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Re: Cyosol post# 17005

Wednesday, 02/17/2021 4:57:55 PM

Wednesday, February 17, 2021 4:57:55 PM

Post# of 21544
I followed a company one time where it took years to get approval for their colorectal diagnostic test. I guess it can be a long give and take process with questions from the FDA and then months for a response. You may can sell them without but I think the 510k is what you may need for significant sales. I'm certainly no expert on devices. That was my original take but things may have changed for them since. Interesting how the new name mirrors our post merge entity. Honestly I hadn't noticed the new name until your post. I check that site regularly but had not noticed. Maybe there is indeed movement on that front.

Obviously I hope the diagnostic gains acceptance (even though its not ours) as it would certainly be confirmatory for us but to be honest, biomarkers scare me a bit because we really don't know the cause of AD.
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