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Monday, May 04, 2020 10:13:37 AM
Berman's original estimation of sales was Sept 2020, which I think is accurate, but under the FDA guidance, if the test is determined to be a serology test, it can be manufactured and distributed immediately only subject to certain labeling restrictions. That Berman is doing the EUA suggests one of two things: either he wants the additional affirmation that comes with the EUA, or the test was not determined to be a serology test. I'd bet the test (if it was validated in S.Korea) has them flummoxed a bit - and as we all know, Berman's language did/does not make understanding what he is doing very easy! There is little doubt that if the test is validated and the EUA granted, the "large revenue stream" will take care of itself. It would be a game-changer for the "back-to-work" market for sure. And, I think that is it's value - not to mention what it could do if we in fact do see a 2nd and 3rd wave of this virus or it's mutant children.
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