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đź’ą 50% on Last Alert! NEW One Inside could be BIGGER?

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Our last alert went from $1.36 to OVER $2 in 2 days! Our Next one could be even MORE INSANE! -*ADVER

Our last alert went from $1.36 to OVER $2 in 2 days! Our Next one could be even MORE INSANE! [View online]( [UNSUBSCRIBE]( -*ADVERTORIAL*- Greetings All, There’s almost nothing more exciting than a biotech company that announces big FDA news. What if there was a biotech company that had big FDA news and JUST had its initial public offering in the same month? Oh… AND also hit a low point too recently? This is the story of Cardinal Therapeutics, Inc. (NASDAQ: CVKD), which only made its trading debut on the NASDAQ less than two weeks ago! The stock climbed as high as $6.75 this month after the company said the U.S. Food and Drug Administration granted a fast-track designation to tecarfarin, its anti-blood-clotting drug. Currently shares are at a low of around $2.80 and could be at a supreme value. It may only be a matter of time that Wall Street discovers this biotech company and their game-changing drug. Tecarfarin, a drug under development by the Ponte Vedra, Fla., pharmaceutical company, is indicated for the prevention of systemic cardiac thromboembolism in patients with end-stage renal disease and atrial fibrillation. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. "The Fast Track designation for tecarfarin is an important milestone in the development of this therapy and highlights the importance of finding an effective treatment for the prevention of blood clots of cardiac origin in patients with ESRD and AFib," said Quang Pham, Chief Executive Officer of CVKD. "We look forward to working closely with the FDA to evaluate this therapy as a potential new treatment option for this underserved patient population." There’s a critical market for CVKD’s drug. "Patients with ESRD and AFib have not been well represented in clinical trials evaluating stroke prevention," commented Dr. Sean Pokorney, an electrophysiologist, Assistant Professor of Medicine at Duke University, and Primary Investigator for the ACTOR-AF Tecarfarin versus placebo Phase 3 Trial. "The development of tecarfarin is an exciting opportunity to collect randomized clinical trial data on stroke prevention in patients with ESRD and AFib, and tecarfarin provides a unique opportunity to optimize stroke prevention in patients with ESRD and AFib,” said Dr. Pokorney. With tecarfarin, CVKD looks like an incredible biotech breakthrough company that could revolutionize treatment for a very important target group. It’s no secret that companies behind game-changing drugs can mint massive returns. Often pivotal drugs can be bought out by larger companies for billions. Case in point with Pharmacyclics which developed Imbruvica and was later bought by AbbVie for $21B! Now may be the best time to have CVKD high on your radar as biotech is anticipated to make a big rebound this year and the company JUST made its NASDAQ debut. Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) is focused on developing tecarfarin, a novel cardiorenal therapy with orphan drug and Fast Track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage renal disease, or ESRD, and atrial fibrillation (irregular heartbeat), or AFib. Tecarfarin is a Vitamin K antagonist oral anticoagulant designed to target a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis and AFib. It has already been evaluated in eleven human clinical trials and more than 1,000 individuals! In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. CVKD is currently focused on advancing their pivotal Phase 3 trial and any developments on this could be major! THE PROBLEM There are no effective treatment options for patients with ESRD + AFib  Commonly prescribed treatments for patients with ESRD + AFib may cause substantial harm, leading to outcomes such as stroke, systemic embolism, major bleeding, or death. Yet most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients. THE CVKD SOLUTION Tecarfarin is Phase 3-ready with a proven safety profile. The company is focused on advancing the development of tecarfarin, a novel Phase 3-ready, oral anticoagulant designed using a retrometabolic drug design process which targets a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis and AFib. This potentially gives tecarfarin a better safety profile and potentially eliminates specific side effects while maintaining or improving efficacy. PREVALENCE AFib is the most common arrhythmia, with its incidence and prevalence increasing over the last 20 years. There are more than 809,000 Americans with ESRD, with approximately 70% on dialysis. Approximately 150,000 ESRD patients also have AFib. AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients! CLINICAL TRIALS In a Phase 2/3 randomized and blinded trial, 607 patients with indications for chronic anticoagulation were treated with either tecarfarin or warfarin. The Time in Therapeutic Range, or TTR, with tecarfarin was similar to that with well-managed warfarin and tecarfarin appeared to have a favorable safety profile and be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no thrombotic events. When thrombotic and major bleeding events