Replies to post #330680 on Bioelectronics Corp (BIEL)

[GetSeriousOK]

The numbers won't change after Ilfeld makes those edits. We're just looking at the numbers.

The Phantom Pain study (which has already been published) has similar Quality Control warnings:

https://clinicaltrials.gov/study/NCT05392803?tab=history&a=6#version-content-panel

Regarding gender: there were no hypotheses about gender in the protocol so gender is not a factor. Ilfeld could cherry-pick the results by gender and/or by indication but the CMS would not accept cherry-picked results.

Bottom line: BIEL can't show this to the CMS. BIEL will have to show the CMS their other data and hope the CMS is generous, which they might well be, considering the political pressure to reduce opioid use.