Trius Therapeutics, the San Diego-based developer of antibiotics, said today it has agreed with the FDA on a special protocol assessment that establishes the design for a pivotal clinical trial. The clarity from the FDA is vital to Trius and its lead drug candidate, torezolid phosphate. The company postponed its IPO plans in March after it learned of new FDA guidelines that altered its plans for a pivotal antibiotic study. Trius didn’t say in today’s statement what its next move is on the IPO front.
Author: Luke Timmerman
Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.
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