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We need some good news soon. Also, some solid updates would be great. Investors like to hear positive news about the company and products moving forward. The PR for this company needs to be more up beat and sent out more often. Once a month is not enough. News travels fast on the internet theses days.
The FDA needs to make an announcement to get this stock off the ground. Tons of potential with Biel.
This is a great board. Everyone has a positive attitude and is here for the right reasons. Have a great day.
Spread the word! It's only going to get better.
Several different price stages. FDA announces reclassification -price goes up. BIEL submits 510k - price goes up. FDA approval -price goes up. Large stores with multiple locations like Walgreens takes on product line- price goes up. In between some price fluctuation. This company has so much potential that it is overwhelming. Think of all the possibilities. I'm thinking large numbers.
Nicely done MFCstock.
Legal tips this information is huge! It states in other words that this will happen. It's just a matter of when.
BIEL needs hire this person to fill out the 510k paperwork.
How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry
With countless forms and steps necessary to get a medical device approved, many organizations become frustrated when a device is rejected from entering the market. And then, the whole approval process starts all over again.
Learn what you need to do to pass your 510(k) submission the first time and avoid costly delays that can wreak havoc on your business.
Regulatory affairs expert Cheryl Wagoner clears up any confusion you may have regarding your application for devices that contain software in How to Achieve 510(k) Application Success For Device Software: Avoid Pitfalls that Could Delay Your Market Entry webinar CD and transcript set.
Calling on her 20 years of experience, Cheryl takes you by the hand and walks you calmly, carefully and expertly through the steps you need to take to move your application forward as quickly as possible. You'll learn answers to key questions, such as:
What makes your software a medical device?
How do you define and support Level of Concern (LOC) determination?
What are the 11 software-related documentation sections you must include in your application?
How is Risk Assessment/Mitigation related to the LOC?
How is software change management related to the LOC?
Do you have to include V&V test reports?
What are two key exemptions from 510(k) requirements?
How do you meet labeling requirements (since there is no place to physically attach a label)?
And much more
Most importantly, you'll take home Cheryl's all-inclusive checklist of items you must include in your application … items that will help ensure the software section of your 510(k) is complete and reviewer friendly.
Put an end now to the frustration of spending endless hours filling out countless forms only to find that your submission has been rejected and you're back to square one.
Instead, turn to an acknowledged expert whose experience — and checklist —will take the guesswork out of your 510(k) application process.
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Next Company Update: Thursday, September 4, 2014
That would be great!
The video was excellent! We are almost there.
The video was perfect! It definitely got the message across.
edbi46 Can you please send it to me as well?
Seven-up great post! It's a pleasure to have you on this board. Everyday we get one step closer. These are exciting times right now. I hope everyone is ready.
3,000,000 share buy. Moved up to .0003
This is great news seven-up. Thanks for sharing and keeping everything in check.
Happy early Birthday! I hope we get some great news.
It is always on the website under investor updates.
Next Company Update: Thursday, August 7, 2014 it looks like we are getting closer. Hopefully the next update will give us a lift. Have a great day everyone!
Up 50%.
Any news on this board.
I'm thinking about getting some shares back.
EVRN looks really good at .0002
We need some Fireworks on the July 3rd update. So we can enjoy Biel Independence Day on the 4th.
I'm looking forward to seeing this take off.
We need some positive news on the next company update.
Bid/Size Ask/Size
0.0018 / 344,100 0.0019 / 7,864,900
Great board today! Also, a lot of trading. The pace has picked up.
Next Company Update: Thursday, July 3, 2014
Great Ground Floor Opportunity! A great man told me once. If it is overseas it will soon be here. Have a great day everyone.
GO BiEL!
I'm with seven-up. Go Team BIEL.
Thanks seven-up for the information.
Thank you seven-up. Have a great day!
Hopefully Good News Tomorrow. Have a great day everyone.
HAVE A GREAT DAY!
GOOD TIMES COMING!
Next Company Update: Thursday, June 5, 2014
Biel is looking better each day. The packaging of the products are perfect size to sell on a shelf. When this gets FDA approved it's going one way. Straight up!
BioElectronics shared a link.
Yesterday
- BioElectronics FDA Status Update -
The comment period for the FDA proposed rule (Docket No. FDA-2012-N-0378) closed on Wednesday, May 21. BioElectronics Corporation has submitted its official response supporting the reclassification to Class II and additionally presenting arguments for OTC allowance as part of that comment. The FDA will now review the comments. We continue to focus on our efforts on completing our clinical trials and assembling the data we will file as soon as the FDA announces the new rules.
We continue to develop our markets outside the US and educate consumers and the medical community inside the US. As part of our ongoing outreach and education program, an interview with a member of our medical advisory board, Dr. William Van der Reis, is appearing in an upcoming issue of Becker's Review, a leading orthopedic journal and on last Saturday he was interviewed about how he's using BioElectronics products on sports injuries in his practice on an ESPN radio show, WeekEnd Warriors, which you can hear at the link below starting at 19:26 into the program. The show is hosted by another orthopedic surgeon, Dr. Robert Klapper, who has invited Dr. van der Reis back to continue the discussion.