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Anshu2

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Anshu2

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Thursday, 09/14/2023 7:02:46 PM

Thursday, September 14, 2023 7:02:46 PM

Post# of 463447
Let’s ASSUME that all the information in the PR is absolutely accurate. Then what?

I’d say then it’s reasonably convincing for AA and/or even full approval — except for one addition issue: data on different dosage arms (note that the drug can only be approved for a specific dosage — so pooled analysis must not be sufficient).

In spite of all the missing information in the PR, the AD situation is certainly much better now than before.
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