FDA Plays

[colorofmoney]

Update from Joe Noel 16-Nov-09 06:47 pm
Here is the latest update:

FDA Meeting - I did not attend the meeting so I have not wanted to provide the update. Have been told by management that management and the lawyers were at FDA on Friday. Was a short meeting to discuss reclassification from Class III to Class II. FDA asked for additional information concerning power levels. Another meeting has been set in about a week and a half where management is going to provide data from a scientific study that was done by Dr. McLoud out of Stoney Brook University. Sorry I do not have the date - management is in europe working on a distro contract so I do not have all the details. The scientific study should provide additional info to support reclassification. Everyone thinks the fact that the parties are talking is a very good sign - if FDA was not going to consider we do not feel we would get in front of them.

Study - What can I say about the study that has not been said. I think the result speak volumes about how effective ActiPatch is - I know as I have used the device myself after my skin cancer surgery. The study data is being sent to FDA and will probably be used as the basis for an additional filing for muscle soreness. There are now four studies showing safety and efficacy.

We feel things are progressing well at BIEL. The next stage of the company will be revenue generation. I think all of you wil be impressed with the upcoming marketing plan. Thanks for all your support.