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GM $ODYY huge news out!!
ODYSSEY HEALTH, INC, SELECTS SYNEOS HEALTH TO SUPPORT INVESTIGATIONAL NEW DRUG APPLICATION FOR TREATMENT OF CONCUSSION
LAS VEGAS, NV / ACCESSWIRE / November 16, 2023 / Odyssey Health, Inc. (OTCQB:ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, has selected Syneos Health®, a leading fully integrated biopharmaceutical solutions organization to support its Investigational New Drug (IND) Application. Odyssey Health is developing a pharmaceutical treatment for mild Traumatic Brain Injury (mTBI), aka concussion.
Odyssey Health's lead drug candidate for concussion, ONP-002 has completed a Phase I safety trial in Australia. Odyssey submitted a pre-IND application to the FDA this summer and received instructive feedback in September. In preparation for IND submission and clinical trials in the US, Odyssey chose Syneos Health for guidance and review of all pre-clinical and clinical data needed for the final IND package and support of the clinical design protocol for the Phase II clinical trial to be conducted in the US. Syneos Health's expertise combined with the Company's familiarity with the drug candidate and nasal delivery technology further helps position the study for success.
Along with other fully integrated biopharmaceutical solution services, Syneos Health brings global regulatory affairs solutions (GRAS), providing end-to-end regulatory support across many indications and regions. The Syneos Health GRAS team will support Odyssey with a regulatory review for the clinical development plans for Odyssey's concussion drug, ONP-002 and novel intranasal device. As a class II drug: device combination Syneos Health will assist Odyssey in getting the needed advice for Phase II/III clinical trial design and implementation from the FDA.
"Odyssey is excited to partner with such a respected group of experts. Syneos Health has been a global leader in clinical trials for decades and has a strong track record working with the FDA. Furthermore, Syneos Health brings a regulatory affairs team that has years of experience with neurological drugs and intranasal devices. We believe that intranasal drug delivery in the acute phase following concussion is critical to dampening brain inflammation and improving patient outcomes," stated Michael Redmond, CEO of Odyssey Health.
$ODYY HUGE NEWS OUT!!
ODYSSEY HEALTH, INC, SELECTS SYNEOS HEALTH TO SUPPORT INVESTIGATIONAL NEW DRUG APPLICATION FOR TREATMENT OF CONCUSSION
LAS VEGAS, NV / ACCESSWIRE / November 16, 2023 / Odyssey Health, Inc. (OTCQB:ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, has selected Syneos Health®, a leading fully integrated biopharmaceutical solutions organization to support its Investigational New Drug (IND) Application. Odyssey Health is developing a pharmaceutical treatment for mild Traumatic Brain Injury (mTBI), aka concussion.
Odyssey Health's lead drug candidate for concussion, ONP-002 has completed a Phase I safety trial in Australia. Odyssey submitted a pre-IND application to the FDA this summer and received instructive feedback in September. In preparation for IND submission and clinical trials in the US, Odyssey chose Syneos Health for guidance and review of all pre-clinical and clinical data needed for the final IND package and support of the clinical design protocol for the Phase II clinical trial to be conducted in the US. Syneos Health's expertise combined with the Company's familiarity with the drug candidate and nasal delivery technology further helps position the study for success.
Along with other fully integrated biopharmaceutical solution services, Syneos Health brings global regulatory affairs solutions (GRAS), providing end-to-end regulatory support across many indications and regions. The Syneos Health GRAS team will support Odyssey with a regulatory review for the clinical development plans for Odyssey's concussion drug, ONP-002 and novel intranasal device. As a class II drug: device combination Syneos Health will assist Odyssey in getting the needed advice for Phase II/III clinical trial design and implementation from the FDA.
"Odyssey is excited to partner with such a respected group of experts. Syneos Health has been a global leader in clinical trials for decades and has a strong track record working with the FDA. Furthermore, Syneos Health brings a regulatory affairs team that has years of experience with neurological drugs and intranasal devices. We believe that intranasal drug delivery in the acute phase following concussion is critical to dampening brain inflammation and improving patient outcomes," stated Michael Redmond, CEO of Odyssey Health.
$ODYY getting 4 for 1. this is a no brainer at .09. Deal valued at .32 lol
ODYY HUGE NEWS
Oragenics to Acquire Odyssey Health’s Neurological Drug Technology Pipeline Including Concussion Drug Candidate
Gains Nasal Delivery Technologies and Expands Product Pipeline
TAMPA, Fla. & LAS VEGAS--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) and Odyssey Health, Inc. (OTCQB: ODYY) (“Odyssey”) announce the signing of a definitive agreement under which Oragenics will acquire Odyssey’s assets related to its proprietary neurological drug therapies and technologies. The assets include drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as Odyssey’s proprietary powder formulation and its nasal delivery device. Odyssey will retain its other assets and operations.