during the blinded period were combined, a numerical imbalance favoring tecarfarin over warfarin was seen (warfarin 11 subjects, 3.6 %; tecarfarin 5 subjects, 1.6 %). In a subsequent Phase 1 study with 23 patients with chronic kidney disease, the metabolism of warfarin was inhibited, but not tecarfarin. The safety of repeated dosing of tecarfarin in CKD patients remained unknown. However, if the pharmacokinetic findings of this single-dose study are present with repeated dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy. PIVOTAL PHASE 3 STUDY CVKD is currently focused on advancing their pivotal Phase 3 trial, called the ACTOR AF Study, with an intent to initiate in the second half of 2023. It is expected to be a randomized, double-blind, placebo-controlled outcomes study of tecarfarin vs. placebo in 492 patients with both end-stage renal disease and atrial fibrillation who are not currently being treated with a chronic oral anticoagulant. PARTNERSHIP The company has licensed out the rights to tecarfarin for several Asian markets including China, to Lee’s Pharmaceutical Holdings Limited, an integrated research-driven and market-oriented biopharmaceutical publicly listed company based in Hong Kong with over 25 years’ experience in the pharmaceutical industry in China. Lee’s Pharmaceutical Holdings Limited is developing tecarfarin as an anti-thrombotic for patients with mechanical heart valves. In 2020 and 2021, Lee’s Pharmaceutical Holdings Limited completed two Phase 1 studies in China and Hong Kong and is currently preparing for its Phase 2 trial, which is expected to begin patient enrollment in December 2022. In Summary… Big pharma companies pivot towards innovation and CVKD has definitely entered the biotech space on Wall Street with one of the most innovative drugs around right now. With shares sliding after the company’s IPO, now could be the best time to have the stock on your radar. Wall Street may need more time to digest the big FDA news announced about CVKD’s drug receiving fast-track designation. A drug that receives Fast Track designation is eligible for some or all of the following: - More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval. - More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers. - Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. - Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA. Could FDA approval be in CVKD’s future? This is one biotech company to keep a close eye on! Start your research now! Copyright 2023 © TopStockTips.com is owned and operated by the owner of CareBear Marketing Group LLC and IR Agency LLC (www.IR.Agency). Disclaimer and Privacy For more Information please contact Support@TopStockTips.com CareBear Marketing LLC and IR Agency LLC and their affiliates and control persons (the “Publisher”) are in the business of publishing favorable information and/or advertisements (the “Information”) about the securities of publicly traded companies (each an “Issuer” or collectively the “Issuers”) in exchange for compensation (the “Campaigns”). Persons receiving the Information are referred to as the “Recipients.” The person or entity paying the Publisher for the Campaign is referred to herein as the “Paying Party”. The Paying Party may be an Issuer, an affiliated or non-affiliate shareholder of an Issuer or another person hired by the Issuer or an affiliate or non-affiliate shareholder of the Issuer. The nature and amount of compensation paid to the Publisher for the Campaign and creating and/or publishing the Information about each Issuer is set forth below under the heading captioned, “Compensation”. This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. Nothing on this website should be considered personalized financial advice. Any investments recommended here in should be made only after consulting with your personal investment advisor and only after performing your own research and due diligence, including reviewing the prospectus or financial statements of the issuer of any security. CareBear Marketing Group and/or IR Agency LLC, its managers, its employees, affiliates, and assigns (collectively the "Publisher") do not make any guarantee or warranty about the advice provided on this website or what is otherwise advertised above. To the maximum extent permitted by law, the Company disclaims all liability in the event any information, commentary, analysis, opinions, advice and/or recommendations provided herein prove to be inaccurate, incomplete, or unreliable, or result in any investment or other losses. You received this message as part of your subscription to TST. TST is a free financial news and information website. 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Flesch reading score measures how complex a text is. The lower the score, the more difficult the text is to read. The Flesch readability score uses the average length of your sentences (measured by the number of words) and the average number of syllables per word in an equation to calculate the reading ease. Text with a very high Flesch reading ease score (about 100) is straightforward and easy to read, with short sentences and no words of more than two syllables. Usually, a reading ease score of 60-70 is considered acceptable/normal for web copy.

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