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Re: Steady_T post# 347001

Friday, 01/28/2022 1:19:53 PM

Friday, January 28, 2022 1:19:53 PM

Post# of 461773
Yes, that is basicially what I was trying to say in my post. And, I am growing increasingly thinking along those lines. It is my thought that TGD has had this strategy to using the rolling approval all along, and with the necessary AVATAR data in hand, he is finally in the position to present the plan to the FDA. They need to see AVATAR data before they can evaluate and grant the rolling submission request, which I suspect has just occurred.

A major point that TGD will have been discussing with the FDA, IMO, is how to preseve and use the voucher; which, we seem to have concluded from the statutory language, requires the pediatric approval be first. Maybe to get into the voucher discussion, there was a peek at the EXCELLENCE data so they could show that to the FDA and line up a possible rolling submission that aims directly at the pediatric approval, not the adult approval!
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