The asset purchase includes cash payments to Odyssey totaling $1.0 million and eight (8) million shares of Oragenics’ Series F Convertible Preferred Stock. The transaction is expected to close in the fourth quarter of 2023, subject to the satisfaction of various closing conditions, including approval of the transaction by Odyssey’s shareholders and approval of the conversion of the Series F Preferred Stock by Oragenics’ shareholders, of which there can be no assurances.
After closing this transaction, certain members of Odyssey management intend to join Oragenics and lead the continued development of Odyssey’s pipeline of neurological drug therapies and technologies. Odyssey’s technologies are expected to allow for easy nasal administration, rapid drug uptake to the brain, no cumbersome cold-chain protocols, and a strong safety profile, which hold potential to improve patient outcomes.
“We believe this strategic transaction could place Oragenics in a prime position to harness our expertise in intranasal administration, propelling us forward in neurological therapeutics. Our rigorous analysis of the underlying science and technologies has illuminated the immense potential of Odyssey’s neurological assets, which could significantly expand our potential reach into a broader market. Concussions have reached epidemic proportions across sports, the military and among the elderly, with more than five million Americans affected annually. Shockingly, there remains no FDA-approved treatment for this condition,” said Kim Murphy, President and Chief Executive Officer of Oragenics. “We are excited by the prospect of addressing some of the world’s most pressing health challenges and evolving our company to enhance the lives of countless individuals.”
Odyssey’s lead concussion asset (ONP-002) is believed to be a first-in-class intranasal drug under development for the treatment of moderate-to-severe concussion in the acute through subacute phases. In preclinical animal studies, the asset demonstrated rapid and broad biodistribution throughout the brain while simultaneously reducing swelling, inflammation, and oxidative stress along with an excellent safety profile. Results from animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms including improved memory and sensory-motor performance, and reduced anxiety. ONP-002 has completed a Phase 1 clinical trial showing it is safe and well tolerated in healthy human subjects. Odyssey and Oragenics are now preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy.
“I look forward to working with Oragenics on further developing our assets,” said Michael Redmond, President and Chief Executive Officer of Odyssey Health. “Our lead drug candidate for treating concussion has performed well in preclinical studies, generating promising efficacy and safety data in animal models. In addition, ONP-002 has completed a Phase 1 clinical study that concluded the drug is safe and well tolerated in humans. A pre-IND package has been submitted to the FDA for a Phase 2 trial and the collaboration with Oragenics allows for the advancement of these important neurological drug candidates.”
About Mild Traumatic Brain Injury (mTBI)
Concussions are an unmet medical need that affect millions worldwide. Repetitive concussions can increase the risk of developing Chronic Traumatic Encephalopathy (CTE) and other neuropsychiatric disorders. It is estimated that 5 million concussions occur in the U.S. annually and that as many as 50% go unreported. The worldwide incidence of concussion is estimated at 69 million. The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027, according to Grandview Research. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.
About ONP-002
ONP-002 is a fully synthetic, non-naturally occurring neurosteroid being developed to treat mTBI (concussion). In preclinical studies, the drug demonstrated equivalent or better neuroprotective effects compared with related neurosteroids. Animal models of concussion showed the drug reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety and motor/sensory performance. Additionally, ONP-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation while restoring proper blood flow.
About Niemann-Pick Type C Disease
Niemann-Pick Type C (NPC) disease is a rare neurodegenerative genetic disorder characterized by the inability of cells to metabolize and properly transport cholesterol and other lipids, leading to the abnormal accumulation in various bodily tissues, including brain tissue. The NPC market is expected to grow from $128 million in 2022 to $188 million in 2031 across the U.S., Germany and U.K.
About Odyssey Health Inc.
Odyssey Health Inc., formerly Odyssey Group International, Inc., is a medical company with a focus on life-enhancing medical solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility and have a substantial market opportunity. For more information, please visit www.odysseyhealthinc.com.
Visit Odyssey' corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About Oragenics
Oragenics, Inc. is a development-stage company focused on nasal delivery of pharmaceutical medications including in neurology and fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and the National Research Council of Canada (NRC) with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics. For more information, please visit www.oragenics.com.
