Fast Track for Hep C Drug PSI-938
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The Editors at Hepatitis Central
August 29, 2011
Showing potential to be a monotherapy for chronic Hepatitis C infection, the FDA has awarded Pharmasset with fast track status for its drug in development, PSI-938.
Pharmasset hepatitis drug may get faster review
The Associated Press August 24, 2011
PRINCETON, N.J.
Pharmasset Inc. said Wednesday 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.
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http://www.businessweek.com/ap/financialnews/D9PAHRT01.htm
