Cadrenal Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease (ESRD) and atrial fibrillation (AFib). 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.