Going by their previous track record in gaining CE and TGA approval, plus the fact gaining De Novo classification over 12 months ago and throw in our own Federal Government endorsement and support I hardly call it ramping but base it on fact. In your opinion FDA is not guaranteed can easily be construed as down ramping, as opposed to my opposite opinion,besides my disclaimer always states its my opinion only, just like you have your own. Get off your high horse champ.
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