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Posted On: 11/01/2023 1:12:10 PM
Post# of 148863
Re: Evil Rabbit #138590
Cyrus might be the “face of completion” but we know there are multiple components involving a lot of documentation, some of it specialized, like package insert detail updates based on a comprehensive safety analysis or even the analytics related to safety across studies. Much like an orchestra, you have a conductor, but they are orchestrating the contributions from the string, brass, percussion etc sections. I see the hold lift effort as an analog to that, ergo the need for consultants who have specialized knowledge for the task or contribution effort needed. If the hold lift were announced today I would see it as a team effort even if Cyrus submitted it on the company’s behalf. My hope is that the FDA likes orchestra music enough to pull their “timbre” out and stamp APPROVED!
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