The whole FDA process has been clouded by confusing and at times "not completely true" statements coming supposedly from teh company - especially back when Joe Noel ran the IR side of things.
If you look back to the statements from Andrew Whelan about the actual filing dates of applications, FDA responses (both unofficial meetings/calls and formal letters you will see that a lot of the delay has been on BIEL's side of the equation.
The whole process is at fault as anything that wasn't invented by 1978 has to apply, be rejected and then apply through the De Novo process for a new category of product. This has to then set the standards for any similar product in terms of defining the classification, the labeling and other measures necessary for class 2 or class 1 sales.
We are now in the final stage, but BIEL took 2 months to get their last information together.
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