Bioelectronics Corp (BIEL)

[Simpsonly]

As Robert de Niro said in the movie Dubb10 - "you're good, you're very good"

In my opinion, this is exactly how the FDA has tried to save face.
Look at the timing - the large 20 person plus meeting with BIEL management and bio-physicist was June 8th was it not? So, one month later FDA publishes this? It establishes a set of guidelines - rules if you like, under the heading "Additional Requirements" and declares costs per trial participant? Is this course change in mid-stream a by-product of the clarification meeting with BIEL? If it tightens the process for the sake of safety, fine. If it impinges on BIEL, not fair. C'mon, this is face saving and parental 'here's how you do it' stuff. I hope the FDA has thanked BIEL for the clarification. This is more than coincidental folks.

The issue now is where does BIEL stand opposite the new 'Additional Requirements' of July 9. Should BIEL management bill FDA for assisting in the establishment of regulatory protocols on a product line FDA is unfamiliar with - a guinea pig fee? Life does not work that way.

I see this as good news that the FDA is in the game. Again, well done Dubb10 - thank you!