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Tuesday, April 14, 2020 12:35:28 PM
For this trial, the "last patient must be 60 months" or anything like that is a bunch of crap this board made up.
Not necessarily 'a bunch of crap'.
If, in the submitted SAP draft, NWBO stated an intention to statistically focus heavily on OS and, in particular, use milestone survival, and RMST to elucidate the long tail, I find it perfectly plausible that a regulator might have commented back that waiting for even more mature OS data in the shape of full OS60 data might be advisable.
Which would be like presenting NWBO with a bit of a cleft stick situation, where in effect they have to follow the advice, or probably be damned later after the BLA submission.
FWIW, I think something along these lines is precisely why they haven't yet unblinded.
In other words the 'bunch of crap' is the most likely reason, imo.
As well as waiting for OS60, I also postulated 85% OS events. Though I actually gave it very little credence, because there is something unseemly and slightly unethical about it (to my mind), and probably to regulators.
I was just quickly coming up with possibilities as to why unblind / datalock might be out of NWBO's control, as was suggested here based on something that DI (or was it LG) was supposed to have said.
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