Not a Solicitation
This communication does not constitute an offer to sell or the solicitation of an offer to buy the securities of either Oragenics or Odyssey or the solicitation of any vote or approval. This communication relates to the proposed acquisition of certain assets from Odyssey by Oragenics.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the ability of Odyssey and Oragenics to successfully close their asset purchase agreement; the ability of the Oragenics to timely and successfully achieve the anticipated benefits of acquiring the Odyssey assets; Oragenics’ future performance, business prospects, events and product development plans. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, the following: Oragenics’ ability increase its authorized shares of Common Stock; Oragenics’ ability to obtain a quorum at future shareholders meetings; Oragenics’ ability to obtain its shareholders’ approval for the (a) the increase in Oragenics’ authorized Common Stock from 4,166,666 to 350,000,000 and (b) the conversion of the Series F Preferred Stock into Common Stock; whether or not all of the closing conditions to the Odyssey transaction will be satisfied and otherwise whether Oragenics will be able to successfully close the Odyssey transaction; Oragenics’ ability to obtain necessary funding, non-dilutive or otherwise, for the development of its product candidates, including its vaccine and lantibiotic assets and, if the Odyssey transaction successfully closes, the concussion asset; Oragenics’ ability to advance the development of its vaccine candidate and lantibiotics candidate (and, if the Odyssey transaction successfully closes, the concussion asset) under the timelines and in accord with the milestones it projects; the regulatory application process, research and development stages, and future clinical data and analysis relating to vaccines and lantibiotics, including any meetings, decisions by regulatory authorities, such as the FDA and Canadian regulatory authorities and investigational review boards, whether favorable or unfavorable; the potential application of Oragenics’ vaccine candidate to variants and other coronaviruses; Oragenics’ ability to obtain, maintain and enforce necessary patent and other intellectual property protection and license agreements; the nature of competition and development relating to COVID-19 immunization and therapeutic treatments and demand for vaccines and antibiotics; Oragenics’ and/or Odyssey’s expectations as to the outcome of preclinical studies, nasal administration, transmission, manufacturing, storage and distribution; other potential adverse impacts such as delays in regulatory review, manufacturing delays and supply chain issues, adverse impacts on healthcare systems and disruption of the global economy; the ability to sustain compliance with Oragenics’ exchange listing requirements; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20231004015689r1&sid=acqr8&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20231004015689/en/
Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com
Odyssey Health, Inc.
info@odysseyhealthinc.com
LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com
Source: Oragenics, Inc.
© Copyright Business Wire 2023
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Odyssey Group International Inc (PK)
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HUGE NEWS
Oragenics to Acquire Odyssey Health’s Neurological Drug Technology Pipeline Including Concussion Drug Candidate
Gains Nasal Delivery Technologies and Expands Product Pipeline
TAMPA, Fla. & LAS VEGAS--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) and Odyssey Health, Inc. (OTCQB: ODYY) (“Odyssey”) announce the signing of a definitive agreement under which Oragenics will acquire Odyssey’s assets related to its proprietary neurological drug therapies and technologies. The assets include drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as Odyssey’s proprietary powder formulation and its nasal delivery device. Odyssey will retain its other assets and operations.
The asset purchase includes cash payments to Odyssey totaling $1.0 million and eight (8) million shares of Oragenics’ Series F Convertible Preferred Stock. The transaction is expected to close in the fourth quarter of 2023, subject to the satisfaction of various closing conditions, including approval of the transaction by Odyssey’s shareholders and approval of the conversion of the Series F Preferred Stock by Oragenics’ shareholders, of which there can be no assurances.
After closing this transaction, certain members of Odyssey management intend to join Oragenics and lead the continued development of Odyssey’s pipeline of neurological drug therapies and technologies. Odyssey’s technologies are expected to allow for easy nasal administration, rapid drug uptake to the brain, no cumbersome cold-chain protocols, and a strong safety profile, which hold potential to improve patient outcomes.
“We believe this strategic transaction could place Oragenics in a prime position to harness our expertise in intranasal administration, propelling us forward in neurological therapeutics. Our rigorous analysis of the underlying science and technologies has illuminated the immense potential of Odyssey’s neurological assets, which could significantly expand our potential reach into a broader market. Concussions have reached epidemic proportions across sports, the military and among the elderly, with more than five million Americans affected annually. Shockingly, there remains no FDA-approved treatment for this condition,” said Kim Murphy, President and Chief Executive Officer of Oragenics. “We are excited by the prospect of addressing some of the world’s most pressing health challenges and evolving our company to enhance the lives of countless individuals.”
Odyssey’s lead concussion asset (ONP-002) is believed to be a first-in-class intranasal drug under development for the treatment of moderate-to-severe concussion in the acute through subacute phases. In preclinical animal studies, the asset demonstrated rapid and broad biodistribution throughout the brain while simultaneously reducing swelling, inflammation, and oxidative stress along with an excellent safety profile. Results from animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms including improved memory and sensory-motor performance, and reduced anxiety. ONP-002 has completed a Phase 1 clinical trial showing it is safe and well tolerated in healthy human subjects. Odyssey and Oragenics are now preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy.
“I look forward to working with Oragenics on further developing our assets,” said Michael Redmond, President and Chief Executive Officer of Odyssey Health. “Our lead drug candidate for treating concussion has performed well in preclinical studies, generating promising efficacy and safety data in animal models. In addition, ONP-002 has completed a Phase 1 clinical study that concluded the drug is safe and well tolerated in humans. A pre-IND package has been submitted to the FDA for a Phase 2 trial and the collaboration with Oragenics allows for the advancement of these important neurological drug candidates.”
