Cardiol Therapeutics Inc (CRDL)

[barnyarddog]

FDA Approves Landmark COVID/Heart/CBD Clinical Trial

September 30, 2020
https://biotechstocktrader.com/fda-approves-landmark-covid-heart-cbd-clinical-trial/

[barnyarddog]

September 25, 2020 Cardiol Therapeutics Receives FDA Approval for Investigational New Drug (IND) Application for Phase II/III COVID-19 Trial

Trial will take place at major U.S. centers and examine the cardioprotective properties of CardiolRx™ in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease (CVD)

https://www.cardiolrx.com/cardiol-therapeutics-receives-fda-approval-for-investigational-new-drug-ind-application-for-phase-ii-iii-covid-19-trial/

[barnyarddog]

https://www.cardiolrx.com/investors/press-releases/

[barnyarddog]

CardiolRx is a cannabidiol formulation being developed for the treatment of inflammatory cardiovascular conditions.

https://www.cardiolrx.com/products/cardiolrx-cbd/

[barnyarddog]

Cardiol Therapeutics’ Cortalex™ CBD Now Available Exclusively Online at Medical Cannabis by Shoppers Inc.

October 20, 2020

https://biotechstocktrader.com/cardiol-therapeutics-cortalex-cbd-now-available-exclusively-online-at-medical-cannabis-by-shoppers-inc/


....The Company recently received approval from the U.S. FDA for its Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease. CardiolRx™ is an ultra-pure, high concentration cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC-free (<10 ppm).

[DoctorRutch]

This is heading straight to $7.00 to $8.00 !!!!!!!! Have you guys seen who is involved in the phase 2 and three trials? Do your homework here. This one is a complete no brainer for me and my group. During the second wave, this could bring down the mortality rate. This has global implications and could catapult this company into the global medical spotlight. Buckle up peeps, buckle up!

[Tiresias]

I am not familiar with REFG. Cardiol is a Canadian company I believe and inter-listed. For full disclosure you can access public company documents through Canada's system for disclosure, like our EDGAR. It is called SEDAR and can be found at sedar.com. You can put the company name in and see the latest disclosure which was October 5 this year. The company filed a material change report related to the FDA testing approval. I would rely upon the SEDAR system for this company rather than OTC filings for this company. The one ad I saw that concerned me was a banner on top of the Ihub page with a big OK stamp-like add stating FDA APPROVED which some might think meant the drug was ok'ed for use when it fact it was approved only for testing, not use. A slight bit of enhancement but one which I dislike immensely because of its inference. Legitimate companies, especially those trading on the OTC hurt themselves when they lower themselves to that type of marketing - it always makes me feel someone is hyping the stock for insider enrichment. Testing can take years so that type of marketing provides an opportunity for pumping.

[I-Man]

This is an OTC stock firstly ! Then I am told Maria Bartiroma mentioned this company yesterday on Fox Business News?? I am very surprised at her doing so, knowing her for decades as I do, and this only an OTC stock. Not a big board stock...??

[I-Man]

So this is another "CBD" MJ type stock still again? Look at REFG to see what's NOT happening out there, as they have/had actual proprietary payment system with meetings with banking commission, etc and yet, their stock crappy for last few years...

[Tiresias]

Wrong board, apologies.

[Tiresias]

wrong board, apologies.

[DoctorRutch]

Give this multi bagger some time here. This is not your typical CBD company. These guys have an advantage having pure CBD. This will be far more attractive to the med community for its purity factor. Covid 19 swelling of the heart reducer right here.

[12yearplan]

This one addresses that somewhat
https://stockhouse.com/companies/bullboard?symbol=t.crdl&postid=31647982

Putting on the shelf of Shoppers Drug Mart RX100
Was supposed to be "immanent"

Buyer of dips.

[Tiresias]

Typical pharma activity regarding FDA approval for tests but a long road to hoe going forward. There are a number of CBD developers out there - I have used many of them but a challenge here because the feds still make it illegal to have products,good products, shipped in from Europe or Canada who make some very good products indeed. Here, so many shifty OTC companies that promise the moon but are just scams. Does anyone recall FITX or AEGY in the early days of this cannabis related sector? Have to be careful.

