A lot of investors are forgetting that the primary end point for the FDA EFS study is only 30 days!
So we know approval is imminent, but let’s say it takes another 30 days for the green light (but could be any day now), let’s say recruitment takes 30 days, and results take 1 month after the 30 days. That’s another 4 months and just in time to be released as “Breakthrough” trial results at PCR London Valves. The biggest European structural heart conference.
That’s the company plan although it is reliant on FDA timelines. But very doable IMO.
Add onto that additional results from the Georgia patients and there is no shortage of newsflow. But the FDA news will be the biggest.
Plus, one must not forget that our results are very impressive and the Laminar flow is unique in the industry. Very good grounds to meet all required criteria for DurAVR to be granted Breakthrough Device Status. More potential news to come.
Things are certainly going to get very interesting and exciting from here.
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