This is also interesting, I guess inline with @Snoeffelen contribution regarding discussions with FDA for FimaChem:
PW:
"
The study has a randomization, one arm of patients get only standard of care, gemcitabine plus cisplatin. The other arm gets the standard of care, but up to 2 treatments of fimaCHEM in addition.
The primary endpoint of the study is progression-free survival. And overall survival will be a key secondary endpoint. Of course, the regulators want to see that this translates over to survival, not just that you get progression free – or the patients are progression free. But there’s a very good link between progression-free survival and overall survival in this specific disease.
The interim analysis primary endpoint is also PFS then followed by objective response rate that you have seen data on previously here.
We will establish an independent data monitoring committee that have regular reviews, but there is no planned formal futility stop for this. So it’s not like planned stop for if this is futile. But there is – but there will become recommendations from the IDMC and those recommendations will be made public when they are made.
So with regard to that, what is the progress reporting that we’re going to do with this pivotal study? We will communicate key milestones in press releases such as start of the study which is first patient dosed, and whatever IDMC recommendations we get during their review. We will be blinded to the data ourselves, but the IDMC will be open to the data and can give us recommendations on a general basis on what to do. Any clinical trial results presentations, filing, et cetera, those key milestones that you have through a development. And progress will be updated in quarterly reports where we will report number of country approvals and number of sites open for enrollment. And also, of course, whether the study is going according to plan or not"
