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Re: Doktornolittle post# 54521

Saturday, 02/20/2016 1:27:22 PM

Saturday, February 20, 2016 1:27:22 PM

Post# of 732922

How many times has early regular approval been brought up?



That's probably my fault.

I was the first to note that the odds of FULL approval based on an interim look here (Stat sig PFS and OS) are much higher than the odds of an Accelerated Approval based on an interim look here (stat sig PFS).

I was just trying to be balanced for Senti.

The chances are so incredibly remote.

But here is a fun fact for you: The DSMB in this trial routinely views comparative efficacy data. Yes, "comparative; separated by treatment group. They do this at least twice a year. They just can't act on it to stop the trial for efficacy until the time of a formal efficacy analysis.(Though they could stop for harm at any point). And the reason they couldnt stop for efficacy (assuming there was some observed) is..... Multiplicity; the trial would lose it's A&WC status. I hope you watch some of those multiplicity videos.

I better run and hang some blinds for Mrs. Avii77, if I put it off any longer there will be hell to pay later.
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