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rogers711

07/16/25 7:22 PM

#189919 RE: Augster #189916

I think it requires an announcement within 4 days 
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CatfishHunter

07/16/25 7:23 PM

#189920 RE: Augster #189916

Absolutely could have been submitted earlier than the announcement date.  As you mentioned it's done through an electronic portal so pretty instantaneous to hit send and have FDA receive it.  MK could have had the PR already written and submitted PR shortly after IDE was submitted, 8am EST.  JMO.