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flipper44

02/25/24 7:47 AM

#674514 RE: exwannabe #674496

“Cemented” within about 80 days and/or March CHM meeting, imo, dependent on when validation was confirmed. It appears it was confirmed on or before January 4, 2024.

Since cement did not mean validation, imo, it must mean a (hoped for) manageable phase I directive, otherwise she would have said upon approval.

Cement, in this context, typically means to make stronger. Stronger would be at some interim stage. Stronger would mean whatever they ask for at 80/CHM is doable within the 150 day (+ 60 day clock off if necessary), imo. Approval does not make an MAA “stronger,” it instead completes its function.

brooktrail1933

02/25/24 1:44 PM

#674570 RE: exwannabe #674496

I'm saving your post, and I've saved others you've made claiming no approval in 2024. Can't wait to re-post them after you've been proven wrong (again).

FeMike

02/25/24 2:07 PM

#674576 RE: exwannabe #674496

Cmon Ex.

If it’s approved, it’ll be in 2024.

The review is not going to take 365 days.

Even you have to admit that.

It’s not going to be in the asinine March/April timeframes people are putting out there, but a decision will happen in 2024.