Bioelectronics Corp (BIEL)

[GetSeriousOK]

This gender gap in efficacy did not show up in the Knee or Foot Trial.

Where do you find the knee and/or foot data split out by gender? How do you know the efficacy "did not show up?"

Seems more likely that those researchers simply didn't identify gender.

I am suspicious of the Koneru brothers. I don't think they know how to run a good clinical trial. I think they would have combined male and female data if they could, but the combination resulted in less than statistical significant efficacy, so they tried to cherry-pick and split the data by gender, hoping to get THAT by the FDA using smoke and mirrors.

The Back Trial shows Substantial Equivalency for women

does it? the PR doesn't say that. The PR says the opposite: there is no substantial equivalency because the foot and knee data didn't split the data by gender.

Based on the sketchy wording in BIEL's press release, I also think the FDA just told BIEL "you can't use the knee and foot data for a predicate device unless you scrub that data by gender." But who knows -- BIEL management never tells the whole story and never tells us what the FDA actually said, always keeping shareholders in the dark. Their disclosure policies are insulting.

Let's see the rejection letter so we can stop guessing.