[12yearplan]

It's Friday, markets still confused - may be a good day!, GL
CRTPF$

[Tiresias]

Thank you.

[DoctorRutch]

It’s game on for the shopper drug mart deal in Canada. Looking for a tie in to an American pharma co here.

[12yearplan]

https://www.cardiolrx.com/cardiol-therapeutics-signs-supplier-agreement-with-medical-cannabis-by-shoppers-a-subsidiary-of-shoppers-drug-mart-inc/
link to the Shoppers Drug Mart deal

[DoctorRutch]

Point taken. I hear you. This is my personal sell zone at that level. The company needs to show good results from there trials that they are working on. The FDA press release and FDA’s blessing means a lot to me here. I really believe that cannabidol is going to have a positive impact on heart disease along with other illnesses especially tied to this Corona virus. Cheers!

[Tiresias]

And if your "promise" does not happen? On what basis can you promise $5 per share? This only is a test approval and that news did cause an uptick, in other words, normal speculative trading on a pharma. The interest in this stock at the time is minimal. It is a highly speculative play and there are no numbers to support the idea there is a big market for a heart related covid issues at this time that Cardiol could take advantage of. Could there be? Of course but at the moment to state definitely there is cannot be substantiated. Someone wanting to take a smaller stake and add to their position on continued development would be the more prudent decision but to go in large on a thinly traded stock with a preposterous target well ahead of any testing is only a stock promotion move. I am still waiting for a response to an earlier question for the link to the Shoppers Drug Mart deal (this is not directed at yourself).

I am not saying great things won't happen for Cardiol but every single company in this sector was supposed to reward investors handsomely and we have seen that not to be the case.

[DoctorRutch]

I promise you the stocks gonna run to 5 dollars real soon. I think this company has more news in the pipe. Plus I have read online that Steve Grasso of cnbc in the states who is highly respected, is into this as well.

[12yearplan]

Cardiol Therapeutics Receives FDA Approval for Investigational New Drug (IND) Application for Phase II/III COVID-19 Trial
1 hour ago

Trial will take place at major U.S. centers and examine the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease (CVD)

Oakville, Ontario--(Newsfile Corp. - September 25, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of CardiolRx™, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD). The trial will take place at major centers in the United States, where the prevalence of COVID-19 remains high.

Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity. Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, and which are frequently fatal, with an estimated 30 - 40% of patients who die from COVID-19 doing so from cardiovascular complications. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.

Cardiol's Phase II/III trial has been designed to assess the efficacy, safety, and tolerability of CardiolRx™ in preventing cardiovascular complications in hospitalized patients, with a confirmed diagnosis of COVID-19 within the previous 24 hours, and who have pre-existing CVD and/or significant risk factors for CVD. The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first twenty-eight days following randomization and first dose of study medication, a composite endpoint consisting of one or more of several common outcomes in this patient population, including all-cause mortality, requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.

The study was designed and will be overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease: Dr. Dennis McNamara (Chair), Professor of Medicine and Director of the Center for Heart Failure Research, University of Pittsburgh; Dr. Leslie Cooper (Co-Chair), Chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and Chair of the Department of Cardiovascular Medicine, Mayo Clinic; Dr. Arvind Bhimaraj, Medical Director, Advanced Heart Failure, Mechanical Circulatory Support and Heart Transplant Programs, Houston Methodist Hospital; Dr. Barry Trachtenberg, Director, Cardio-Oncology and Cardiac Amyloid Programs, Associate Director, Mechanical Circulatory Support Program, Houston Methodist Hospital; Dr. Wilson Tang, Director of the Center for Clinical Genomics, Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine, Cleveland Clinic; Dr. Peter Liu, Chief Scientific Officer and Vice President of Research, University of Ottawa Heart Institute; Dr. Carsten Tschöpe, Vice Director of the Dept. of Cardiology, Charité University Medicine Berlin, Germany; and Dr. Matthias Friedrich, Professor of Medicine and Chief, Cardiovascular Imaging, McGill University Health Centre.

