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Jhawker

04/28/21 11:21 AM

#357291 RE: KMBJN #357289

No offense but could you provide a link. “ I'm remembering something ”
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sunspotter

04/28/21 11:26 AM

#357293 RE: KMBJN #357289

"Sure would be nice to be able to see trial protocols."

I agree, in particular what dose of brilacidin is being used in the three and five day regimens, and how "standard of care" is defined.
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loanranger

04/28/21 12:35 PM

#357313 RE: KMBJN #357289

I think that the idea that the "planned interim analysis" included an efficacy analysis gains a lot of support from the fact that it was announced in an October PR that announced the pre-IND meeting request.

That would have been well before any talk between IPIX and the FDA regarding any dosage considerations so there would have been no need to plan a specific safety analysis at that time for that purpose.

The planned analysis may not happen given the size and status of the trial. Or it could happen without public notice. I would have expected the DMC to take note of the plan when hired.