[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by jag009  – NJ, 2018-03-29 21:55 (2191 d 13:54 ago) – Posting: # 18619
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Hi,

❝ Actually, I am questioning the validity of FDA's Swr scaled 10% window on BE for NTID.


❝ If a GMR of 1.1 is clinically relevant (i.e. a test should be sensitive for this), and the NTID with a Swr of .22 will pass by ABE, this is a failure IMO.


Before we go further, does your hypothetical example pass the other two criteria stated in the NTI guidance?

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