B745
Based on all the studies and scientific publications, it is a bada$$ little device. The hold up is based on CASCADE was an OUS Study. The FDA has been working off draft guidance since April 2015. Amedica's data from CASCADE submitted to the FDA was considered adequate and under 21CFR 860.7, supported valid scientific evidence.
The delay has never been about whether or not the FDA deemed CASCADE data scientifically adequate, rather intermediate time points and specific subsets. Through the wonderful world of statistics, AMEDICA has provided the FDA what they required.
An often overlooked aspect of SNAP, it to is an OUS trial as well. However the beauty of CASCADE isn't sole singular device approval, it HAS provided a blueprint for FDA approval.
When my friends and I conduct research, we exploit all weeknesses and leave no stone unturned. You listening Frederick???
Master of puppets I'm pulling your string...
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