So now we wait again but at least we know we are now waiting on FDA to make their decision. Question now is how long will it take? two weeks a month or more? Any one have any experience with the FDA on how long this will take?

So now the question is how long will the FDA take to review and make a decision now that the 510 is filed?

NEWS:
BioElectronics Files FDA Application for Treatment of Musculoskeletal Pain
8:30 am ET July 12, 2018 (Globe Newswire) Print
BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch(R) was filed today with the U.S. Food and Drug Administration (FDA). The market clearance requested was "over-the-counter adjunctive use in the treatment of musculoskeletal pain".

While ActiPatch is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints. Full details about the study can be found at the NIH's clinical trials listing page: (NIH Back Pain study link).

The 510(k) was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who spearheaded the 510(k) effort, said, "We are confident with the strength of our data and overall application. Given the FDA's prior knowledge of the data and prior clearances, we believe that the 510(k) will be processed in a timely manner."

Keith Nalepka, VP of Sales/Marketing, remarked on the market opportunity: "An expanded market clearance will make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with musculoskeletal pain."

About BioElectronics Corporation

BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch(R) Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx(R) Devices for chronic and post-operative wound care; Allay(R) Menstrual Pain Therapy. For more information, please visit www.tryactipatch.com

Paul Knopick
9402623584
pknopick@eandecommunications.com
https://resource.globenewswire.com/Resource/Download/99ac74c2-fe4b-4e40-93bf-dcbb108b59d0?size=1

You just got your answer.

That's good news.

Sure I would like to have PR's to have more communication. However maybe what they are working on right now are such company changing events that they don't want to do anything to jeopardize screwing it up.

We know Keith likes to tweet so the fact he isn't on anything major is more like a gag order until deals are finalized.

Since I have no idea what is really happening this could be just wishful thinking but this makes sense.

We shall see. I will admit though I am filled with anticipation and doing my best to be patient.

Hope this turns out to be what most of us believe it will be.

Bobby I at least want to have the choice and ability to buy a Ferrari.

Yes they do work. They are actually little miracle devices. My wife is using one right now. That's a good way to take it however until that green light is given we just don't know. There could be more to it like politics and big money getting in the way.

hmmm interesting...

very interesting...

Big statement...

no longer imminent?

Do you guys see on level 2 CDEL has an ask in for 98,773,433 at .0026.

Looking forward to those events happening. At this point it's like watching paint dry waiting for updates and news.

Nice post! I wasn't aware of this. at this point we just need Patience... it's going to be great!

Here's how I see it. Announcing Sweden without any supporting numbers to substantiate what profitability that's add add won't do much for investors interest. It's great sure but what does it mean? They just sit on the shelves and maybe get prescribed.

This is all so new to the company and the world that I don't believe they know what those projections are yet.

What will be nice is when they can release news with more detailed substance in it. Somethings like 5 million upfront cash invested into BIEL by Dr.Scholls partnership to cover immediate product ramp up etc. Dr. Sholls sells currently 10 million smart insoles annually and the majority will have the actipatch in them. Expected revenue for the first year to be in excess of 5 million.

Now that is a monster PR!

Do PR's like this ever get released or am I just dreaming?

One of the things I pleased about is the ruling is what has been said on this board for awhile. That adds a lot of validity to what is said here. I realize we don't know yet how this will affect BIEL however good stuff.

So what is the implication of this and it's affect on BIEL?

Very well said Art. No one is shaking my shares away. I believe this is going to be massive. With the progress already in 2018 we are in great shape for what's ahead.

There's going to be ups and downs but doesn't matter this is a monster about to be unleashed.

Not sure... does anyone know how long it will be before we find out what this means?

I am thank you. IMO you should jump in now.

You're gonna miss it.

There was no run yet. This was just a slow and steady increase based off of accumulation. If you would do your due diligence you would already see that. Thanks for proving my point that you are just spouting information without the facts.

Well i'm up 200% and all Freebies. If I'm been played i'm happy as can be.

Please I know many investors and we only want more shares. You have been on this board for a few days and spouting as if you have any idea what us longs really want. I'm bought in the trips and what I know is we are loving this.

We are just in the beginning of a major growth cycle. Small business turning into a giant one.

Sure we have many obstacles ahead and we know the PPS is going to fluctuate but again we haven't even begun the run yet.

the foundation for true growth is just being set now. I'm thinking in the next few months there will only be that much more of a foundation laid for future revenue and growth.

better get in now or you will be regretting it forever.

Those look great. Those bandages were a pain to peel.

9 mill purchase ready on .0038 plus another 2 mil showing on L2 good size purchases

Sorry I'm trying to catch up here. What are you referring to? Where is or was the "Breakthrough Product" mentioned?

So lets say sales are 5-10 million on the next financials. Where does that put BIEL regarding showing revenue and future outlook?

In investors eyes how will that look? Compared to all financials in the past I see that putting BIEL in the black with a huge potential for future growth.

Thoughts?

Oh I didn't get what that meant when I first read it. That's FANTASTIC!!!

Another country paying for Acticpatch. This is amazing, As each week goes by I believe more and more how this company is just an enormous monster waiting to be unleashed.

Need that FDA approval though... Bayer, revenue and everthing else.

Waiting patiently...

Hopefully that will at least make sense to you...

What I like about this PR is the partnership for one with a huge company worldwide but also is that it provides a specific number of 7 acticpatches provided for each surgury. That allows for immediate calculation of revenue.

Hopefully this is one PR in the long line of many many amazing ones to follow.

Oh boy! Will investors understand how big this is?

Spinal surgeries also coming? WOW!!

I have been thinking the same thing.

Big stuff going on and we don't know anything regarding status of it.

They are doing a good job of keeping things under wraps. He mentions on twitter a tidbit of positivity about B.Braun. Anything specific... Nope.

just waiting patiently for when it all starts happening. This week would be nice!

Based on this it would seem getting full FDA approval for the Acticpatch should be a no brainer.

All misleading information.

Hey that's awesome your in Rockland. 30% of BIEL?! Whoa...

I'm waiting for the .18. Who knows if all this goes through we could be there and higher. Would love to be doing the happy dance watching this stock soar higher than I imagined.

Then I believe 100 is an average day for you.

Awesome love the doors but don't hear that song very often.

My pool is over 70 but will be over 85 soon.

Sacramento California almost 100 here today.

I am thinking they know much more then they are letting us know about right now. Let's get this party started tomorrow! Lets hit that penny, nickel and so forth.

I think that's a big statement to be said even before anything is announced. Very exciting times ahead!

Who cares about a tick or two, meaningliss. With what's to come, this is fantastic we are sticking around the three's. If you are a day trader than staying the same where we started might be frustrating.

This is a monster and by the end of Dec 2018 we should be at a very different PPS.

WOW that's impressive. What a great time to be sitting on a bunch of shares.

Hope all of this comes to fruition or most of it in 2018.

Plus I believe there is more we are not even aware of as well.

AMAZING!