"Later on, they review the MRI and determine that that pt had a psPD event and shouldn’t have crossed over. They can’t un-crossover that pt so what do they do? Eliminate that pt from the calculations? I’m just not seeing it. However, I don’t have these type concerns to begin with since multiple scans are used before a pt is determined to have progression."
You weren't talking to me, but I had speculated about this earlier. I agree that it would be a mess if they changed their minds about previous progression determination. There is a strong need for that determination to be set in stone before crossover. So my speculation about employing a new and improved method for determining progression including distinguishing pseudo, in the post analysis, is dubious, as many have pointed out including AVII and Reefrad, and to some degree yourself here.
However, while there is a strong need to nail down progression before crossover, there is even a stronger need for an effective treatment for GBM. I would argue that however messy, if post analysis of progression using a new and much improved method, based on existing MRI scans, reveals remarkable efficacy, then I don't think they could ignore that. Shrugging formalities is dangerous in part because the statistics underlying those formalities is not transparent to most. But if people that do understand the basis for those formalities can see that they are in this case blocking the approval of an effective therapy... then they should have the power to push a drug through to the point of being profitable for a company to produce so as to move to confirmation. And that is what various early approval modalities are all about. Including one that has been talked about here recently and may well be currently under review. I will not say much more until Sis gets in.
The FDA is absolutely obligated to prevent another disastrous Thalidomide indication from happening, as are all regulatory agencies around the world. But this is certainly not another thalidomide, so non-linear thought is likely allowed here, even if NWBO did not say, "Mother May I" before curing brain cancer.
