Rocko, I am a Clinical Research Associate contractor and work with both drug and device sponsors. Yes, the FDA does give input/direction and parameters for the study protocols. Titan has said countless times they have been working directly with FDA. Yes, it is expensive but its a necessary and expected cost of development. They do not have their own research operations staff so they will most likely need to hire a CRO or FSP to conduct the monitoring of data. It will be a simple, straight-forward protocol. They will use the sites they already have a presence in and surgeon/investigators they already have considerable experience with. It's not that big of a deal.
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