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Post# of 428749
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HDGabor

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HDGabor

Re: Freifaller post# 304534

Monday, 10/12/2020 7:45:22 PM

Monday, October 12, 2020 7:45:22 PM

Post# of 428749
F-

The October agenda tells one thing only: no immediate* answer. (* is only used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.)

I checked the last 4(-5?) agenda and none of the contain any "restart of the clock" after the answer for the LoOI / Day 180 letter. (Meanwhile the "restart of the clock" after the answer for the LoQ / Day 120 letter is part of the agenda.)

Case A.: no answer yet
Case B: answer was submitted ... the application will be in the November agenda

Best,
G

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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