Wednesday, January 30, 2013 9:13:40 PM
That would be the logical conclusion if you believe the statement that 3mg was not affected. It also means that without labeling screwup the results for 1mg Bavi would be at least little better. Looking at the K-M curves 'little better' for 1mg Bavi really means that 1mg works just as good as 3mg, or even better. Looks like the optimum dose, at least for 2nd line NSCLC, lies somewhere in between 1 and 3mg. Based on that logic FDA should approve p3 trial with two different doses.
Also if one were looking at KM curves without knowing which arms were affected with labeling errors normal conclusion would have been that 1mg and 3mg were affected as those two curves look almost identical. It is actually hard to believe that 1mg and placebo arms were mixed up looking at really great separation of placebo and 1mg on the K-M curves. This issue is even more confusing after the statement that 3mg was not affected.
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