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Re: Nick119 post# 451210

Monday, 03/14/2022 7:04:06 PM

Monday, March 14, 2022 7:04:06 PM

Post# of 701953

I strongly believe that the hold up is related to assembling the historical "placebo" control arm data and this is what is specifically causing the time delay.


Then you do not understand what "datalock" means.

As of datalock all data used for the analysis is locked down ready for analysis. The analysis plan has been specified down to the tiny details like the version of SAP (or whatever) to use. There is nothing at all left other than to crunch.

And this included external control arms in trials that use them. Again, read the FDA paper on this.
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