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Re: dennisdave post# 798773

Thursday, 11/20/2025 1:22:32 PM

Thursday, November 20, 2025 1:22:32 PM

Post# of 820735

What people here keep missing is that if an ATMP review expands its CMC package (in this case Flaskworks/Eden) during an ongoing MAA review, then the standard 210-day review timelines no longer applies is out of the window.


OK.

So when we hear in 6 weeks that NWBO has not yet started the testing on Eden needed to be submitted for the MAA change, how does that play out in the timeline to approval?

And why did NWBO slow play this?
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