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ilovetech

01/18/23 8:44 PM

#560478 RE: Reefrad #560453

Hint: Medical Device Companies are held to a lower standard for approvals. True. Why? Don't know.

ILT
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HyGro

01/19/23 2:16 AM

#560528 RE: Reefrad #560453

Don't use "placebo" trials for cancer trials -- unethical. They used an internal comparator, the preferred method, while NWBO couldn't because they confounded their trial with the multiple dosing and had to toss their comparator arm out and find an external comparator methodology post hoc. Certainly not going to go over well with the regulators -- especially when they see all the bias in the external comparator trial selection.