Replies to post #92293 on Bioelectronics Corp (BIEL)

[seven-up]

Good deal thanks for sharing Dufresda

[lizanne1890]

I heard similar news. glad we are getting this show on the road go biel!

[60cent]

Dufresda - sorry can you just explain your first sentence "They are already FDA approved they are waiting for over the counter sales clearance from FDA, limited to prescription sales."
So - are you saying you've been told they got OTC clearance from the FDA??
What do you mean by limited to prescription sales - doesn't OTC mean the opposite - ie. that you can buy over the counter WITHOUT a prescription?
Apologies if I'm just misreading your post.

[srinsocal]

Thanks for sharing your info Dufresda

Great to hear that Knee and Foot are in the bag! AW does, IMO, need to mark his calendar with a drop dead date for a full Musculoskeletal Clearance because, as we have seen with our 90 day 510k that is now at day 525, time means nothing to the FDA.

The Long Suffering BIEL Longs are in need of an FDA Win even if it falls short of full body Clearance. People are resourceful and when ActiPatch eases the pain on their sore knee they will try it when their back or shoulder flares up. Take what the FDA is giving and use the profits to continue the pursuit of full Musculoskeletal.

Shareholders do need an official FDA Update from the company as it has been 3 months since the 10/10/2016 FDA Status PR. A phone conversation with Ed is helpful but not the same thing as a written statement.

I can understand waiting until after the holidays as people are traveling and distracted but we are 11 days into 2017 and a FDA/SEC status is appropriate.

[GetSeriousOK]

Here's what Ed Whelan needs to tell us.

Release a Company Update or Press Release, Ed, and state in no uncertain terms: is the 510(k) still active, or has the application changed to de novo?

No more of this Safe Harbor "we submitted a 510(k)" smoke-and-mirror hype. We know you submitted a 510(k). We want to know the FDA's "pathway determination." We know they told you. Now tell us.

Also, Ed, what did BIEL file with the state of Maryland a few weeks ago if not a R/S or A/S increase?