I'm always skeptical of the chance to get a Breakthrough Device/Therapy designation because I've watched other companies fail but once we show the benefit when it comes to mean pressure gradient compared with current valves in FDA approved study patients...we've got a really good chance. We've seen how slow the process is with the FDA so far and a BTD designation would definitely help to expedite proceedings.
AVR Price at posting:
$25.82 Sentiment: Buy Disclosure: Held
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