(Total Views: 239)
Posted On: 02/28/2019 8:59:04 AM
Post# of 154734
Quote:
I too will like see what is up with mono pivotal
If they will allow them to use all this new 700 mg patients for it ,
I believe they are going to, otherwise I'm not sure why cydy would enroll a lot more 700mg patients before the pivotal trial. I found it interesting, the fda didn't just switch all patients on combo and mono to 700mg. If you look at the mono trial now after that meeting, they list it randomized 350 vs 525 vs 700mg. This dose vs response rate I feel is a critical aspect the fda wants to look at, explaining the rebound issue the fda wanted them to address and also improving the responder's rate.
https://clinicaltrials.gov/ct2/show/NCT02859961
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