Tuesday, April 17, 2018 6:32:58 PM
Annual report 2017 Fraunhofer IZI.
N.I.C.E appraisal UK.
Maybe you can add this 2012 quote of Linda Powers to your list.
INTERVIEW WITH LINDA F POWERS (2012)
"JE: So that’s in the United States, an FDA approval process. The European, Germany and London regulators will have to approve by their respective regulators for use in those countries as well?
LP: That’s the objective. But how the system will work – and this is a really important part of our strategy is this; it’s the same trial. We are simply adding the European sites into the same trial that’s already underway in the US, rather than doing a separate parallel set of trials in Europe. That’s really important for several reasons. First of all, it saves us a lot of time on the front end; more than a year but that’s not the key. They key is that by being all the same trial, all the data is going to be pulled together. All the data is going to be presented, when the time comes, in an application for product approval in each location. In the US, we’re going to include both the US and European data, and in Europe we’re going to include both the US and European data, and it makes it a very strong package."
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