Dr. Dennis McNamara, Chair of the Steering Committee for the trial commented: "As a Steering Committee, we are excited about the potential for this study to contribute valuable new information about the role of anti-inflammatory agents in the management of COVID-19. Now that approval from the FDA has been granted, we are anxious to get underway so that we can investigate the impact of CardiolRx in this very important disease process."

"Receiving approval from the FDA for our IND application to initiate a clinical program in COVID-19 patients represents a major milestone for Cardiol Therapeutics and provides the opportunity to significantly accelerate the commercial development of CardiolRx," said David Elsley, President and CEO of Cardiol Therapeutics. "The COVID-19 pandemic is providing our Company with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx in patients who have a prior history of, or risk factors for, cardiovascular disease and are most vulnerable to the virus. Subject to study outcomes, our discussions with the FDA indicated that the design and scope of our Phase II/III trial may be used as a registration study in support of a New Drug Application."

The rationale for using cannabidiol to treat patients with COVID-19 is based on extensive pre-clinical investigations by Cardiol and others in models of cardiovascular inflammation which have demonstrated that CBD has impressive anti-inflammatory and anti-fibrotic activity, as well as anti-ischemic, and anti-arrhythmic action, and that it improves myocardial function in models of heart failure. In pre-clinical models of cardiac injury, cannabidiol was shown to be cardio-protective by reducing cardiac hypertrophy, fibrosis, and the production of certain re-modelling markers, such as cardiac B-type Natriuretic Peptide (BNP), which is typically elevated in patients with heart failure. These data were accepted for presentation at the American College of Cardiology's 69th Annual Scientific Session held virtually on March 28 - 30, 2020.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease. The Company recently received approval from the U.S. FDA for its Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD). CardiolRx™ is an ultra-pure, high concentration cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC free (<5 ppm).

Cardiol is also planning a Phase II international trial of CardiolRx™ in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age, and developing proprietary cannabidiol formulations for the treatment of chronic heart failure. Chronic heart failure is the leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.

For further information, please contact:

David Elsley, President & CEO [phone]
[e-mail]

Trevor Burns, Investor Relations [phone]
[e-mail]

[12yearplan]

I'm soexcited! - it can go either way, lol. Check back 8am.
CRTPF$

[DoctorRutch]

This stock is halted. Can you imagine if they release something about how the got FDA approval like what happened to gw Pharma for epilepsy?? Here’s hopin. Bet this would then pop north of $7.50. To da mooooooonnnnnnn guys. Crtpf

[Tiresias]

Can you post the link showing they entered the building?

[DoctorRutch]

Shoppers Drug Mart has not left the building! You shall see :)

[Tiresias]

Who made that claim?

[Tiresias]

I see no reference to a Shoppers Drug Mart deal since it is so far ahead of testing and acceptance that statement appears to be pure hype.

[DoctorRutch]

CRTPF - The stock is continuing to rise here. Can’t wait for the shoppers drugmart deal to go through - huge revenues for their CBD product that is 99% pure - NO THC BABY!! This is a screaming buy here because the corona virus is going to keep killing people unfortunately and finally we have a company here that can lower the numbers. I’m calling 20 BUCKS a share on this one. Mark this post!

[DoctorRutch]

I’m holding this until we hit $10.00 dollars U.S. these guys have a coronavirus fighter. When the word gets out, this things going to fly like an eagle on acid. Crazy low volume. Potential buy-out by a BIG PHARMA CO.

[Alexulf]

The COMPLETE Cardiol Therapeutics (CBD) Video Presentation;

https://talk-deck.com/playback/6li85

Great input guys

WOO HOO!

[12yearplan]

Check!.

Wooohooo

CRTPF$

.. pleased to meet you..

