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Steady_T

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Re: Hoskuld post# 477440

Monday, 12/23/2024 9:08:30 AM

Monday, December 23, 2024 9:08:30 AM

Post# of 515571
I guess I'm the Grinch on this.

Acceptance is a NECESSARY step. It is not that big a deal. It mostly means that the filling contains all the required modules and they are in correct electronic format.

Acceptance is not an opinion on the contents of the submission.

I see this as the second step in a long journey. The first step gets you started. The second step gets you moving forward. 210 working days is the decision target. That works out to be an average of 465 calendar days based on the recent EMA data.

Nunc est Bibendum

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