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Because I have been told I am pretty smart!!
And when Im buying you better take it to the bank that Whales are paying attention!!! Get it? Didnt think so!!!
As I have stated before I think Novartis is extremely interested in our little Biel!!! (jmo)
Congratulations to all longs!!
What a country! I love this place!!!!!!!!!!
Really????????Opinions vary!!
No MM games today!! Im hearing great chatter!!
Comedy out tonight!!
Who generated the report?
Go to Bielcorp.com
On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance titled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions." This draft guidance released on June 15, 2015, focus on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device’s availability on the market in general. The agency believes that greater transparency about the process and purpose behind such assessment will maximize patient safety by helping industry improve their medical device products and by increasing access to high quality medical devices for patients.
Webinar Details:
Registration is not necessary
Date: Monday, July 11, 2016
Time: 2:00-3:30 PM, Eastern Time
To hear the presentation and ask questions:
Dial in: 877-917-9491; passcode: 8433891 | International 212-287-1619; passcode: 8433891
On the day of the webinar, use the following link to view the presentation:
https://www.mymeetings.com/nc/join.php?i=PW8827733&p=8433891&t=c
Conference number: PW8827733
Following the webinar, a transcript and the video recording will be available at http://www.fda.gov/CDRHWebinar.
Please note the FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.
If you have any general questions about the FDA’s regulation of medical devices, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health
WOW!! Just looked at the closing, had not looked today, .0009
And NO ONE BOUGHT IM EMBARRASSED !!!
Nice find Mac!!
Still here !!
Mac Ill explain how its done Grab one of your fishing poles and duck tape a carrot to the end to keep his attention then......
Hey guys, Mac if you feel uncomfortable doing this for the team, why not demonstrate on your Pet Male Mule!
Same 100m as yesterday!
Hay Robert lots of us old timers know BaaBaa Boo
Very healthy early!
Spikes in sales are just beginning!!!
Once they are bought out 1$ a share plus!!
DB: Remember the trial or try it you'll like was 7$ that might be all we need for a newbee or first time purchaser, Dont you think?
WVC Southpaw: Young and old over react! Period No worries 200k more in Biels System!
opinions vary
15 wiped out
41 million shares traded in 27 minutes thats what im talkin about! BAM
up 74k thats what im talkin about!!!!!!!!!!!!
Where do you come up with 144 million??????
Absolutely Priceless, for all of us that will directly read this!
For all of us true GG&Gs we get it!!
BioElectronics Update
BioElectronics Company Update – June 8, 2016
U.S. FDA Meeting
On May 24, 2016, we met with FDA reviewer for our ActiPatch device, key management from the Physical Medicine and Neurotherapeutic Devices Branch, senior leadership from the Division of Neurological and Physical Medicine Devices, and a Regulatory Advisor, Office of Device Evaluation.
BioElectronics Attendees:
Richard Staelin, PhD, Chairman of Board, PhD in Statistics, University of Michigan;
Andrew Whelan, President;
Ian Rawe Ph.D., Biophysics, Open University, Faculty, Harvard Med School, 2000-2010, Director of Clinical Research;
Kenneth McLeod, PhD in Electrical Engineering, MIT, Post Doctorial Fellowship, Tufts Medical School, Director – Clinical Science and Engineering Research Center, New York State University, Binghamton; and
Attorneys from Goodwin Procter LLP
Dr. McLeod explained ActiPatch’s mechanism of action and presented physiological test results that illustrated how ActiPatch’s nerve modulation negates centralized pain.
Dr. Staelin presented the published musculoskeletal pain reduction data from the Plantar Fasciitis, Post-surgical Acute Pain, and the Osteoarthritis of the Knee studies along with data analyses that followed FDA recommendations. He also reviewed our Customer Assessments of 11,250 users showing the effectiveness and safety of the device without a healthcare practitioner’s involvement.
The FDA’s position is that the ActiPatch has a new intended use because we are requesting over-the-counter (nonprescription) status for the device and this would involve a different patient population compared to our predicate device. The Agency’s concern is the ability of the patients to determine the origin of the pain without a physician being present. Therefore, the agency representatives stated, the de novo classification pathway would be more appropriate for the ActiPatch than the 510(k) premarket notification review process.
Dr. McLeod stated that the risk situation would be no different from that of a person taking Pepto-Bismol for an upset stomach when the underlying condition is really appendicitis. He added that Pepto-Bismol, and other products, can be sold OTC because they have labeling regarding discontinuance if there is no relief within a specified time. Users know whether they get relief from the product and will see a physician if the condition persists. Mr. Whelan added that there are much riskier devices, e.g., TENS devices and heat wraps that are sold without a prescription. Dr. Staelin pointed out that our customer assessment data show that consumers discontinue using the product if it does not provide pain reduction.
Our attorneys responded that:
OTC switches have been done for over 30 years in the context of 510(k) submissions and that the 510(k) pathway is appropriate and available;
There is no new intended use; instead, there is a new indication and the Company can support an OTC switch by submitting information showing that the product, when sold without a prescription, is as safe and effective as the prescription predicate; and,
Any concerns regarding a difference in patient population can be addressed through labeling.
The meeting ended upon the FDA’s management committing to review the information and slides presented during the meeting, and to address the two regulatory issues: (1) the regulatory pathway (510(k) premarket notification or de novo submission) and, (2) the applicable timeframe.
On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary.
BioElectronics Social Media
opinions vary!!
thanks 4 selling me at .0009 today whoever u r!!!
Priceless!!
1.10$ purchase of 1000 shares ridiculous!!!!!!!!!!!
JOHNY: At times I thought I pretty much new everything, but what you found is something I never would have thought of!! ... Nice find!!
GGG's its a start thoughts?