FDA Plays

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Biel Update From Joe Noel
Everyone:

Here is the latest on BIEL. Sorry not to be able to respond to all your messages - Have about 100 between Tuesday and Today.

FDA - We have a meeting with FDA ONE WEEK FROM TODAY!!!!!! We believe the hold up on clearance is a classification issue. We are a Class III but we have applied for reclassification. We think FDA is holding clearance until we are reclassified to Classs II. The big news is FDA has invited us to a meeting on Friday of next week to discuss the isuse. We are hoping this will resolve things. Very exciting!!!

Tylenol Study - IT IS DONE. SHOULD HAVE RESULTS NEXT WEEK!

Direction of the Company - Monday was a huge day for BIEL. For the past year I have continued to tell you that the priorities of BIEL are 1) clinical trials, 2) FDA clearances, and 3) building the brands. On Monday we finalized our marketing plan - BIEL's priorities have now changed. It moves BIEL to a new chapter in its corporate life. It is now one of revenue generation. Over the next few months you will here a lot about this new chapter of rev generation. Also will hear a lot about our entry into Japan and the domestic and international TV ads we have designed - very classy and high quality.

None of us at BIEL have lost any confidence. We feel FDA clearance is not a matter of if - only when - this meeting with FDA next Friday should be very interesting and we hope the event that breaks the log jam. Joe Noel