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Monday, May 17, 2021 9:13:28 PM
It also assumes that the Aug 2015 halt was due to a safety event (i.e., death) which was investigated as it always is by the DSM who knew that the study was randomized 2:1 which amplified their finding very quickly relative to how long one must wait to ensure that early will statistically beat late. Because it is the DSM, then no efficacy analysis need be performed during interim or refresh or whatever you want to call a blind look at the data.
It then assumes that Linda’s Utah presentation is roughly the same presentation that she made to FDA.
It also explains why IDH mutations needed to be evaluated because once you prove placebo is in fact barbaric then you cannot go backwards. However, with the right planning, you can build what you need to do all the new validation of a new database with an existing database. One who has worked with another can assume that this plan would be part of the negotiations.
And Linda has a lot of set up to do like the statistical model, like PFS vs adjudicated PFS, but only 15 minutes to do it in with questions at Late Breaker at ASCO.
So Utah and Mt. Sinai, can you help a lady out please? Why certainly friend
Now what are we worth but it ain’t $10 and together can we turn this whole thing upside down? I don’t want this feeling to go away. Sometimes SCHADENFREUDE is okay and sometimes GESTALT includes the idea that the kingdom is within you and you should follow the sun because she is magnificent. And sometimes geeks who love Super Mario just want a place to call home, and some people love Biotech but are sick of the hours demanded.
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