About Mild Traumatic Brain Injury (mTBI)
Concussions are an unmet medical need that affect millions worldwide. Repetitive concussions can increase the risk of developing Chronic Traumatic Encephalopathy (CTE) and other neuropsychiatric disorders. It is estimated that 5 million concussions occur in the U.S. annually and that as many as 50% go unreported. The worldwide incidence of concussion is estimated at 69 million. The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027, according to Grandview Research. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.
About ONP-002
ONP-002 is a fully synthetic, non-naturally occurring neurosteroid being developed to treat mTBI (concussion). In preclinical studies, the drug demonstrated equivalent or better neuroprotective effects compared with related neurosteroids. Animal models of concussion showed the drug reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety and motor/sensory performance. Additionally, ONP-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation while restoring proper blood flow.
About Niemann-Pick Type C Disease
Niemann-Pick Type C (NPC) disease is a rare neurodegenerative genetic disorder characterized by the inability of cells to metabolize and properly transport cholesterol and other lipids, leading to the abnormal accumulation in various bodily tissues, including brain tissue. The NPC market is expected to grow from $128 million in 2022 to $188 million in 2031 across the U.S., Germany and U.K.
About Odyssey Health Inc.
Odyssey Health Inc., formerly Odyssey Group International, Inc., is a medical company with a focus on life-enhancing medical solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility and have a substantial market opportunity. For more information, please visit www.odysseyhealthinc.com.
Visit Odyssey' corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About Oragenics
Oragenics, Inc. is a development-stage company focused on nasal delivery of pharmaceutical medications including in neurology and fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and the National Research Council of Canada (NRC) with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics. For more information, please visit www.oragenics.com.
Not a Solicitation
This communication does not constitute an offer to sell or the solicitation of an offer to buy the securities of either Oragenics or Odyssey or the solicitation of any vote or approval. This communication relates to the proposed acquisition of certain assets from Odyssey by Oragenics.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the ability of Odyssey and Oragenics to successfully close their asset purchase agreement; the ability of the Oragenics to timely and successfully achieve the anticipated benefits of acquiring the Odyssey assets; Oragenics’ future performance, business prospects, events and product development plans. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, the following: Oragenics’ ability increase its authorized shares of Common Stock; Oragenics’ ability to obtain a quorum at future shareholders meetings; Oragenics’ ability to obtain its shareholders’ approval for the (a) the increase in Oragenics’ authorized Common Stock from 4,166,666 to 350,000,000 and (b) the conversion of the Series F Preferred Stock into Common Stock; whether or not all of the closing conditions to the Odyssey transaction will be satisfied and otherwise whether Oragenics will be able to successfully close the Odyssey transaction; Oragenics’ ability to obtain necessary funding, non-dilutive or otherwise, for the development of its product candidates, including its vaccine and lantibiotic assets and, if the Odyssey transaction successfully closes, the concussion asset; Oragenics’ ability to advance the development of its vaccine candidate and lantibiotics candidate (and, if the Odyssey transaction successfully closes, the concussion asset) under the timelines and in accord with the milestones it projects; the regulatory application process, research and development stages, and future clinical data and analysis relating to vaccines and lantibiotics, including any meetings, decisions by regulatory authorities, such as the FDA and Canadian regulatory authorities and investigational review boards, whether favorable or unfavorable; the potential application of Oragenics’ vaccine candidate to variants and other coronaviruses; Oragenics’ ability to obtain, maintain and enforce necessary patent and other intellectual property protection and license agreements; the nature of competition and development relating to COVID-19 immunization and therapeutic treatments and demand for vaccines and antibiotics; Oragenics’ and/or Odyssey’s expectations as to the outcome of preclinical studies, nasal administration, transmission, manufacturing, storage and distribution; other potential adverse impacts such as delays in regulatory review, manufacturing delays and supply chain issues, adverse impacts on healthcare systems and disruption of the global economy; the ability to sustain compliance with Oragenics’ exchange listing requirements; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20231004015689r1&sid=acqr8&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20231004015689/en/
Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com
Odyssey Health, Inc.
info@odysseyhealthinc.com
LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com
Source: Oragenics, Inc.
