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DonShimoda

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DonShimoda

Re: DonShimoda post# 250

Wednesday, 06/09/2010 6:34:06 PM

Wednesday, June 09, 2010 6:34:06 PM

Post# of 80490
I just reviewed the Tasigna approval time-line and it looks like their Phase 3 trial started in March 2006. The trial was stopped early and accelerated approval was granted in Oct 2007, basically 18 months from first enrollment. http://www.clinicaltrials.gov/ct2/show/NCT00302016?term=Nilotinib&rank=49

fyi, the primary endpoint was a 40% MCyR in chronic phase patients. http://www.cancer.gov/cancertopics/druginfo/fda-nilotinib
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