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J-Rhino

12/26/10 10:42 AM

#12718 RE: Ten4 #12717

Helps with validation for the FDA, if they can get 500,000 unit sales with a safe record in Europe, it will help their case with FDA approval.
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Brabo

12/26/10 2:01 PM

#12719 RE: Ten4 #12717

Nope, does not work that way.
We all have national health services here in Europe (as you are about to have in the United States) which all reimburse according to national rules and lesgislation (e.g. Health Canada has approved while the FDA in the US is still lagging). So what is OK or re-imbursable for Dutch National Health Service is not necessarily accepted in any other European country.