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Re: hyperopia post# 611505

Wednesday, 07/19/2023 10:38:55 AM

Wednesday, July 19, 2023 10:38:55 AM

Post# of 708782
Hyperopia is 100% right. (follow the money).

-> As for rolling review or not?
The fact the it takes aprox 60 days per modules during a rolling review, but it took ~ 25 days per modules for NWBO tells me that they are not in a rolling review. (and asm text overall).

I think that they are aiming for the 180 days (clock stop excluded) option that will be process through multiple countries once submitted. In total this option take aprox 14-16 months after CHM meeting.

For NWBO I believe it will take longer (not because management bad blah blah blah but because it is a novel drug).

MAA aproval for UK early 2025. We almost there.
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