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Nice to see us trading into the 8's again! :)
Thanks for the welcome but I'm only day trading this today
Hey man can you buy me a bottle? lol :)
Then had a major dip to $2.00 where I took advantage of her :)
Fusion Fuel Receives Notification of IPCEI Approval from European Commission for 630 MW HEVO-Portugal Project
SABUGO, Portugal, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Fusion Fuel (NASDAQ: HTOO) (the “Company”) is pleased to announce that it has received notification from the European Commission that the Company’s HEVO-Portugal project was among 33 selected for approval under the Important Projects of Common European Interest (“IPCEI”) Hy2Infra program. The €650 million, 630 MW project is to be developed in Sines, Portugal, and would produce 62,000 tonnes of green hydrogen per annum. A portion of the green hydrogen is expected to be used in the production of green ammonia and exported from the Port of Sines to the Port of Rotterdam in the Netherlands. The balance would be consumed by industrial customers in the domestic Portuguese market.
The IPCEI approval positions Fusion Fuel and its partners to commence funding negotiations with the relevant government stakeholders, as well as with the European Investment Bank, which has committed to providing financing and advisory support to those projects selected for public funding.
Frederico Figueira de Chaves, CEO of Fusion Fuel, stated, “This is a game changing achievement for Fusion Fuel, solidifying our position amongst the leading companies in the green hydrogen industry. HEVO-Portugal is one of the largest electrolyzer projects approved in the Hy2Infra wave, a testament to the exceptional innovation of our HEVO technology and the strong conviction that Portugal and the European Union have in our ability to successfully deliver this all-important project. This announcement marks the culmination of a journey that we began four years ago, one that we have quietly pushed forward in the background while focusing relentlessly on the execution of our near-term priorities. I would like to take this opportunity to express my profound appreciation to the team for their diligence and determination in helping us reach this watershed moment.”
Pedro Caçorino Dias, Fusion Fuel’s Head of Commercial for Portugal, added, “The HEVO-Portugal project was conceived of not only as the centerpiece of Fusion Fuel’s green hydrogen project portfolio, but also as the most ambitious green hydrogen project in Portugal. Our vision in creating the project was to help establish Sines as the principal green hydrogen hub of Southern Europe and unite two major European ports in advancing the green energy economy, and in doing so, create substantial spillover benefits to both regions and to industries across Europe. While we are still in the very early innings, we are confident that HEVO-Portugal will be instrumental in contributing to the rapid decarbonization of Portugal’s largest industrial hub and, most importantly, in helping catalyze the European green hydrogen economy.”
$.1.80 pre mkt. Great call bro.
$.1.80 pre mkt. Great call bro.
Anytime bro!
I agree! I looked for filings and the last ones I found were in July of last year! Maybe I'm looking in the wrong place?
Easy to find and although greed is good, I'm not greedy enough to get caught in these when they tank. Got my grass hut on the beach in Tahiti being constructed.
AMBO is much better.Alerted you @ 18 cents :)))
Cheap China stock making a kick-ass moon launch
CHINA P&D. Does this Company even exist?????????????????????
INSANITY continues!
I bought some of their Stephen James coffee and it's just the BEST! I think if they advertise it the awareness on the stock could be big. Here is the link for their coffee
https://getsjcoffee.com/
Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis
Newsfile Corp.
Newsfile Corp
Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study
This is a Designated News Release.
Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis. CardiolRx™ is currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis.
"The FDA's decision was based on pre-clinical data combined with initial clinical data from the Company's MAvERIC-Pilot Phase II study," commented Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "This designation reinforces the potential of CardiolRx™ to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity."
The FDA grants ODD to a drug or biological product to prevent, diagnose, or treat a rare disease or conditions that affect fewer than 200,000 people in the United States. ODD provides benefits to sponsors including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations.
MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis. In addition to standard safety assessments, MAvERIC-Pilot is designed to evaluate improvement in objective measures of this rare disease. The primary efficacy endpoint is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Importantly, the study will assess freedom from pericarditis recurrence.
Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than 2 years, and one third are still impacted at 5 years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fati
I'm riding this baby to a different universe!
SoundHound’s stock roars after Nvidia reveals position worth about $3.7 million as of the end of last year
On the China highway!
She is running hard on heavy pre-market volumes!
Beautiful and closed to near HOD!
Rose over 135% after hours! And did it quietly.
Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver
Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for use in general population
Expands Nanox’s offering in AI solutions, marking third product in Nanox AI’s suite of population health solutions to become commercially available
PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
An estimated 24% of U.S. adults are living with MASLD or NAFLDi, a metabolic disease linked to obesity, cardiovascular disease and type 2 diabetes, all of which pose significant public health concerns. Adults with MASLD are not only at risk of developing severe liver complications, such as cirrhosis and metabolic dysfunction-associated steatohepatitis (MASH), but are also at risk of cardiovascular disease, which is the leading cause of death in people living with MASLDii. MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly. As such, early diagnosis of MASLD could benefit patients and the healthcare system.
While AI assessment of medical imaging offers a reliable, non-invasive, large-scale approach to support clinicians in the assessment of hepatic steatosis (fatty liver), it has traditionally been difficult to assess liver attenuation on contrast-enhanced scans – which make up a large proportion of CT scans – limiting the ability of clinicians to detect non-severe cases of MASLDiii. HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
Amidst rising obesity rates, the prevalence of liver-related disease is growing, and the need for an approved treatment for MASH has yet to be met. With several late-stage drug candidates for MASH in development and the availability of GLP-1 drugs for the management of type 2 diabetes and other metabolic diseases, identification of liver steatosis is especially relevant.
"We are proud to offer HealthFLD as the third product of Nanox AI’s suite of cutting-edge, AI-powered population health solutions designed to confront chronic diseases of great public health concern head-on and potentially improve health outcomes,” said Erez Meltzer, Chief Executive Officer of Nanox. “Furthermore, we believe that AI innovative solutions, and specifically HealthFLD, may deliver substantial advantages to the biopharmaceutical industry to streamline the identification of candidates for clinical trials of much-needed therapies for liver diseases including MASH. This regulatory decision solidifies our leadership as a developer of automated AI software medical devices.”
In a retrospective 2023 study of 2,917 patients, published in the American Journal of Roentgenology (AJR), the HealthFLD AI software demonstrated high performance in the detection of at least moderate hepatic steatosis in contrast-enhanced CT scans, with a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU. Medical imaging offers the only reliable noninvasive method for quantifying liver fat. Integrating HealthFLD with widely used standard CT scans offers clinicians the potential to opportunistically screen for liver steatosis and possible signs of MASLD on a population level. “In recent years, automated, deep learning tools have offered an efficient, low-cost tool used to detect diseases in earlier stages,” said Perry J. Pickhardt, MD, of the University of Wisconsin School of Medicine & Public Health, and lead author of the AJR study. “We are now at a watershed moment when metabolic diseases are growing in prevalence and more effective treatment options are becoming available. It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance. The FDA previously cleared HealthCCSng, a solution that detects coronary artery calcium (CAC) that presents a risk for coronary artery disease, and HealthOST, a solution that assesses vertebral compression fractures and bone mineral density to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine (such as osteoporosis).
About Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD), refers to a group of metabolic conditions linked to obesity, cardiovascular disease and type 2 diabetes. An estimated 30% of the adult population globally has MASLD,iv a major risk factor for chronic liver disease and for cardiovascular disease, which is the leading cause of mortality in this patient population.v
About Nanox AI
Nanox AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI technology, Nanox AI helps clinicians extract valuable and actionable clinical insights from routine medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit https://www.nanox.vision/ai.
About Nanox
Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the
Hahahahahaha I love your answer bro! That made my day! :)
Gotta warn you, I have an itchy hairy back. My wife used to scratch it for me but now that we are no longer married I have to rely on my cat.
INSANITY
Thanks for the tip SOUN
Screws loose! You can say that again!
Nice close $1.37 with volume picking up
Nice close $1.37 with volume picking up
Check CCCC message sent you on that thread
Several mega giant institutions filed for over 5% ownership today. That must have scared a few shorts to cover. Still a large % shorts in stock.
Hey PennyPusher, thank you for this info, I went to that 6k filing and the company only has 20 million shares outstanding. Now I have to admit about from what you posted, this stock is grossly undervalued! IMHO. I doubt many know about this baby but it makes sense to just take a position as the China syndrome could be contagious here. I think $5.00 is a fair value here but gimme $3.00 and I'm off to the bank! :)
Still time imo and thanks for letting me know
Notice how some of these China stocks have a delay in taking off with the news? Might be a good move to take a position here and wait to see.
That was some darn good advise Hulk I owe you one!
HOD + 1.53 with nice volume all week!
So this just came out like 1/2 hour ago. Hmmmm. I know that dino kicked ass in this one couple months ago