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mc73

07/13/23 2:54 AM

#163068 RE: S ceeate #163066

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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SC8

07/13/23 8:27 AM

#163075 RE: S ceeate #163066

Sorry, not gonna break it down any further. The statement only indicates when MK plans to submit protocol to FDA. The statement in no way states when a pre-sub meeting is anticipated, although I acknowledge a casual reader may have that impression that the submission and meeting are supposed to happen same week. I'm not a casual reader.