GREY:ATBPF - Post by User
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Pragmatiston Jul 16, 2021 2:48am
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Post# 33557808
RE:RE:RE:RE:Lull before Pop?
RE:RE:RE:RE:Lull before Pop?MrMugsy wrote: Ya - I once asked Dan about fast-tracking OTENA (around August of last year).
I think his answer was ... there's no point now.
I didn't challenge further as I moved on to another question.
Which begs the question now ... when is the right time to fast-track 352?
As I understand it ... you can complete the paperwork at any point in the development cycle.
Thoughts ?
mstrmnd wrote: tuah nod
A question that I have been pondering is how much effort do you spend progressing 352 when you have a more promising new candidate close on its heels? I believe Dan stated during Radius (Apr 21) that he would work the two in parallel and hand off at the right time. And that it would be 12-15 mths before it is tested in humans. So when is the right time?
Fast track can be requested as early as IND. I suspect that the timeline will be dependent on Delriada's lab results. Clearly it would be in ATE's interests to down tools on the old molecule and focus on the new molecule at the earliest opportunity. Which would drive the schedule. And which would avoid rework.