[DoctorRutch]

If we get Grasso pounding the drum here, he alone can get the stock up to $7-8 + bucks per share!!!! Oh yeah baby, when Covid sweeps the world on its second wave, and I actually hope it doesn’t happen, but if it does, the stocks going to gain a lot more exposure. I’m sure the FDA and the health organization and Canada is keeping a very close eye on this, not to mention some of the other health agencies around the world. Anything to prevent death. Will be at four bucks here real soon. Anybody picking up what I’m putting down y’all?? Wooohooo

[Alexulf]

Todays value 24.70 dollars by Simply Wall.

https://simplywall.st/stocks/ca/pharmaceuticals-biotech/tsx-crdl/cardiol-therapeutics-shares

[12yearplan]

"Shooting for US listing Q4"
CRTPF$

[Alexulf]

Interesting Video; https://talk-deck.com/playback/6li85

[Alexulf]

The stock that gained 4.91% in yesterday's trading session. The company has commenced its Health Canada-approved first phase CardiolRx (TM) clinical study. CardiolRx offers extra strength formulation for pharmaceutical cannabidiol and has been formulated to offer high standard purity, stability, and consistency in the industry.

The phase 1 clinical study will assess tolerability, safety, and pharmacokinetics of single doses followed with multiple days CardiolRx ascending doses which will be administered orally to 55 healthy volunteers in fed and fasting states. The company will complete the study in Q4 2020 and it believes that it will represent the first approved high concentration cannabidiol formulation study containing less than 5 ppm THC.

[12yearplan]

$3.44 USD.*
Not much has changed Enterprise Value wise besides the natural maturation of the start up - don't see why it won't revisit previous price points on that chart. When or what for the rest of the year, hmm, no clue.. ?. Eisley said SDM stocking CardiolRx 100 was imminent. $10M worth of product bottled and sitting on SDM loading docks waiting for them to open the door should help - market likes revenue.
 
I wouldn't argue the merits of the business plan - not Eisley's first rodeo and I think people forget this isn't recreational CBD. I've been lucky in a half dozen trades with Cardiol because I'm patient and don't suffer from FOMO. Sure, a comet may hit head office but for the most part Cardiol isn't going away, lol.
Your question made me think what are the analysts saying* and for only $29.95 a month you can find out ;):
https://www.tipranks.com/stocks/tse%3Acrdl/forecast
IPub is for traders not investors. If you hopelessly must invest, lol - trade around a core position. Buy the sad, lonely/abandoned, boring periods and Sell the excitement. But, but, but, what if Cardiol shoots to the moon without me?. A 20% move on the moon is the same as down in the sewer.
Sorry for the long ramblin' reply, it's sorta like Cardiol and this board where I'm used to talking to myself - coming outta solitary confinement, lol.
Best of luck to you!.

But if you do fall in love with a stock, which is ok... u know - life is short/not to be missed:

You Pay Your Money and You Take Your Chance ;)

..In spite of themselves, graceful as these raindrops
Creeping spermlike across the car window
Stay or leave, give or withold
Hesitate or leap
Each step splashing sparks of red pain in every direction
And through it all, somehow
This willingness that asks no questions
You pay your money and you take your chance..

[Alexulf]

Thx 12yearplan appreciate our talk. Just a guess; 3.27 or more within this year? What do u think?

[12yearplan]

Great stuff Al, wonder where we go from here ;)
CRTPF$
https://ih.advfn.com/p.php?pid=staticchart&s=CRTPF&p=5&t=17&width=336&height=112&vol=1&delay=1

[Alexulf]

Latest news, 1 week ago;

[Alexulf]

FULL COMPANY OVERVIEW;

[Alexulf]

Hmm... it a lot to take in, 24 dollar? Only place I read this info, pretty significant fact for investors.

Step by step, I`m long on Cardiol.

[Alexulf]

Progress... let the force be with us!

Some updates and other mixed info; https://www.barchart.com/stocks/quotes/CRDL.TO/news

Did u see this one; https://simplywall.st/stocks/ca/pharmaceuticals-biotech/tsx-crdl/cardiol-therapeutics-shares ?

Interesting piece I cut from above link;


Is Cardiol Therapeutics undervalued compared to its fair value and its price relative to the market?


Undervalued compared to fair value
Share Price vs. Fair Value
88.1%
Undervalued
Current Price
CA$2.94
Fair Value
CA$24.72......!!! Any thougths on the calculation?

[StemCelzRock]

I bought in as Steve Grasso is on board and has not pumped this yet. But when he does, people are going to buy this all the way up to nine bucks. These guys are going to save many lives from Covid with their pure CBD known as Cardiol R X. people are now saying this could be the next GW Pharma. Get in now under three dollars because this stock is about the explode up.

