that was fda. But more interestingly RAP submitted final docs for a CE mark beginning of Feb 2019 and GOT THEIR APPROVAL August 2019 or 6 months later. Better settle in cos the earliest that we submitted was early jan so assuming same complexity (which is a bad assumption because OSL is more complex) we are looking at mid June approval. Only silver lining here is virus hysteria might be a thing of the past at that time.
that was fda. But more interestingly RAP submitted final docs...
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