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Re: exwannabe post# 596765

Monday, 05/29/2023 12:40:26 PM

Monday, May 29, 2023 12:40:26 PM

Post# of 634342

particular concern for bias would be the selection of an external control arm from a completed trial whose outcomes are already known.

Sponsors should finalize a study protocol before initiating the externally controlled trial,

Everything you quote is the FDA trying to warn Sponsors to NOT select an externally controlled trial to compare its trial data with to prevent biased and cherry-picking. Jeez grammar school FDA regulations here ex. Do you really think that Dr Liau does not know that?

again NWBO did not compare the trial data against a completed trial whose outcomes are already known., you are making this up. NWBO compared its data against SOC.