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While we've heard this hypothesis of all the

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antihama   Friday, 07/03/20 04:37:41 PM
Re: MI Dendream post# 293337
Post # of 311179 
While we've heard this hypothesis of all the screened patients in the trial after the hold being placed in experimental arm from the get go before, I like how you make it dovetail w LG amd DI insisting they were all randomized
Quote:
What makes the most sense to me is that only 31-32 entered the trial after the halt and all of these patients were ‘randomized’ to treatment without the company’s knowledge. Since this maneuver actually weakens the study’s power, rather substantially, I contend that a regulator would only do so with the knowledge that the primary endpoint was a slam dunk. The DSM and regulators can be unblinded to the data while the company, investigators, patients and CROs are not, thus maintainIng the blind

This is supported by PFS being SS in alphapuppy's video in post 289738 (assuming the p-value needs to be under .05 and not .02 or.03 in some early speculations about splitting the p value w OS). We'll see soon if this becomes a theory or not.

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