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.
Just and FYI on Adam and my perception of his bias. If you notice he only had a partial quote of Colbert (who IMO isn't as good an analyst as I first thought). He actually had a bigger quote of his then cut the more positive part out. In the Reuters piece one can see it. He also had a more balanced quote from Adam Cutler (one of the better analysts following ITMN) and then cut that too in the PM release of the story.
As far as his reference to "exploratory" Dew addressed it but IMO He clearly implied it was retrospective look. I think he is either lazy/sloppy (didn't fully read the press release or listen to the call), or trying to mislead readers. I will however concede its not the biggest misrepresentation of facts.
(Disclosure I may be perceived as a known Adam Basher :-) though I actual do enjoy reading some of his columns though it seems lately not as often).