Why would a trial conducted in Europe be so inferior? Is it the lack of ethnic diversity?
Doesn't FDA approve parameters of a trial before commencement?
The idea of FDA clearance seeming like a sure thing has to do with the process. FDA has received all the data, data is good. They made it through the substantive review with no major issues and they worked through the minor ones in the interactive review.
At this point, if FDA were to deny it would be simply because the trial was conducted in one of the whitest parts of Europe. This same problem could arise if they ever attempt to clear CsC in China.
I remember seeing Aug 16th date for FDA in regards to this. I think aaaaasp posted that sometime ago.
Anyways, for comparison a company by the name of Vertera Spine 510k, with a Porous PEEK cervical device also took this long. Filed: 12/24/2014 Cleared: 9/23/2015 - 273 days later. Amedica is on day 273 as of today. Not sure if this has any meaning, but this was the closet comparison i could find to what Amedica was trying to do with CsC.
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