Thanks, so it appears that the FDA could approve a indication that would be around 3 times the size of children alone.
Will they ?
My limited understanding is that AA would give the FDA power to force MSB to carry out additional studies on real world evidence through a register . This would fill the requirement of additional data that AA requires. They would simply review the data periodically and adjust the lable use as appropriate.
So if the FDA goes with AA in children and adults, would AA limit "Off lable " ?
Even though MSB has yet to produce a successful P3 in adults, the data from the companional adult study could only be described as compelling.
Will they?
Compelling evidence unsuitable for full approval
The boss looks to be very supportive and is inline with the incoming administration.
AA gives more power to what appears to be a power hungry administration.
AA would be a means by which FDA could save face.
AA may limit off lable.
@reginaldp, I give that FDA job to Phaedrus, far more knowledgeable of the FDA requirements and can smell a rat miles away.
(20min delay)