What is new that's coming out today? Yeah, first of all, there have been waivers of those switching studies that have been granted by the fda. Now we're going to issue clear final guidance that those [switching studies] are not required. The uncertainty makes it difficult for drug developers, as you know, Zach, with capital markets, they want predictability. (24:15–24:20)
CLAIM
Asserts that the FDA will issue guidance stating switching studies are not required.
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