Published in Drug Law Weekly, May 3rd, 2005
The company also stated that it continues to expect to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2005 to initiate clinical studies in the U.S. Safety and PK study results are expected to be available in a timeframe that enables Hollis-Eden to initiate a pivotal efficacy study in non-human primates in the second half of 2005.
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