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Re: k9uwa post# 492101

Saturday, 06/21/2025 10:38:42 AM

Saturday, June 21, 2025 10:38:42 AM

Post# of 493513
My understanding is different than yours. While we are in the first clock stop, Anavex, not CHMP, restarts the clock by submitting its response to the questions it received. We very likely will hear about this from CHMP, not Anavex.

If CHMP is not fully satisfied with the response, it will initiate a second clock stop later with a list of (unresolved) issues.

This protocol means that the need for a second clock stop is more significant than the length of a first clock stop. (The length of the first clock stop provides a clue, however, about the degree of difficulty the list of questions posed and/or the thoroughness of the company's response.)
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