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was-pennygold

09/03/10 12:04 PM

#11803 RE: alexander77 #11802

I think Tuesday looks very good (I think the market is closed on Monday). I also think time is running out for BIEL in this low priced penny range. In the letter from the president of BIEL, looking at the last paragraph we can see there will be more positive things happening within the company this fall and especially by EOY as expectations are running higher:

Letter from the President

August 9, 2010

A Letter from the President
(Skipping to FDA part of letter):
Many of you have called and e-mailed to inquire about the pending FDA clearance status. We have filed two U.S. FDA 510(k) market clearance applications for the OTC ActiPatch and the OTC Allay Menstrual Cycle Pain Therapy devices.  While the FDA responded with “Not Substantially Equivalent” letters for both products, the rationale behind their response is that the current “pulsed electromagnetic” product category applies only to post-operative devices.  However, new testing and documentation establish that our devices are athermal; hence, they do not belong in the FDA’s “pulsed electromagnetic” category, which is otherwise defined as “Diathermy” (heat-producing product).  Our products are unique and better defined as “Electrical Stimulators” (rather than diathermy devices).  To clear our products as a unique category, we have filed a Section 513(f)(2) petition (also known as the DeNovo process).  We have also developed a modified device for which we plan to submit a new 510(k) request.   Either way, we are certain that FDA clearance is inevitable and close.
(Skip to closing of letter):
Moving into fall 2010, the future of the company looks bright.  Between our expansion into new DRTV markets, new product developments, and our dedication to gaining FDA approval, we expect big things from the end of the year and plan to carry that momentum into 2011. As always, BioElectronics Corporation thanks you for your dedication and support.

Sincerely,

BioElectronics Corporation

Andrew J. Whelan

President

P.S. To be added to our Investor Relations Newsletter list, please email your contact information to IR@bielcorp.com or if you are in the neighborhood, come visit us.

Patient Testimonials
"For years I've been using Tylenol for my menstrual pain.  Then I discovered [Allay].  I'm now really happy using this product instead.   Thanks for developing this great product!"
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Roberto7

09/05/10 8:54 AM

#11806 RE: alexander77 #11802

Monday Labour Day ^^