© Copyright Business Wire 2023
Back to News Headlines
Other Financial Information
Recent News & Disclosure Filings
Recent SEC Filings
OTCQB Venture Market Logo
OTCQB Member Since 10/2023
OTCQB
Verified Profile IconVerified Profile 07/2023
Transfer Agent Verified IconTransfer Agent Verified
Independent Directors IconIndependent Directors
Seems there's still buyers showing up!!$ODYY
News out!! Maybe this is why they cancelled. $ODYY
ODYSSEY HEALTH, INC. PRESENTS CONCUSSION TREATMENT DATA AT THE MILITARY HEALTH SYSTEM RESEARCH SYMPOSIUM - MHSRS
LAS VEGAS, NV / ACCESSWIRE / August 23, 2023 / Odyssey Health, Inc. (OTC:ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, recently presented at the Military Health System Research Symposium (MHSRS). Odyssey is developing a novel pharmaceutical, ONP-002, to be given intranasally for brain-targeted delivery in the acute through subacute period following mild traumatic brain injury (mTBI) also known as a concussion. MHSRS requested presentation submissions and after review, selected the Odyssey ONP-002 technology to be presented in poster-style at its yearly conference.
The scientific poster included: 1) the use of a heat stable spray-dried powdered formulation to eliminate the need for burdensome cold chain controls in the field, 2) the development of a breath-propelled intranasal device that enhances drug dispersion depth and conformity, 3) preclinical data in animals showing that ONP-002 treatment improves memory and neuromotor function while reducing depressive-like behavior after mTBI, and 4) positive safety and pharmacokinetic findings in Odyssey's recently completed Phase I clinical trial.
The MHSRS was held August 14th-17th and provided an opportunity for military and civilian medical providers, academia, and industry from around the world to meet and discuss ideas for improving military healthcare. Areas like Comprehensive Strategy and Action Plan for Warfighter Brain Health, Precision Medicine Research: Optimizing Warfighter Healthcare, Readiness, and Return to Duty, and Battlefield Biomarkers for TBI: Diagnostic and Prognostic Indicators were discussed at the Scientific Assembly.
Far-forward missions conducted by military forces require fast and effective field solutions to improve military readiness and prevent late and long-term consequences of brain trauma. Odyssey's poster presentation, "A Novel Intranasal Pharmaceutical for Treatment of Mild Traumatic Brain Injury in the Field," focused on the advantages of developing a lightweight intranasal field-deliverable drug-device combination for concussion management in the early phases following injury.
Cabo not just any device, it's an FDA Clinically approved with a payment code from Medicare/Medicaid. Let's see where this all goes, including the Phase II with the concussion drug. JMHO GLTY
Here you go Cabo
ODYSSEY HEALTH, INC. PRESENTS DATA AT THE SPECIAL OPERATIONS MEDICAL ASSOCIATION - SCIENTIFIC ASSEMBLY
LAS VEGAS, NV / ACCESSWIRE / June 8, 2023 / Odyssey Health, Inc. (OTCQB:ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, recently presented at the Special Operations Medical Association (SOMA) - Scientific Assembly. Odyssey is developing a novel pharmaceutical, ONP-002 to be given intranasally for brain-targeted delivery in the acute through subacute period following mild traumatic brain injury (mTBI) aka concussion. SOMA requested presentation submissions and after review, they selected the Odyssey ONP-002 technology to be presented in poster-style at its yearly conference.
SOMA's Scientific Assembly held in Raleigh, NC May 15 -19 provided an opportunity for military and civilian medical providers, academia, and industry from around the world to meet and discuss ideas for improving active military healthcare. Areas like Prolonged Field Care, Tactical Combat Casualty Care, and Acute Resuscitative and Surgical Care were discussed at the Scientific Assembly.
Odyssey's poster presentation "A Novel Intranasal Pharmaceutical for Treatment of Mild Traumatic Brain Injury in the Field." focused on the advantages of developing a lightweight intranasal field-deliverable drug-device combination for concussion management in the early phases following injury.
Far-forward missions conducted by special operation forces require fast and effective field solutions to improve military readiness, this aligns with ONP-002 development goals. Topics in the scientific poster related to the Odyssey drug development program included:
Heat stable spray-dried formulation eliminating cold chain controls
Breath-propelled intranasal device enhancing drug dispersion depth and conformity
Preclinical data improving memory and neuromotor function while reducing depressive-like behavior
Positive safety and pharmacokinetic findings in Phase I trials
looks like some positive news this morning Cabo!! $ODYY
I'm still here Cabo and will be picking more up next week.Been away traveling but i'm back. I think once the Phase II trials start (if they haven't already) this is going to pop. $ODYY
Cabo you have your days confused i bid for them on Monday and didn't get an, and got filled Tuesday. Here you go
04/18/2023 9:44:44 EDT 0.095 3000 OTCBB
04/18/2023 9:43:58 EDT 0.10 1889 OTCBB
04/18/2023 9:40:53 EDT 0.095 7000 OTCBB
04/18/2023 9:38:00 EDT 0.095 10000 OTCBB
04/18/2023 9:36:03 EDT 0.095 10000 OTCBB
LOL that was posted yesterday. no worries...
Tuesday, April 18, 2023 9:59:50 AM
Post# of 303 Go
Had a bid for 50k yesterday @.09 but didn't get any. Thanks to the peep for giving me the 30k @.095 this morning smile $ODYY!!!
