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25/08/23
10:23
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Originally posted by Deruyter:
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“It’s quite an exceptional company with a medical advisory board of the who’s who of the cardiovascular space,” Pachacz says. He says AVR has had some exceptionally good results in an early feasibility study with plans for a pivotal study involving around 200 patients. “There’s two main competitors – Edwards Lifesciences and Medtronic,” he says.“So this company will probably get acquired at some point by one of those two companies, I would’ve thought” ——————————————— That planned pivotal study patient number of (only) 200 is new to me, much smaller than 1000+ patients I have seen mentioned elsewhere on this forum. Wonder if that would lead to an early 2025 FDA approval perhaps.
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Highly doubt it will only be 200. Like others have said, competitors with newer iterations have had to run 1,000 patient studies.