biosect, you want to argue that compassionate use of a drug would not be allowed if a trial was futile.
Suppose, for example, that the DCVax-L trial is trending well in OS, but PFS is not doing well so was futile.
Or suppose the mess. subgroup was doing well, but there simply were not enough to prevent futility (kind of like Opdivo in front line NSCLC where it clearly worked with high PD-1 expressers, but failed because they were the minority).
Would you argue in either of these cases that compassionate use should be halted?
If so, how would you explain this to your fellow posters who are suggesting either of these could be sufficient for approval?
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