Bioelectronics Corp (BIEL)

[Simpsonly]

Hey Dubb - amazing post - thanks very much.

Could this snafu at FDA be as simple as a misunderstanding of the issues and data brought about by inexperience or sophisticaion with respect to the product? When FDA explains that it is having issues with "turnover and budget fluctuations" - what the H are budget fluctuations and how do they affect the talent and expertize pool on devices? That double-speak tells me they ain't got the talent in place to properly assess the widget applications FDA is getting, particularly on PEMF and other devices. These are not drugs, so a different skill-set is required?

How can FDA assess PEMF and new predicate devices if it doesn't have the best and the brightest assessing the technology? PhD's in various disciplines of chemistry cannot do this. Plain and simple.

The acknowledgement that FDA "may need to tighten up some aspects of its approval process" leads me to suggest it stop any approval processes it may have to tighten up, instead of what logic tells me they are doing, which is therefor winging it. If you have to tighten it up, means it is sub-standard = guessing and winging it! And if FDA is winging it on the rejections, it is also winging it on the approvals, which is placing the public in harm's way. So, stop until you have the talent in place and competent.

Imagine the costs of winging it on FDA, applicant companies and the public, please, let's not forget the public which uses or does not use drugs and devices on the say so of a system that needs tightening up?? "May need to tighten up some aspects? Amazing, just amazing..... Time to use the philosophy of Delta Force members - we don't do something over and over until we get it right, we do it over and over until we can't get it wrong!