CE Mark Odds, page-141

Gekkowolf: believe it or not, a regulator is entitled to scrutinise the efficacy of a treatment and decide if a treatment actually works before it can approve! Doesn't matter what they may have told a company to do before. As I understand it, this is a Class 3 (high risk) device, not an app. Instead of relying on market announcements, why not spend some time taking a really detailed and objective look at the trial data (it's all available on the company website in the poster presented at ASCO), and maybe getting an expert's view- such as an oncologist. I did just that, and it's very helpful and will help you understand the positives but also the limitations- and therefore why a regulator may have concerns. Then, and because there's no control arm, go and research what results the same patient group would get with the same background chemotherapy that was used in the OSL trial (FOLFIRNOX or gemctabine + abraxane). In fact as most of the OSL trial patients got gemcitabine + abraxane according to the poster, go check out clinicaltrials.gov website where Celgene have posted their results for more than 100 patients with unresectable locally advanced pancreas cancer given gemcitabine + abraxane. Median survival almost 19 months....