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Shepo69

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Shepo69

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Monday, 11/29/2021 2:36:14 PM

Monday, November 29, 2021 2:36:14 PM

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Kind of a long read, but interesting if you have not read it, and care about what is happening here. https://www.khlaw.com/sites/default/files/2021-10/Bidi_Motion_to_Stay_and_Addendum-11th_Circuit_Court_of_Appeals.pdf

Especially section IV. No Requirement For Long-Term Studies page 7 which up until Sept, the FDA said there was no need for, but then seemed to base their MDO for Kaival on this one point.

And which is seems Kaival has just answered with this new PR>
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