I agree that recruiting for the EFS may have started (just couldn't resist slipping in an imminent reference). The company may wait for the first implantation to issue a press release, but all indications are that the small trial will have to be run first, then be evaluated by the FDA before the large trial is designed.
It does make sense that the Georgia trial would serve as the test trial, especially because the EFS should be relatively about the same size, but the company has stated many times that the EFS will come first, then the large pivotal trial. I know of another medical device company that did a foreign trial and was able to skip the EFS but my guess is that the FDA won't allow skipping a step with a heart valve being so vital to sustaining life.
AVR Price at posting:
$24.95 Sentiment: Hold Disclosure: Held
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