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Re: boi568 post# 508123

Friday, 11/14/2025 5:39:10 PM

Friday, November 14, 2025 5:39:10 PM

Post# of 517462
As I parse the regs and the statement by the company, I get two things. First, the company can address the concerns raised by the OE and provide data to the CHMP to address those concerns. Second, the reexamination can not include information that was not presented during the first examination. That means information provided prior to the final vote is eligible for consideration and reexamination.

To me that means that Anavex has a window of opportunity between now and the December meeting to provide additional information that has not been included in the original MAA. Once that window closes in December the record is closed and the reexamination will not get any new information for it to consider.

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