Item 4 should not be moved forward because it is an incorrect use of SCAT.
Lab team is concerned about bringing this to FDA without more discussion around downstream impacts on the model and CT.
Lab team thinks it might be best to work with Eanna and Alan to determine the 1-3 approaches that are best and then get FDA feedback.
Lab team also asks Eanna to consider whether an FDA meeting is still appropriate now but to ask more high level questions about what type of unit data they'd like to see in SDTM submissions. There was a paper written in 2013 by FDA about SI units but there has been no movement since. Has FDA's thinking changed on this?
We will reconvene on to begin discussing the list in more detail.