|Clinical and Regulatory|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Indication:||secondary prevention of cardiovascular disease|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Aralez Pharmaceuticals|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.