FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints.
Shawn Cain, CEO and president of Arbios, said: “We currently do not have the financial resources to fund the pivotal trial and our ability to finance the company is contingent upon, among other issues, agreement on a primary endpoint with a reasonable number of patients required for the trial.”