Completely agree. In fact Carrick addressed this in the investor presentation. As part of the study protocols they were not allowed to offer financial inducements to participate. To pay for their flights and hotels after the study ended would have constituted a financial payment and thus prohibited. The one thing they were allowed to do, was keep the Mente device. And we haven't seen too many of these returned so it suggests these families are very happy with how it is performing.
At the end of the day, an independent study as per the trial protocols was required. This has been completed, the results successful and those results now presented to the FDA as per the submission through Emergo. Assuming the FDA doesn't have too many questions and there isn't too much to and fro, we could actually see FDA granted relatively quickly on a Class II medical device. But there is little point re-hashing over old ground around the study itself. Its done. It worked
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Completely agree. In fact Carrick addressed this in the investor...
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