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Thursday, July 30, 2020 11:04:30 AM
Looks like its pertaining right to Decn.
NO IT DOES NOT! I suggest reading the FDA Template. It is solely focused on saliva and nasal sampling. DECN's only Pre-EUA Application for a Home Kit samples blood! There has been NO DECN Pre-EUA submission for a Home Kit, based on saliva sampling. Plus, any attempt to receive an EUA, based on a blood sample, would mandate the submission of one of the new Templates, which requires substantial testing and ancilliary reporting.
FYI, there is NO CHANCE the FDA will authorize a blood sampling Home Kit by those who have no clue what they are doing! Reading the new Template, if DECN chooses to pursue an EUA for a Home Test Kit, DECN will still be screwing around with testing and reporting at this time next year! Based on validity and safety concerns, the FDA's testing criteria for a Home Test appears to be far more robust than the point-of-care tests. DECN does not have the wherewithal or resources to efficiently complete the required testing protocols.
BTW, I would love to see a copy of a DECN FDA Template for any of its blood or saliva modalities! It has the potential to be the best investor information that Berman has heretofore made public! LOL! The public will NEVER see one of DECN's FDA Templates, because it would be far too revealing!
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