Of the Upcoming Game-Changing Actions
THE EXPECTED FDA APPROVAL OF JAZZ DRUG DEFIBROTIDE
On March 31, the FDA is expected to decide on the approval of Jazz Pharmaceuticals’ (JAZZ) drug defibrotide. The drug is for patients with hepatic veno-occlusive (VOD), also known as sinusoidal obstruction syndrome (SOS), with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT).
Optimism about the FDA decision is prevailing among analysts and observers as the results of the pivotal phase 3 trials as announced by Jazz demonstrate statistically significant improvement . . .