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SC8

07/13/23 8:42 AM

#163076 RE: mc73 #163068

You're reading it casually too. The sentence only states an intention to submit protocol this week. It doesn't say when the meeting is scheduled or anticipated. Moreover, we've been through this 4X before with RDGL. Meetings follow submissions by several weeks becuase FDA reviewers need time to review the submission beforehand.

This is how a technical writer/reader reads the sentence:

"Next week we will submit the protocol to FDA" OK, writer states an intention or forecast to submit the protocol next week (now this week).

"for review at a Pre-Sub meeting as they recommended." OK, writer states the purpose of the planned submission and that the planned submission is in compliance with an FDA recommendation. Writer is in no way is stating that this meeting has been already scheduled or when it is anticipated.
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splintered sunlight

07/13/23 9:24 AM

#163081 RE: mc73 #163068

Re-read

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

They are going to submit the protocol and then that protocol will be reviewed at a Pre-sub meeting as they recommiended, meaning at a later date IMHO.