JUST FOUND THIS ON ANOTHER BOARD
Update from Joe Noel 15-Oct-09 11:31 am
Hi Everyone - We have been getting too many calls and e-mails to answer over the past few days, so I thought I would provide everyone with a quick update. First of all, all of the loyal BIEL shareholders should know that there are a considerable number of outright lies posted by some of the bashers on this board. Here are the facts relative to FDA clearance. Don’t let the basher and liars take your shares from you.
FDA status - Last week we heard from FDA on the second set of applications that were filed. They had only two questions for us - one of which was to provide a simple diagram - we and our FDA lawyers consider this to be a very strong sign. Meaning, having only a few questions from FDA indicates there are not major problems with the applications. Many filers get dozens of questions. This strongly reinforces our stance that FDA clearance is highly likely. After all, the FDA has been saying for more than six years that ActiPatch can be used on a plastic surgery patient’s eye. We see no reason that they are going to say that it cannot be sold for someone's knee or back. Safety is 100% and there has never been a single complaint ever raised. Efficacy is very high, which is demonstrated by very strong clinical data generated by Dr. Genecov. We maintain our strong opinion that FDA clearance will be granted. It appears FDA is somewhat backed up on 510K applications after moving their offices and getting a new director of the device unit. We don't have an estimate of when clearance will be granted, but we do believe we are getting very close. Our opinion internally is that we will be able to market the product over-the-counter very soon and we are now shifting gears at the company toward this aim.
The October 15th date that has been thrown around was arbitrarily set by the people at a newsletter called BioMedReports. It was never a date provided by FDA or BIEL. Everyone needs to understand that the FDA will act when they act. The FDA's mission is to make sure that products are both safe and effective. Their mission is also to clear devices. Historically over 80% of all devices are cleared. Being cleared for one indication of use by FDA combined with the strong efficacy and safety data all certainly point to OTC clearance for our products. We continue to believe FDA clearance is right around the corner.
By the way, the Tylenol study continues and we are looking forward to reviewing the data.
Everything is fine. Our confidence level in the future remains sky high
