FDA questioning the validity of null rate of 45% - went through a whole series of other options of data - mostly with similar rates, and all with limitations on data. So seeking guidance as to whether the null rate of 45% is appropriateor how else they can determine an appropriate comparison response rate for un-treated patients.
Essentially all other data set options have limitations so FDA wants guidance as to what is appropriate
Ryoncil: ODAC/FDA Meeting Discussion, page-1073
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