Jeg er som flere andre her skuffet over at vi nå i mars kun får vite om PFS er nådd eller ikke, og har hele tiden trodd at de la noe mer i det når de snakket om topline results.
Men ser nå at de på Q1-22 fikk et direkte spm om dette, og kanskje at vi utfra svaret der må innse at de har sagt det samme før (kan høres fra vel 52 min ut i presentasjonen) :
Spm : What kind of data will be communicated at the time of readout of topline data?
Carlos : So it’s important really, and thank you for the question. Because we are going to have a lot of results – and all these data will be analyzed after the events, let’s pick up that INITIUM are reached. It’s important, as you already know, that we preserve several part of the data to be published or presented at medical conferences because those are very important for the company. So what we will disclose is normally what we call topline results that I referred to the primary endpoint, in this case, PFS. So, is there a difference between the groups and is differences positive? So basically it’s a study positive, that’s what we will communicate. And that is the key part. But then, a lot of the details, as we already communicated in the past, and I think our shareholders understand that they are extremely valuable to present at a conference and to publish.
Jens : And just to add to that, on the safety side, also on the background of the safety in the 2 arms. That will be very important for us to understand both the efficacy and safety side. But as Carlos said, these results are very valuable for us in the further discussion with the authorities, with the doctors that hopefully will be part of a Phase III trial moving forward. So, it’s a lot of results and only the PFS will be presented from the efficacy side upon end of study.
