Monday, April 20, 2020 2:03:52 PM
Because they chose and finalized which design proposal to go with doesn't mean they are ready with products in hand to test and file EUA application with data. I thought it was striking that in their PR about FDA conversations they stated that the testing would be "rigorous" I believe. They then said that they were putting in orders for the materials needed to produce the test kits.
Whether or not they have all of the needed materials in question in some quantity so as to be able to construct a limited supply of test kits to perform the necessary FDA blood requested testing we do not even know.
What I'm looking for with next PR is something to the fact that materials are being provided or in hand, they have constructed a few testing kits by hand and initial results indicate the tests will indeed work.
I think that is much more realistic than "imminent approval" of a test kit they had designed on paper at the time of the Pre-EUA submission.
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