Wrong. Nobody is saying there is no data and this may be a decent device. What is being quite reasonably raised is the way in which that data have been presented in these materials to look much better than the reality. We expect any biotech company to want to show itself and its data in best possible light and apply bit of spin especially when it goes cap in hand to market but I’ll stand by my opinion that the comparisons being made amount to blatant cherry- picking, in fact sadly some of the worst I’ve seen in this space. You only need to check out some of the misquoting from references to see this. The FDA has awarded a designation that’s true, that’s not same thing as an approval. Let’s see their PMA trial design first.
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