Riztheinveator , This decision , if no other decision from the FDA before , put me completely in a shock..

So there is no CLINICAL BENEFIT , you met no endpoints , no p-value,
but we will approve it , and we will give you 9 years treating patients to prove to us that drug is working ..

And because about 20-30% of patients will develop brain edema and /or hemorrhage to the brain , after this monthly IV infusion ,
just do MRI soon after the treatment so we know ...

how many patients are damage more by this...?

And 9 years later we will talk about it..

Is that actual a true story in USA ..???

How very, very sad..

All imo.