Published in Pharma Law Weekly, March 21st, 2006
The submission completes this "rolling" NDA that was initiated in August 2005, under the continuous marketing application (CMA) pilot 1 program. The FDA agreed in June 2005 to file and review the NDA.
Dr. Francesco Bellini, chairman, president and chief executive officer said, "We believe that the NDA package supports the clinically and statistically meaningful effect of this product candidate on the...
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