Nope waiting for them to Start Phase 2. LOL i bought those yesterday not today. I have noticed that anytime size is put up on the bid, the offer rises. Thinking more of a short than a seller...JMHO $ODYY
Had a bid for 50k yesterday @.09 but didn't get any. Thanks to the peep for giving me the 30k @.095 this morning $ODYY!!!
Cabo what do you have left? I'll gladly take it from you $ODYY
Great lotto ticket to have-:) $ODYY
That lottery ticket might look even better
UPDATE 1-U.S. FDA clears Abbott's blood test for concussions
Tue, March 7, 2023, 9:30 AM EST
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March 7 (Reuters) - The U.S. Food and Drug Administration has cleared Abbott Laboratories' blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday.
The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI.
TBIs are caused by blow or whiplash to the head and can pose risk of short- and long-term effects that can include impairment of memory and movement.
Abbott already has a plasma test for TBI and was cleared by the FDA in 2021.
The new test measures two indicators in the blood that, in elevated concentrations, are tightly correlated to brain injury, the company said. (Reporting by Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber)
Absolutely, and it may even before they announce Phase 2 :-}
No you're not the only one
Historical Short Volume Data for ODYY
Date Close High Low Volume Short Volume % of Vol Shorted
Feb 02 NA NA NA 460,750 232,200 50.40
Feb 01 NA NA NA 15,100 12,500 82.78
Jan 31 NA NA NA 114,771 97,850 85.26
Jan 30 NA NA NA 59,563 20,610 34.60
Jan 27 NA NA NA 86,850 33,360 38.41
Jan 26 NA NA NA 45,877 13,500 29.43
Jan 25 NA NA NA 151,107 41,156 27.24
Jan 24 NA NA NA 108,820 43,305 39.80
Jan 23 NA NA NA 100,772 56,106 55.68
Jan 20 NA NA NA 48,716 7,668 15.74
Jan 19 NA NA NA 88,613 27,613 31.16
Jan 18 NA NA NA 239,207 137,999 57.69
Jan 17 NA NA NA 49,645 7,000 14.10
Jan 13 NA NA NA 112,543 33,110 29.42
Jan 12 NA NA NA 110,701 58,551 52.89
Jan 11 NA NA NA 46,386 31,262 67.40
Jan 10 NA NA NA 49,317 22,318 45.25
Jan 09 NA NA NA 26,249 750 2.86
Jan 06 NA NA NA 70,991 33,446 47.11
Jan 05 NA NA NA 39,429 19,030 48.26
Jan 04 NA NA NA 75,922 37,850 49.85
From todays news states credit line of $10 million!!
ODYSSEY HEALTH, INC. PROVIDES UPDATE ON COMPANY AND THE PROGRESS OF CONCUSSION DRUG DEVELOPMENT
Las Vegas, Nevada, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today presents a Company update and recap of its concussion drug development program. Concussions represent an ‘unmet’ medical need and affect tens of millions worldwide.
Odyssey acquired the intellectual property and all rights to the concussion drug in March 2021. Since the acquisition, Odyssey has added key industry experts to its management, made significant progress in the drug development program, and completed a Phase I human clinical trial. Key successes include:
Adding two key executives to the management team that have pertinent pharmaceutical experience bringing drugs through the clinical process and to the market.
Completion of FDA-required IND enabling studies for a Phase I human trial. This work was performed in partnership with multiple GMP/GLP third party vendors.
Development of a nanoparticle spray-dried formulation for intranasal delivery to enhance brain uptake. This work was performed in partnership with our UK partner under GMP regulations.
Development and GMP manufacture of our novel breath-propelled intranasal delivery device with our California based engineering partner.
Patent application filed for our novel breath-propelled intranasal delivery device.
Contracted with world-class contract research organizations, Avance Clinical Pty, Ltd. and Nucleus Networks to conduct the Phase I clinical trial.
Excellent compliance of our breath-propelled intranasal delivery device in the Phase I trial.
Completion of the Phase I human clinical trial, proving the drug is safe and well tolerated.
Phase I human clinical trial showed no drug accumulation through the 10-day patient follow-up visit.
Ongoing drug stability at elevated temperatures showing no degradation
Raised over $5 million to support the company and its development efforts and access to an equity line with Lincoln Park Capital for up to $10 million.
Cabo their reporting insinuates that ODYY was the recipient of TANF funds. That is patently false. Next the drug passed Phase 1. If the drug wasn't pliable, they wouldn't be allowed into Phase 2 Human trials, that is factual info! Their false and misleading lies are hurting our value and we have damages!!JMHO
I'm also consulting with an Attorney today in NYC about a class-action suit for shareholders against ESPN, NBC and Phalanx. They can't get away with publishing false and misleading stories!!
