I didn't think it would take until Q3 of next year to start the pivotal trial. Knowing how many participating sites to expect will be helpful. I haven't seen or heard any specifics on that, maybe somebody else has. Getting through each hospital's internal review takes time, as we saw from the EFS. Some will be quick as others drag on. There were issues with key hospital staff overturn in general post-covid that probably slowed the EFS so maybe that has been alleviated to some extent. What we don't know is whether having half of patients implanted with approved devices will speed up enrollment of the pivotal as that's not something that's been done before in a TAVR trial. Not sure how that process will work and how it will be different from typical implantation of Edwards or Medtronic devices other than paperwork.
AVR Price at posting:
$10.54 Sentiment: Hold Disclosure: Held
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