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Posted On: 09/05/2019 8:49:08 AM
Post# of 148891
Re: Nt2innvovate #7351
Nt2- This was with longer overlap , I believe overlap at this time was 3 weeks .
For pivotal mono they planing now 4 weeks overlap .
At the time they had some patient on 700 mg with 3 weeks overlap and efficacy was about 90% , this is when FDA started to advice them to stay with 525 , so I really don’t understand why FDA is delaying all this official decision about dose ..
Starting to look little suspicious to me !!!!
For pivotal mono they planing now 4 weeks overlap .
At the time they had some patient on 700 mg with 3 weeks overlap and efficacy was about 90% , this is when FDA started to advice them to stay with 525 , so I really don’t understand why FDA is delaying all this official decision about dose ..
Starting to look little suspicious to me !!!!
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