LOL I did listen to the "analyst" report. He states the Company has "no money"! He obviously didn't do his fact checking either! It's in their filings that they have an $8,000,000.00 LOC from Lincoln Park with approx $7.9 MILLION left as of last filing!!! I think ODYY should sue them all for their LIES!!!
Favre and Prevacus have NOTHING to do with ODYY! ODYY acquired the drug from Prevacus FACT!! NBC and ESPN didn't do any "fact checking" before running their story. We know it's not FDA approved, that's why they're moving into Phase 2 studies!! Look at the company filings ie FORM 3 and 4's, due you see Brett Favre's name?? He's not the "biggest shareholder " as the media is reporting. Totally false story. JMHOand keeping with the FACTS!!
Favre and the Company Prevacus have NOTHING to do with ODYY. ODYY acquired the drug from Prevacus. NBC and ESPN didn't do any "fact checking" before running their story. they have a "hard on " for Brett Favre!! As far as efficacy, that's why they're in clinical trials. When Phase 2 is complete i'll bet they will change their tune...I'm sticking to the facts JMHO
I wouldn't know. I'm sure it will be disclosed in the next 10Q. Like what i'm seeing $ODYY
$ODYY Expanding the team!!!
Odyssey Health Inc. Strengthens Commitment to Odyssey NeuroPharma Through Expansion of Executive Team
Las Vegas, Nevada, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc. (the "Company" or "Odyssey"), a medical technology company focused on developing unique, life-saving medical products, is pleased to announce its continued commitment to the newly formed entity, Odyssey NeuroPharma, with the expansion of its executive team.
Joining the executive team at Odyssey NeuroPharma to advance Odyssey’s concussion treatment, and Niemann-Pick treatment, is Erik Emerson as Chief Commercial Officer and Greg Gironda as Chief Operating Officer. Mr. Emerson and Mr. Gironda have over 50 years of collective pharmaceutical experience in commercializing innovative pharmaceutical compounds with leading pharmaceutical companies.
“Odyssey NeuroPharma is dedicated to addressing the unmet medical needs in traumatic brain injury. Erik and Greg will provide the proven experience and expertise needed to bring this novel treatment through clinical trials and ultimately to commercial launch,” said Michael Redmond, CEO of Odyssey Health.
“The team at Odyssey is committed to bringing solutions to a devastating but poorly understood issue. The opportunity to impact the lives of our military, elderly, children, and athletes was something that one can only hope for in our careers.” Mr. Erik Emerson continued, “mild traumatic brain injury and the subsequent long-term effects are a true urgency. Joining the team at this critical juncture to lead our conversion of strong early science, to potential patient availability is unique.
Concussions effect all segments of our society, with over 5 million occurrences annually in the U.S. alone. Currently, there are no FDA approved treatments available. Odyssey Neuropharma is planning a Phase II program, which will evaluate efficacy in support of its extensive safety and animal data.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in life-saving medical products and solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The Company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the Company’s website at www.odysseyhealthinc.com
We encourage our shareholders to visit our corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About Odyssey NeuroPharma Inc.
Odyssey NeuroPharma, Inc., is a wholly-owned subsidiary of Odyssey Health Inc. and focused on developing drugs to treat neurological disorders. The blood-brain barrier (“BBB”) represents a significant obstacle for drug delivery to the brain. Many drugs have failed in neuroscience research due to the inability to jump the hurdle that is the BBB. The Odyssey NeuroPharma will use its unique intranasal delivery device coupled with its powdered formulations to let drugs be delivered more directly to the brain, providing for efficient and quick delivery. This targeted approach requires less drug to accomplish neuroprotection further reducing drug levels in the plasma which reduces side effects.
Forward-Looking Statements
This news release may have forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements because of various factors and uncertainties, including our ability to continue to raise needed funds, complete the Phase II trial, our ability to develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
https://www.globenewswire.com/newsroom/ti?nf=ODY4ODM5NSM1MjQxNDg0IzUwMDA4NjI2NA==
https://ml.globenewswire.com/media/ZGE4YjRlNzktYzdjMC00ZDU3LWJjZGItNjc3ZTRkODQ3ZThmLTUwMDA4NjI2NA==/tiny/Odyssey-Health-Inc.png
$ODYY NEWS OUT!!
Odyssey Health Inc. Files Full US Patent Application on Novel Breath-Propelled Intranasal Brain-Drug Delivery Device
Las Vegas, Nevada, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc. (the "Company" or "Odyssey"), announces that it has filed for United States and global patent protection on its novel breath-propelled, intranasal brain-drug delivery device (“Nasal Device”). As announced, Odyssey’s recently completed Phase I study to treat concussion successfully used Odyssey’s Nasal Device and drug combination.
Odyssey designed the Nasal Device with a novel drug dispensing system that creates an effective airflow for depositing concentrated drug deep into the nasal cavity and onto the olfactory region for quick and direct diffusion into the brain to treat central nervous system (“CNS”) injury, disease or disorder.
