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Re: boi568 post# 300922

Saturday, 02/27/2021 12:50:04 PM

Saturday, February 27, 2021 12:50:04 PM

Post# of 517634
boi568

In that context, the upcoming imaging study is critically important.



Possibly. If you are right then there would already be an agreement and protocol for validation which carefully defines the entire (step x step) process protocol, metrics/controls/criteria, end points and acceptance criteria controls. This plan would have been previously approved by FDA. Happens all the time.
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