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Wednesday, June 03, 2020 6:14:53 PM
'Wreaks havoc'.
Yep that was it. How could I forget?!
We really don't know what is the status of PFS in the final SAP.
I'm inclined to think that the 'emphasis' is more on OS now, but we really don't know about how the alpha split might have changed.
It seems sensible to assume they ran the trial as long as they have done, because they believe they need the very mature OS data.
And we don't know what the regulator(s) attitude is about accepting an adjudicated PFS outcome anyway.
As I've said previously, the little hints, if there are any, suggest OS is the main focus.
But I might be wrong.
A lot depends on what the DMC did report to the company after the putative efficacy IA.
There is still the possibility that the DMC unblinded look found that the data was overwhelmingly good at that point, and that is why a regulator might have advised that all further recruitment was to go to treatment (or so it seems).
That's the glass full interpretation, and it has never been disproved.
But personally, I don't think that is what happened.
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