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FDA puts Geron spinal cord injury drug on hold
May 16, 2008 | Staff | Forbes News
Biopharmaceutical company Geron Corp. said Wednesday the Food and Drug Administration has placed a clinical hold on its experimental cell therapy for spinal cord injury, GRNOPC1.
A clinical hold is an order that the FDA issues to delay a proposed trial or suspend an ongoing investigation.
"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," said Thomas Okarma, Gerons president and chief executive. "Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders."
The company said it is "disappointed" given that the submission has been in development for four years and has been predicated on discussions with regulators.
