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Article: Immune Response Pins Hopes on Study Results.(Brief Article)
- Article from:
- San Diego Business Journal
- Article date:
- September 10, 2001
- Author:
CopyrightCOPYRIGHT 2001 CBJ, L.P. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Officials at Immune Response Corp. said they will rely primarily on data from a small human trial as it is getting ready to file for regulatory approval in Europe and the United States for its experimental vaccine drug Remune.
Two analysts, however, raised concerns whether Immune Response will be able to convince regulators of the merits of its drug based on the result of a Phase II trial. The FDA typically requires positive data from Phase III trials to approve a drug.
"I think it's going to be very difficult to get Remune approved," said Sushant Kumar, an analyst with Mehta Partners in New York City.
"This is a very tricky area," added John ...