There can be no assurance that additional clinical trials will meet our expectations, that we will have sufficient capital to conduct such trials, that we will be successful in submitting any NDA with the FDA, that the FDA will approve these product candidates for sale in the U.S. market, or that they will ever be successfully commercialized.
"We are excited with the positive topline data results of the Phase I studies utilizing formulations and dosages of our Rexista™ Oxycodone XR product candidate, and we look forward to the FDA's guidance on our IND filing on Rexista™ Oxycodone XR, and on our Pre-IND submission for Regabatin™," stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "We believe that our abuse deterrent technology has the potential to positively differentiate Rexista™ from other abuse deterrent technologies of which we are aware, and that it represents an important step towards helping patients manage their pain safely. For both Rexista™ and Regabatin™, we plan to move forward, subject to FDA guidance, into Phase III trials. We also plan to explore potential strategic business development relationships for these novel product candidates."
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths which received final FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Applications filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has NDA 505(b)(2) product candidates in its development pipeline. These include Rexista™ Oxycodone XR, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical OverDose Resistance Activating System, and Regabatin™ XR pregabalin extended-release capsules.
Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," "intends," "could," or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches, the seasonal fluctuation in the numbers of prescriptions written for our dexmethylphenidate hydrochloride extended-release capsules which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers' facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact:
Intellipharmaceutics International Inc.
Domenic Della Penna
Chief Financial Officer
416-798-3001 ext. 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
Intellipharmaceutics International Inc. Logo
$ATHX...Athersys: An Ischemic Stroke Holy Grail? Find Out In Less Than A Month
http://seekingalpha.com/article/3022366-athersys-an-ischemic-stroke-holy-grail-find-out-in-less-than-a-month
NVIV...getting out of the OTC...that is what we want and that is what NVIV is delivering...add to it the news that we know is coming and these prices are gifts..nice trade today hound...hog
nice dawg...woooopigsoooie
back in at 0.53...hog
i picked some up at 2.72...hog
wish some would get freaky...i will be there to add to my already overweighted position...hog
thank you rhodey..always watching you guys...it would be a three peat and things always come in threes...good luck to the longs...hog
http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
CEO’s Perspective
Reverse Splits and Uplisting
We view uplisting to NASDAQ — one of our corporate goals for 2015 — as an important and positive step in InVivo’s long-term growth strategy. One of the quantitative requirements for initial listing is that the closing price of our stock must be above $3.00 for 5 days. Properly executing our planned reverse stock split allows us to fulfill this crucial price requirement and reap the benefits of being on NASDAQ.
Ultimately, we believe the uplisting and higher stock price resulting from the reverse stock split will make our stock more attractive to a broader investor base. Currently, many institutional investors cannot invest in our company for a number of restrictive reasons, including our lower stock price, our trading on an OTC market, and related volatility. Furthermore, we will be in a better position to attract Wall Street analysts to cover our company’s progress with a higher stock price. The inherent increase in visibility associated with analyst coverage can also translate to greater liquidity for our shareholders.
Companies execute a reverse stock split for one of two primary reasons. It is important to discuss the distinction and motivation behind the two routes to fully appreciate what drives market perception of this action.
Reverse Stock Split by Companies to Avoid Delisting
Companies already listed on a major national exchange (NASDAQ or NYSE) must abide by a strict set of rules in order to maintain a listing. One such rule is a minimum price requirement; companies that have fallen under the threshold risk losing their listed status. These companies tend to be viewed as underperforming (as evidenced by their low stock price) and execute a reverse stock split simply to maintain their listing. In this case, the split is used to avoid the negative market perception of losing their listing.
Over 50% of reverse stock splits executed between 2010 and 2013 were in response to stock exchange deficiency notices, so it is no surprise that there is generally a negative market perception of a reverse stock split for this purpose.
Reverse Stock Split by Growing Companies to Gain a Listing
In comparison to companies executing a reverse stock split to maintain a listing, companies that execute a reverse stock split in order to uplist often have an upward trajectory. Such companies can often deliver positive stock price performance post-split as they take an important step in their growth. Other key attributes of companies that conduct successful splits and uplistings include having sufficient cash to reach near-term milestones, consistent news flow, and a commitment to transparency in communicating company goals with investors. InVivo intends to follow this trajectory.
In selecting the 1-for-4 reverse stock split ratio, we decided on a target price above
$10, which is an important psychological threshold for stocks. We evaluated previously executed reverse splits associated with an uplisting and found that 1-for-4 reverse splits priced in the $10 range generally performed well post-split.
We look forward to reporting to you on our anticipated success following our reverse stock split and planned uplisting and thank you for your ongoing support and confidence.
Mark Perrin, CEO and Chairman
March 24, 2015
Not all RS' are created equal...NVIV is doing this with the intention of uplisting and getting bigger players involved...they are speeding up the clock...all good imo...hog
Looking good over here...hog
Lol...but how much fun....bob prolly runs a looser ship....looking forward to the next nascar posts...hog
i was waiting for the pics...lol
from investor alley...may have already been posted..
