I wouldn't do (another) costly Phase 3 without a partnership. The other trials I talk about are much cheaper and over the next couple years. My preference is not to do Investigator ones since they take for ever to enroll but I would do that as a last resort (for a promising proof of concept).
On the 12/15 JP Morgan sponsored call they did not give a sense of changing their plans as far as rollouts. I think France, Spain and Italy are pretty far along in the negations. If we get to Q2 and no more big territories have pricing agreements then I would start worrying the IQWiG recommendations are having an impact on negotiations.
At this point I am not too concerned about the impact outside of Germany. And even in Germany I think the impact will be a mid to modest price reduction (but they announced a higher price then I expected to begin with). People can't just ignore the label and frankly its far superior then I would have expected (particularly morality mention and allowing things from the failed study).
The German negations process will be a long one. The next step is a formal response by the company (I think by January 5/6 or something like that). I would expect Dan Welch to update investors at the JP Morgan call later this month.
Hope that info helps.
