2023 The Final Countdown, page-363

MARCH 21st - FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing

" If FDA determines that it is necessary to conduct the inspection at a time when the product identified in the application is being manufactured, FDA will notify the facility so that there is sufficient time for the facility to adjust its
manufacturing schedule as needed. For original NDAs, FDA’s goal is to provide this notification at
least 60 days in advance of the PAI and no later than midcycle."

So from this we could guess, the midcycle review (which had a target of April ), will occur after the inspection, which is likely around 20th May.

This would give MSB the mid cycle review phone call likely towards the end of May / start of June, and almost definatly by mid June given the PDUFA date is Aug and there needs to be a final review after the initial review and the labelling discussion.

What will the label include?

I am guessing sub 12 years old, Cat D, Minessota high risk or high MAP score.
Then in the phase 4 trial all ages, Cat D, MHR or high MAP, possibly pre - steroids

Expect a lot of off label use in this case.