FDA Plays

[colorofmoney]

BIEL On Today's Study Results
Everyone:

We consider the study data to be very big news. The data is excellent showing strong statistical significance. There is every reason to believe the rest of the data will be just a strong. Showing that ActiPatch works better than Tylenol will strengthen the case for clearance and will be huge relative to marketing claims. All of us at BEIL consider this initial data one of the biggest events in the life of the company. The investigator needs to be conservative in statements until the entire study is completed, but this is really strong data the FDA will have to take into consideration.

Take a look and listen to what the FDA is now saying about Tylenol and then consider its choice relative to a new technology that is shown to work better than Tylenol. We think this data makes our case toward approval significantly stronger. Here is the link to the FDA's official position on Tylenol.

http://www.fda.gov/Drugs/ResourcesForYou...

Listen to the audio clips - we think they are pretty amazing as is this study data. Joe Noel