what's next, page-3

Don't get ahead of yourself revreboot, the statement was.. "The final piece we need for CE Mark is the validation data from our new, larger scale manufacturing process and this will be available during December 2011.”

My reading of this is that the validation data is the final piece of evidence required in order to get approval for sale.

When they get this info, they can submit the application.....

Knowing TIS they probably won't even announce they've submitted the application.