The Phase I study used Odyssey’s novel Nasal Device to deliver Odyssey’s concussion drug, PRV-002, and to determine the safety of its PRV-002 concussion drug. The PRV-002 concussion drug-Nasal Device combination was well-tolerated in forty (40) healthy human volunteers. The study documented no Nasal Device failures.
“We were very pleased with the functionality and performance of the Nasal Device during the Phase I study and its administration of Odyssey’s PRV-002 concussion drug. The ability to get drugs for neurological conditions delivered directly into the brain rapidly at effective levels while simultaneously having less concern for side effects is a huge advantage in the development of safe and efficacious treatments. Odyssey’s novel Nasal device provides that opportunity and advantage,” commented Michael Redmond, CEO of Odyssey.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in life-saving medical products and solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company’s website at www.odysseyhealthinc.com
We encourage our shareholders to visit our corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About PRV-002
PRV-002 is a synthetic non-naturally occurring neurosteroid being developed to treat central nervous system (“CNS”) injury, disease or disorder, such as, traumatic brain injury (“TBI”), especially mTBI (concussion). In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete the Phase I trial, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
https://www.globenewswire.com/newsroom/ti?nf=ODY4NTcyMyM1MjMzNjY2IzUwMDA4NjI2NA==
https://ml.globenewswire.com/media/MDllZmU1M2QtOWRmZS00NTcyLWIyYTgtOTQ2NGQ2ZjhmYTEzLTUwMDA4NjI2NA==/tiny/Odyssey-Health-Inc.png
Source: Odyssey Health, Inc
$ODYY NEWS OUT!!
Odyssey Health Inc. Files Full US Patent Application on Novel Breath-Propelled Intranasal Brain-Drug Delivery Device
Las Vegas, Nevada, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc. (the "Company" or "Odyssey"), announces that it has filed for United States and global patent protection on its novel breath-propelled, intranasal brain-drug delivery device (“Nasal Device”). As announced, Odyssey’s recently completed Phase I study to treat concussion successfully used Odyssey’s Nasal Device and drug combination.
Odyssey designed the Nasal Device with a novel drug dispensing system that creates an effective airflow for depositing concentrated drug deep into the nasal cavity and onto the olfactory region for quick and direct diffusion into the brain to treat central nervous system (“CNS”) injury, disease or disorder.
The Phase I study used Odyssey’s novel Nasal Device to deliver Odyssey’s concussion drug, PRV-002, and to determine the safety of its PRV-002 concussion drug. The PRV-002 concussion drug-Nasal Device combination was well-tolerated in forty (40) healthy human volunteers. The study documented no Nasal Device failures.
“We were very pleased with the functionality and performance of the Nasal Device during the Phase I study and its administration of Odyssey’s PRV-002 concussion drug. The ability to get drugs for neurological conditions delivered directly into the brain rapidly at effective levels while simultaneously having less concern for side effects is a huge advantage in the development of safe and efficacious treatments. Odyssey’s novel Nasal device provides that opportunity and advantage,” commented Michael Redmond, CEO of Odyssey.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in life-saving medical products and solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company’s website at www.odysseyhealthinc.com
We encourage our shareholders to visit our corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About PRV-002
PRV-002 is a synthetic non-naturally occurring neurosteroid being developed to treat central nervous system (“CNS”) injury, disease or disorder, such as, traumatic brain injury (“TBI”), especially mTBI (concussion). In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete the Phase I trial, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
https://www.globenewswire.com/newsroom/ti?nf=ODY4NTcyMyM1MjMzNjY2IzUwMDA4NjI2NA==
https://ml.globenewswire.com/media/MDllZmU1M2QtOWRmZS00NTcyLWIyYTgtOTQ2NGQ2ZjhmYTEzLTUwMDA4NjI2NA==/tiny/Odyssey-Health-Inc.png
Source: Odyssey Health, Inc
Cabo we already know the drug is safe and well tolerated based on the Phase 1 findings. Can't wait for Phase 2!! $ODYY
Cabo also this went from a stock that didn't trade at all to one that trades a few hundred thousand a day. So i like what i'm seeing $ODYY
They did with Laidlaw, as per their filings. But that was at .35. Why would they be selling down here? Again i'm not worried...
Cabo looking a little better right now. lets see how the week plays out $ODYY
Don't worry it will be back. Just a matter time. $ODYY all the way!!!
keep in mind that a lot of shares traded between .15-.20 weeks ago. i'm sure there was a lot of churning when it popped (peeps doubling profit). I believe we're creating new lower base JMHO. More importantly I like what I see!! $ODYY
$ODYY Train is leaving the station!!All aboard!!
$ODYY keeps chugging!! All aboard!!!
$ODYY train is plugging along!!