Does anyone have any views on what is required in terms of testing requirements by adding anteobind to existing tests.
Do existing tests have to be resubmitted for FDA testing if anteobind is added as this would be a change in the test makeup ....which would mean going thru lengthy and costly FDA testing again by drug companies for tests already approved earlier.
Could anteobind and anteotech obtain a singluar approval from the FDA for application to all potential tests in the US market ... existing and future tests being developed by Drug companies.
Or is anteobind more likely to be used in new tests only simply because of the cost of potentially having to resubmit existing tests to the FDA.
Very curious on any comments as I see this as a barrier to wide spread adoption of anteobind
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