Replies to post #130864 on Bioelectronics Corp (BIEL)

[pearsby09]

Imminent means any day (Back clearance). This is far from imminent. May 9th is the meeting..then months after will be a decision. Getting closer might be a more accurate way to put it. Just keeping it real here!

[art2426]

Yeah Simps, the FDA meeting with representatives of Bioelectronics cannot be construed as anything but POSITIVE. Nobody is wasting their precious time unless they all see a final conclusion to these clearances with most likely a couple of items to be ironed out for the inevitable BACK and FULL clearance. "Let's get the wording right on the packaging and instructions for restrictive use and warnings", is how I see it going. I am getting deja vu all over again (one of my favorite Yogi Berra quotes), as I recall all this conversation about prior meeting the company had with FDA and guess what? --- They approved the knee and foot shortly afterwards. And I am expecting the same result from this similar situation.

[walker_429]

The advice in the post related to Biel and the FDA is completely BULL CRAP

There is no specific Clearance for Back LMAO ..... There would be a general Full Body OTC Clearance given which of course will include the back, shoulder etc. Biel will be able at that time to do labeling accordingly.

Just curious for those of us who unfortunately have no idea about how the FDA regulatory process works....What would be the so called back clearance medical term ? Lower Back Pain?

[DewmBoom]

Absolutely. However, they could have saved themselves and Biel some precious time had they granted Biel clearance on everything more than a year ago.

All is good here. The past is the past.

Cheers!