There really isn't any way for this NOT to pass muster.
WISHFUL THINKING!
All the FDA has to do is say, "APPLICATION REJECTED! The technology is not accurate and the test results are unsatisfactory", once DECN finally transmits the data it is required to submit!
The claim is kinda like saying, "A COVID-19 vaccine developer is currently conducting an FDA Phase 1 Trial, so there really isn't any way it won't be approved."
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