flipper44,
The 66 events that triggered the first scheduled interim analysis, that ended up being for safety only, may have been eventing at only a slight PFS advantage based on modeling discussed on SA and elsewhere back in 2013/2014. The way trials are set up, though, modeling is difficult to get right because there is generally no strict linear enrollment of SOC to treatment patients. In this case a 2 to 1 ratio is not 2 treatment patients followed by 1 SOC patient as each new patient is enrolled. That said, the idea that all patients appear to be living longer with a referrence to 24 months MOS as the baseline and other statements that point to early treatment vs later treatment comparison, may indeed point to early (vanguard) patient benefit compared to later enrolled patients for PFS but much better than expected MOS for all patients and perhaps later treated patients having better PFS as well. The context of these statements seems to be with regard to treatment arm vs crossover arm but vanguard to non vanguard is also possible. If this is the case then later enrolled patients benefitted from TFF manufacturing without initially realizing this would happen. By the time Germany was ready to come on board this benefit may have begun to be recognized and they wanted to know why. Getting this resolved would take some time and since it affects both L and Direct, news and trials appear to have been deliberately held up while the issue is being resolved. NWBO and or Germany probably felt they were seeing some unexplained benefit which led to NWBO voluntarily suspending new screening and giving their data and understanding of its interpretation to regulators. In the mean time, the Germans seem to have wanted more details about the patent which may have led to HE being held up on their end as well as planned trial enrollment there which led to everyone being held up and this long delay while issues on both sides of the pond are being worked out. Perhaps a German company was interested in a combo trial as well so everything went quiet with all the discussions, reviews and investigations going on. One thing is for certain and that is there is a great deal of activity going on behind the scenes and resolution seems poised for later this year.
