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skitahoe

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skitahoe

Re: None

Saturday, 07/09/2022 10:08:52 PM

Saturday, July 09, 2022 10:08:52 PM

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Any thoughts on whether the FDA will act significantly before the November 28 PDUFA date. I believe it's very possible in that the Soraya trial was one developed by IMGN in collaboration with the FDA and they've met the goals established then.

Frankly the FDA had seen these benefits proven in a subset of their earlier trial, they could have granted an approval years ago but they wanted more proof. Now they have it, why not make the decision to accept it early.

Gary
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