MoAA mode of action (MoA) describes a functional or anatomical change, at the cellular level, resulting from the exposure of a living organism to a substance.
If I understand the FDA's requirements, once a MoA is discovered, then clinical trials need to be re-initiated. This might be the case with Ryplazim as MoA was published during the reveiw stage of an NDA.
Does anyone understand this, and whether this is true or not? Informed comment wanted. I am looking for an objective response here. (Sky-pie go take a cold shower)
I am sticking with my view that a conditional approval is the best we will get. But in all likelyhood we will need to do an additional Ph 3.
The truth is out there somewhere.