2 Biotech Stocks under $10 to Scoop up Now
BRET JENSEN MARCH 15, 2015
IntelliPharmaCeutics International Inc. (NASDAQ: IPCI) recently popped up on my radar due to a couple of positive analyst mentions. IntelliPharmaceutics is an emerging biopharmaceutical company based in Canada. The shares currently go for just under $2.50. Within the last month or so Brean Capital reiterated its “Buy” rating and $8.00 a share price target. Maxim Group did the same albeit with a $7.00 a share price target. Both of these came from highly ranked analysts within the biotech and biopharma space.
The company is engaged in the research, development, and commercialization of controlled-release and targeted pharmaceutical products. The company’s proprietary Hypermatrix™ allows for the intelligent and efficient design of drugs through the precise control of a number of key variables.
The FDA recently approved the company’s generic version of the marketed drug Focalin XR® which has three-quarters of a billion dollars in annual sales. The drug will be distributed by IntelliPharmaCeutics partner Par Pharmaceutical Inc. The company has a half dozen other reformulated generic versions of drugs before the FDA through its Abbreviated New Drug Application filing process and the company is willing to take on a partner like Par Pharmaceutical for distribution.
In late summer, the company announced an enhancement to its Rexista abuse-deterrent technology. The new platform is called Podras (Paradoxical OverDose Reistance Activating Platform). The new platform potentially restricts the amount of active drug released in the body if more pills are consumed than prescribed while preserving the normal release of the drug if the amount consumed is as expected. Rexista technology prevents drug tampering while Podras addresses all forms of prescription drug misuse/abuse.
The most promising product being developed using this new technology combination is a generic oxycodone candidate. It’s an abuse-resistant version of this widely used drug with $2.3 billion in annual sales just in the United States. Given the company’s pipeline, myriad shots on goal, analyst support and minuscule $55 million market capitalization the stock is worth a small speculative position.
Although the small cap biotech and biopharma areas are inherently volatile spaces, I find both of these plays attractive from a risk/reward perspective at current levels.
Urgent: Back-Door Access to a $3.35 Billion Market Opportunity. Bret’s latest pick has found a legal method to circumvent the standard FDA approval process, meaning it’s products come to market faster and it’s R&D costs are significantly lower. It’s already up 156% since he first initiated coverage. NOW it’s set to grow as much as 2,715.13%! Click here to check out your next potential 10-bagger.
.http://www.investorsalley.com/2-biotech-stocks-under-10-to-scoop-up-now/
$CUR...nice strong close...hog
$IPCI...great day today...up over 14%...i posted a chart this morning...hog
ok guys...i know what is different here...
i posted this...
Post # of 4267
i dont have the energy to respond to this...lol
bigcat2 Member Level Friday, 03/20/15 01:40:42 PM
Re: north40000 post# 86870
Post # of 86872
NVIV - Be careful
If I remember correctly I heard these same stories 2 years ago when the stock ran from 1.50 ish to around 6.. But then it tanked to 50 cents.
I'd be interested to know why this time is different. Seems and looks like the same pattern with same data to me.
then Dane posted this...
TheDane Member Profile TheDane Member Level Friday, March 20, 2015 1:50:44 PM
Re: hogfan2 post# 4260 Post # of 4267
Where did it come from?
Respond | View Replies (1)
i then posted where it came from...
hogfan2 Member Level Friday, March 20, 2015 1:52:34 PM
Re: TheDane post# 4261 Post # of 4267
on sheffs board...investorshub.advfn.com/$heffs-$tation-of-$tocks-&-$olid-DD-9413/
Respond | View Replies (1)
since then i have been getting posts telling me why now is different...from the beginning i stated i dont have the enegry to respond to the post....NVIV has so many catalysts and has accomplished so much that i didnt have the energy to do justice to the huge opportunity NVIV has given us...so please no more pms or posts telling me that NVIV is a different company...i am completely aware and have made a considerable amt of money here and we are just beginning in my opinion...hope everyone has a fantastic weekend...hog
ron...not sure what you mean..i have been here a long time and have loaded the proverbial boat...lol...this is changing my zip code
yep...no worries...hog
agreed...buy Share on the ask and make my portfolio look better...lol
i dont have the energy to respond to this...lol
bigcat2 Member Level Friday, 03/20/15 01:40:42 PM
Re: north40000 post# 86870
Post # of 86872
NVIV - Be careful
If I remember correctly I heard these same stories 2 years ago when the stock ran from 1.50 ish to around 6.. But then it tanked to 50 cents.
I'd be interested to know why this time is different. Seems and looks like the same pattern with same data to me.
BIAD.. 0.2401 x 0.2729 ... 7900 x 15000.. damn
IPCI...best volume in quite awhile...hog
$IPCI...HOD on volume...wooopigsooie...hog
$SGYP...nice play...i kept meaning to look at this but never got around to it...hog
$NVIV..very nice news...we were trading above 3 before this information and 3 more pts can be enrolled any day and NVIV will be providing updates soon as well as stated in there last pr...hog
NVIV...Jesi has confirmed it...So besides my move back to inpatient rehab I have some pretty exciting news! I moved my leg on my own! They say my hip flexors are reactivating! Whoop
Whoop moving this process along!!
-Jesi
(Thank you Yara for updating my other sites)
http://www.gofundme.com/lm00m0
NVIV...HOD but wont be the only HOD we see today...hog
NVIV...going to go nutso...hog