[12yearplan]

Saweet Al: Health Canada approved Phase 1 clinical study of CardiolRx™
;)

[Alexulf]

Cardiol Initiates H C Approved Phase Clinical Study Of CBD CardiolRx(TM)

(The train is back on track 12yersplann

Oakville, Ontario--(Newsfile Corp. - August 26, 2020) - Cardiol Therapeutics Inc. ( TSX: CRDL ) ( OTCQX: CRTPF ) (" Cardiol " or the " Company "), a leader in the development of pharmaceutical cannabidiol formulations for the treatment of cardiovascular diseases, including heart failure and acute myocarditis, is pleased to announce the initiation of its Health Canada approved Phase 1 clinical study of CardiolRx™. CardiolRx is an extra strength formulation of pharmaceutical cannabidiol that has been formulated to set the highest industry standard for purity, consistency, and stability.

Cardiol's Phase 1 clinical trial is a double-blind, placebo-controlled, randomized study to assess safety, tolerability, and pharmacokinetics of single followed by multiple day ascending doses of CardiolRx administered orally in up to 55 healthy adult subjects, both in the fasting and fed states. The study is expected to be completed during Q4, 2020, and is believed to represent the first Health Canada approved study of a high concentration (100 mg/mL) cannabidiol formulation that contains virtually no THC (<5 ppm). This level of purity is extremely important for patient populations who should not take THC, particularly children, where THC can impact brain development, and older individuals who wish to avoid intoxication and who may be more susceptible to adverse drug effects.

By measuring standard safety parameters and the pharmacokinetics of CardiolRx, including the degree of drug absorption and resulting blood levels at escalating doses, the Phase 1 study will provide important information to optimize dosing levels for the Company's planned Phase 2 international trial in acute myocarditis. Cardiol's acute myocarditis trial has been designed by an independent steering committee comprising highly distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, and Charité Hospital Berlin.

Acute myocarditis is an inflammatory condition of the heart that represents a leading cause of sudden cardiac death in children and otherwise healthy young adults. The most common cause of acute myocarditis is a viral infection of the heart tissue which is initially responsible for the inflammation. Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the Company believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. The U.S. orphan drug program was created to offer companies significant incentives, including multi-year marketing exclusivity, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. The program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy syndromes as orphan diseases. Cardiol believes there is a similar opportunity to fast track the development of its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis, for which there is currently no accepted standard of care.

"There is now increasing evidence that the SARS-CoV-2 virus (responsible for COVID-19) is causing a disturbing number of new cases of myocarditis in young adults, perhaps most notably Red Sox pitcher Eduardo Rodriguez and several U.S. college football players. As global awareness of the devastating consequences of acute myocarditis increases in the wake of the COVID-19 pandemic, we see an opportunity to accelerate the development of CardiolRx as an important new cardioprotective therapy," said David Elsley President and CEO of Cardiol Therapeutics Inc. "The initiation of our Phase 1 clinical study represents another significant milestone for Cardiol, as we aim to position the Company at the forefront of heart failure research."

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX:CRDL.TO) (OTCQX:CRTPF) is a leader in the development of pharmaceutical cannabidiol formulations for the treatment of cardiovascular diseases, including heart failure and acute myocarditis. The Company's lead product, CardiolRx™, is pharmaceutically produced, manufactured under cGMP, and is THC free (<5 ppm). The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada.

Cardiol is planning a Phase 2 international trial of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary cannabidiol formulations for the treatment of inflammation in the heart that is associated with the development and progression of heart failure. Heart failure is the leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com .

[12yearplan]

https://pbs.twimg.com/media/EgNYVZZX0AAw_7Y?format=png&name=large

[12yearplan]

Cool Alex, hope we get some long awaited updates, thanks!
CRTPF$

[Alexulf]

Cardiol Therapeutics to present at MoneyShow Virtual Expo
August 20, 2020 | 9:30am EDT

Join us for Cardiol Therapeutics' Presentation
Dedicated to Conquering Heart Failure
featuring David Elsley, President & CEO.