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Sunday, April 17, 2022 1:04:34 PM
My contention is that regardless of what may have actually happened, regulators apparently endeavored to keep them blind for good reason.
This discussion is wrt MIB's assertion the FDA secretly crossed the patients already enrolled to treatment.
They could not do that w/o many knowing The crossover election is the patient's. That is the consent form they signed. And would also mean the MD and likely and at least one other party would know.
And they could not keep LL out of the loop as the PI. She is the one charged with insurring the trial is run ethically.
And even if you accept the FDA could game their own regs (which by law requires the sponsor be kept in the loop), what about other countries?
And it would have been obvious in the blended PFS data., Every remaining un-progressed patient censored the same time?
The theory the trial was crossed over in 2015 flies like a lead ballon.
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