Bioelectronics Corp (BIEL)

[2Relax]

https://www.npr.org/sections/health-shots/2019/03/04/689739642/fda-tightening-regulatory-requirements-for-some-medical-devices

This just came out this morning. More reasoning to have the dream team discuss the 510(k) with FDA.

Because of the fact that top tier at GP used to be top dogs at FDA is the very reason we need that type of top tier representation. Simply put, these TOP TIER attorneys can have discussions that our team just cannot have simply because they dont have near the experience needed to have those types of discussions.

When the FDA said that they see this works better on women v. men, (I wish GP could have taken that opportunity to talk back to the FDA in a more appropriate tone) questioning how they came up with that, and then they can lead the conversation from that point. We simply cant do that without that type of experience.

That's how the previous 510(k) would have gone and the results IMO would have been different. We would be on the path to make money.

Without them - just spinning our wheels why they continue their trial and error strategy. Many missed opportunities that we simply cannot afford to miss, but we still are because our leader has a new strategy this time.

Frustrated, just my 2 cents.