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  4. Decision Diagnostics Corp (DECN) Message Board

Message board posters yet again know how to run th

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Post# of 11803
(Total Views: 630)
Posted On: 07/30/2020 10:23:59 AM
Posted By: plutonium
Message board posters yet again know how to run the company almost as well as they run their mouths. It is just all so easy. The FDA did nobody any favors with this guidance. They kicked the can down the road 120 days. If you believe there are companies that can get this done in 120 days, including a 100 patient (minimum) clinical and that ridiculous Flex Analysis where companies have to report about of all the things that can go wrong, and test for them so the FDA can come back and tell you you're wrong, and quote 10 points of the law. This is not easy. The only companies that I think can get through this maze of snakes are companies in the virus testing business that recently (2018 to 2020) had to endure this nonsense for their blood glucose products. DECN can get through this but it won't be in 90 days (because blood glucose reviews take 6 months minimum) and it will be expensive. And then that begs the question of who reviews the at-home EUA application? Certainly the staff FDA currently has is not equipped to do this.


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