Biotech Values

[DewDiligence]

ITMN – If Feuerstein was referring to the repeated measures analysis of ranked change from baseline, he should have said so inasmuch as ITMN made no claim that this was a secondary endpoint. The way Feuerstein’s piece was worded, he left the impression that some of the three secondary endpoints in each trial—six-minute walk, categorical FVC, and PFS—were post hoc, when it fact all of these analyses were prespecified.

The reason these secondary analyses were deemed exploratory is spelled out in the PR (#msg-35288566):

Although pooled analyses of secondary endpoints were pre-specified in the study protocol, these analyses are nonetheless considered exploratory because the primary endpoint of both studies was not met.

As noted in my previous post, this is standard tenet of clinical-trial statistics.