I read the FDA guidance for validation. It's easily satisfied and with the amount of test data they've generated from testing in Korea I would not be surprised AT ALL if they notified FDA of validation next week or the following.
From a leadership point of view I think DECN just wanted to really make sure they had funding to ramp of production of genviro.
As long as their test has decent specificity/ sensitivity there wont be any regulatory barriers in their way preventing them from bringing it to market it in the USA. They'd just need to ensure quality manufacturing and an efficient distribution/marketing/sales network.
They also have to submit an EUA application within 15 days of validation. And while the EUA is temporary, it'll definitely be in effect through the summer. We're no where near as accurate number of diagnosed people and this thing is going to continue to spread.
After I reviewed the FDA guidance this whole thing just kind of clicked into place for me. No wonder the CEO said the timing/positioning was good.
From a leadership point of view I think DECN just wanted to really make sure they had funding to ramp of production of genviro.
As long as their test has decent specificity/ sensitivity there wont be any regulatory barriers in their way preventing them from bringing it to market it in the USA. They'd just need to ensure quality manufacturing and an efficient distribution/marketing/sales network.
They also have to submit an EUA application within 15 days of validation. And while the EUA is temporary, it'll definitely be in effect through the summer. We're no where near as accurate number of diagnosed people and this thing is going to continue to spread.
After I reviewed the FDA guidance this whole thing just kind of clicked into place for me. No wonder the CEO said the timing/positioning was good.
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