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Friday, 05/05/2017 12:20:47 PM

Friday, May 05, 2017 12:20:47 PM

Post# of 17447
I am hoping that the FDA allows Aurinia to complete the expanded Phase III process so that no stones are left unturned. Again, historically, the FDA has asked companies to stop in the middle of a test and bring them the preliminary results just to shoot them out of the water and make them start over again with the same test. We don't want that to happen. My reading of the literature tells me that the Phase III test is designed to succeed. What we don't want, again, is a wary FDA that comes in and tells the company that the Phase III test isn't as far removed from the Phase II test as it should be, so protocols need to be tightened and the test needs to be repeated. Hopefully Aurinia has a team working with the FDA to make sure everyone agrees on the protocols. Once the first indication for the product is approved, its new familiarity should help additional indications be perused a little quicker.
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