FDA Plays

[colorofmoney]

Biel - Why this study is so important - Joe Noel
Everyone:

This study is important for three reasons:

1) It adds further support to out current 510(K) applications. We will present the data to FDA during our meeting with the department director on Friday. We have now completed four studies showing efficacy and have a separate scientific study on the technology. We have sold thousands of units worldwide and have NEVER had a safety issue.
2) The Study has a dual focus - efficacy of ActiPatch and comparison to Tylenol. As most of you know, FDA is adding to its public information campaign to inform the public about the potential dangers of Tylenol. We at the heart of this debate.
3) This new study could easily be used as the basis for an additional 510(K) filing specific to delayed onset muscle soreness (DOMS. We have not yet decided, but it is an exciting option.
4) This study will also enhance our marketability internationally. We are preparing to launch Japan and China, both of which are very exciting markets. Stay tuned.

Joe Noel