PRINCETON, N.J. (AP) – Pharmasset Inc. said that the Food and Drug Administration has awarded fast track status to its hepatitis C drug candidate PSI-938.
The FDA’s decision will allow Pharmasset to submit its marketing application step by step instead of all at once. Regulators will also have the option to review the application in six months instead of the usual 10 months.
Pharmasset is studying PSI-938 as a single treatment for hepatitis C. During the third quarter it plans to start a clinical trial that will test a combination of PSI-938 and its most advanced drug candidate, PSI-977.
Date: August 24, 2011
Source: Associated Press
Filed Under: Drug Discovery