The FDA approval process is fraught with risk and uncertainty, particularly when it comes to new chemical entities ("NCE") that risk failure on a number of fronts, including safety and efficacy. Occasionally, investors may encounter a drug that is significantly derisked due to its status as an approved product in other dosage forms or in other countries. Such is the case with Avenue Therapeutics (ATXI) and its IV tramadol product. Though the product is in Phase III studies and is technically an opioid, the product offers a lower side effect profile and superior