Published in Medical Letter on the CDC and FDA, March 13th, 2005
The investigational new drug application filing, made on November 21, 2004, underwent the customary initial review by the FDA. The FDA has requested additional information beyond what is currently available to be included for review. CyGenics expects it will require 6-8 months to furnish this information. In addition, a review of the trial design for the phase...
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