Something else many have overlooked, "conditional approval" = "approved" with conditions, to maintain post-market approval.
That's CE approval and ...
There's no such thing as "conditional approval" as in "will be approved if ...".
That's CE not-approved/rejected. Feel free to try again if you collect acceptable safety and efficacy data in the future ...
As I understand/interpret the IDE announcements, the 20 patient pilot/safety IDE study will provide safety info for OSL used alone. If a sufficient safety profile is demonstrated, permission will be granted to proceed to randomization for controlled comparison.
Only the randomization phase can produce scientifically and/or statistically valid efficacy conclusions to support a new/revised CE application.
Gonna be a long road, a true case of the path you pave is the path you walk.
Good luck all.
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