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Re: S ceeate post# 163066

Thursday, 07/13/2023 2:54:50 AM

Thursday, July 13, 2023 2:54:50 AM

Post# of 197856
I have to agree with you here. They said next week they will submit the gentoxicity protocol AT a pre-sub meeting. Not sure how else to intrprete that they will be at s meeting with FDA when they submit it.

They still need to perform the scoping studies for genotoxicity as requested by FDA. I have no idea how long that could take.

"Next week we will submit the protocol to the FDA for review at a Pre-Sub meeting as they recommended."
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