Biel Update-Joel Noel
Lots of worried investors here and I don't blame you. Got a Call from Lady V a few minutes ago and she asked to address a few concerns. So, here goes.
First off - Everything is fine. We are adding a few last minute important enhancements to the 510Ks - Here's the story - As of early this week the file was really very good, but it was not 100% perfect. We only want to file an application that is perfect. Over the past week we enhanced the application with a usability study that we just completed. This enhances the OTC part of the application. We could have gone without it, but we have selected to include it. I think it is the right thing to do. We are also adding to the file two medical papers about the affects of ActiPatch on cells. These are written by Genecov and one other MD - both of whom have many years of clinical trial experience. This will further enhance the file. We have made the choice to take a few extra days to add this info - it will make the applications much better. We want to give the FDA reviewer every tool available to give us fast clearance.
We have also taken a few extra days to have our law firm review the application one last time. This too is a wise management decision. The lawyers say this will be a very strong submission - every "I" is being dotted and every "T" crossed. We feel this is too important to rush out the door.
The final product will be a very strong file that we feel willl have very high odds of clearance. In the past, some have critized BEIL management for being a bit careless about procedures and to some extent this was correct. Now, however, we are taking the extra time to make sure everything is perfect and I am confident it will be. We are very confident this application will be successful.
Some will critize us for the delay, but I remind you that BIEL is a very small company - we are not Pfizer or Merck. A good percentage of the team has been pulled away to take care of the information request from pink sheets. The rest of us are finalizing the 510K. It will pop out of BIEL over the next few trading days. Everyone needs to hold on and have some patience. Taking a few extra days makes sense.
I will close by saying that I have been involved with BIEL for well more than a year and know this story well. I have never been more confident in the company's future. I believe the file that will go to FDA will be stellar - we have taken the time to do it right. The clinicals are very strong and safety is 100% I also believe, as do our FDA lawyers, that odds of clearance are extremely high. It's coming - sit tight.
Joe Noel
