Replies to post #19110 on Bioelectronics Corp (BIEL)

[uksausage]

it is very simple

the US FDA ensures both the safety and the efficacy of new devices

other countries are just concerned about safety. So you can scam anyone around the world saying your device cures anything so long as it does no harm. US FDA approval means it actally does what it claims.


the rest of the mumbo jumbo is all bout different processes IMHO had AW known the de Novo would take this long he would have done different approach to get Rx for more treatments and even Allay separate from Actiptch. Now everything is I believe lumped together and due for decision "in a few weeks".

[GoldenBull]

Hey Simpsonly, great questions and to the best of my knowledge I could only agree with uksausage, because I don't want to be providing you with only my assumptions and not logical reasonings. I do not know the exact reasons, but in my opinion, I would say the bars/standards are set differnely in each country. If I remember correctly, it only took Health Canada 14 days to approve BIEL's products in Canada. But for your peace of mind, in my opinion, you could try and research Health Canada to obtain BIEL's approval letters/documentations.

Hopefully other better informed investors regarding to this matter, like uksausage or imrich (who works in the clinical trials' field relating to the FDA), could provide answers to this question.

All in my opinion.