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Wisconsin Technology Network - Biotech

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May 15, 2008

FDA delays embryonic stem cell clinical trial

 Geron Corporation, the Menlo Park, California-based company had sought permission from the U.S. Food and Drug administration to begin a human trial to test its GRNOPC1 stem-cell compound in patients with spinal cord injuries. In a press release dated yesterday, Geron anounced that they received oral notice from the FDA had delayed the Investigational New Drug application the company filed in order to begin clinical trials.  This delay does not mean that the IND was rejected, but until Geron receives the official letter, it will not known why the application was delayed or how long it will take to rectify the issues the FDA has.

Geron worked with the FDA over the last four years leading up the filing of a 21,000-page IND application.  Read the full press release here.

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