MDD: So a U.S. trial is central to your clinical development program? van Kasteel: It is fair to say the FDA has tremendously raised the bar on troponin testing. Over the past few years there were not a lot of companies that were able to get FDA approval for troponin tests
this is also an interesting comment on how hard FDA approval is to get ..... Obviously due to accuracy / inconsistent test results big advantage to go with m&g to improve test results and also cost depending on what balance you need
Interesting interview re Minicare system, page-22
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