Riztheinveator , This decision , if no other decis
Post# of 148110
(Total Views: 607)
Posted On: 06/16/2021 3:50:58 PM
Re: Riztheinvestor #93862
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.
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.
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