Replies to post #52655 on Bioelectronics Corp (BIEL)

[ddls]

Yikes!!! another bad move on BIEL's part.
I shall have to mark this post on the BIEL calendar.

" We have filed a request for clarification to determine if we should continue to use the pulsed shortwave classification of our devices clarified, we have decided not to wait. We do not foresee adjusting or resubmitting the application to accommodate a different FDA action."

Can you just see frustration biel must be going through? But, I thought they were selling like hotcakes around the world!

[Lizanne1891]

thank you seven up I find this very helpful.

[ddls]

I wonder how long the CEO will set on the FDA denial before he tells anyone this time?
Any time frame calculations on that?

[ddls]

No-Value In-This Announcement By-BioElectronics As With All Others.

[srinsocal]

It looks like AW opened his wallet for legal services on the 510k this time around. This should be a quality submittal with Goodwin Procter involved.

Goodwin Procter’s largest office is located in Boston at the heart of the city’s financial district. We are the second largest law firm in the city, with over 450 attorneys. Goodwin Procter is a leader in civic, community and philanthropic efforts. Our practice is evenly balanced between business law and litigation. With particular strength in corporate, litigation, real estate, private equity, technology companies, intellectual property, financial services and products liability/mass torts, our attorneys represent some of the nation’s leading companies in complex transactions and high-stakes litigation. These practices are well-supported by specialty teams in tax and ERISA, as well as trusts and estate planning, environment and energy. Our clients range from emerging enterprises to the largest national and international institutions.

With a full-service team of attorneys spread across offices in Boston, New York, San Francisco, Silicon Valley and Washington, D.C., our Technology & Life Sciences attorneys help clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle.

We work with more than 1,000 technology and life sciences companies, 200 venture capital and private equity firms, and many of the leading investment banks worldwide. We take pride in understanding our clients’ businesses, share their entrepreneurial spirit and drive, and provide counsel in connection with company formation, venture financings, intellectual property protection and transactions, IPOs, mergers and acquisitions and other corporate matters. Our industries of focus include software, hardware, online content and commerce, IT services, clean tech, biotech, pharma, diagnostics, medical devices and healthcare IT, among others.

Illustrating our attorneys’ dedication to clients in these sectors, Goodwin Procter’s Technology & Life Sciences Group is frequently ranked among the most active legal advisors in the industry. U.S. News-Best Lawyers recently recognized us as “Biotechnology Law Firm of the Year” for the third year in a row. Bloomberg, BioPharm Insight, CapitalIQ, Pitchbook, Private Equity Analyst and PrivCo each ranked us in the top five most active firms for technology and life sciences industry venture financings, technology licensing agreements, IPOs and M&A exits.

[DDGUY]

I saw that but it's a waste of money -- without the final order they have to go based on the guide line fda has to use ... They should just wait for the final order as the FDA indicated in the order ....

[NoPinkScams]

What a ridiculous filing. There is no point in filing this prior to the reclassification because the FDA isn't even going to bother looking at it until that process is complete. The FDA made it very clear in their panel discussion and the proposed rule that only scientifically sound clinical trial data would be considered and only for specific indications so the recently published survey results won't even be a consideration.

The proper course of action would be to wait until the final order is published and then apply for class II approval for Osteoarthritis treatment based on the results of that study. The rest of their studies have already been reviewed and dismissed by the FDA as flawed. During the meantime they could continue their European and Canadian marketing push.

This stinks of a PR stunt and brings back unwelcome memories of the Joe Noel days.

[$treet Trader]

in some BIEL .0008 on 510(k)
BioElectronics Files 510(k) Premarket Notification for ActiPatch® Therapy with FDA
We are pleased to announce we have filed a 510K Premarket Notification for ActiPatch® Therapy with the US Food and Drug Administration.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116012391

[Simpsonly]

I'm sure I'm hours behind the Good Guys 7up - looks as if this needs a couple of edits. What do y'all think?
Maybe someone was sipping Yamayama before they gave the text to the webmaster to FTP onto the web?