You're right, Dok. I was caught up on the fact that a trial is usually designed with a primary endpoint other than possible surrogate endpoints. It seems this entire trial was designed on a common surrogate endpoint (PFS), with the aim of receiving AA due to its cited correlation with OS, in particular where GBM is concerned. This was apparently the entire strategy at the onset (as per their mention it was "designed" to enable them to seek AA). Perhaps LP is surprised as much as any of us that it appears talks are moving forward regarding AA at this interim instead of the second. She was pretty confident it wouldn't happen so soon (90% continue probability claim). Another insider is likely firewalled and in discussions with the FDA and DMC, and she probably then has no intimate knowledge of what's currently contained in FDA minutes. How is it none of us saw this before? Nice find, longusa...
Regarding the trial continuing in Germany, LP did make that clear to us. So they will be enrolling patients in the trial in Germany, but of course, they will only add to the treatment arm (which remember, is 2:1 with the placebo arm). Also, companies can move around initial estimates on enrollment of different locations. And so, if it was expected before the PEI hosp ex approval that most of the rest of treatment patients needed should come from outside of Germany, they can now change that to be mostly from Germany. Anyway, bottom line: any enrollment lag can be immediately helped due to the situation in Germany.
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