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Re: sunspotter post# 357303

Wednesday, 04/28/2021 4:24:51 PM

Wednesday, April 28, 2021 4:24:51 PM

Post# of 405172
You are confirming another reason (beside double-blinded) why there was not and could not be an "Interim Efficacy Analysis" in the Brilacidin-COvid-19 Clinical Trials. Just based on the CT design requested, and planned and inserted into the Protocol of the Clinical Trial APPROVED by the FDA...

The downside of interim analyses is that they raise the hurdles for statistical significance of the final results.



It not a matter of "Downside" (which is a strawman setup)...its a matter of design...Efficacy Interim Analysis was NEVER PR'd...and would not have been simply because it was never in the protocal and could never be done based on the 3 to 5 day safety dosing and, then continuing the remaidner of the patient with a 5 day dosing protocal...

Bottom Line...there was no representation or PR that interim efficacy would ever be done...

its a Strawman setup... All referenced Efficacy is FINAL ANALYSIS... none state "Interim"
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