Replies to post #19117 on Bioelectronics Corp (BIEL)

[uksausage]

As you state Canada's "Our highest priority in determining the balance is public safety"

FDA's priority appears to be efficacy. No other body requires bench tests to prove how the technology works.

There is no way Canada in 14 days can be proving anything apart from reading the documentation a company sends. US FDA is IMHO way over the top here but someone asked about why there is such a difference and IMHO it is the efficacy proving how something works that matters.

In this case we are setting the criteria for a new device category which has extended the timeline.

From what we know there has been no contact (apart from "any news" calls) sine early December so the 80 day timeline is ticking.