,we’ve overcome some supply chain issues that have been required to(43.17)finish the potency assay for the inventory(43.21)that we’ve already built. Ahfor the commercial products. (43.25) Ah, that we’re in the process now(43.31)of validating
I don't see why we would need further testing . I presume that you believe the term " process now of validating " suggests that we are now going back through the data to see if the results correlate with outcome .
But didn't SI say that they had the data more than 6 months ago.
I would suggest the validation is more about the testing procedure and the accuracy of it. Do we need 2 tests or do we need perhaps 10. How do we take the samples from the batch . There would be many parameters that need to be set to insure consistent test accuracy . A little hint comes in the next sentence. And those three things: clinical effectiveness;(43.40), um,potency assay(43.45)and reagents to actually do the potency assay on our(43.53)existinginventoryah,we think will carry the day.
Reagents ??? Good luck
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