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Re: dmb2 post# 569136

Monday, 02/20/2023 6:21:24 AM

Monday, February 20, 2023 6:21:24 AM

Post# of 704418

flipper44, agreed that is the question but the only reasonable answer to me is that means the MAA has been submitted or is being submitted on a rolling basis.



Totally agree dmb2.
The trial was an adaptive trial, so constant consultation and follow-up with the authorities.
Advice and joint solutions have also been found. Consider, for example, change of endpoints and definition of GMB by the authorities.
Why should this not be possible in the process of commercialization and approval?
I think behind the scenes there is real cooperation with the authorities to market the product in the right way and above all effectively.

best to you.
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