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Saturday, April 03, 2021 10:42:04 AM
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-advance-over-counter-and-other-screening-test-development
Quidel is building their production facility in Carlsbad, CA, with operation set for the second half of 2021. The attached FDA announcement has some relevant statements concerning Sorrento. "If it's a good test, we'll authorize it", and "if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests". According to the claims, COVI-STIX is more accurate than the QuickVue. Presumably Sorrento has a warehouse full of their tests and are ready to go. At this point any reasonable person has to ask if the FDA holdup is due to a problem with the test or manufacturing standards. A company explanation would be helpful but is probably not coming, either way, thanks to all the legal vultures. I would caution any attempt to gather a crowd and head to the FDA gate with torches. The test kit is such a relatively small part of Sorrento's vast pipeline, you do not want to burn any of those FDA bridges.
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