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misiu143

01/25/19 2:00 PM

#34168 RE: Amatuer17 #34167

Amatuer - if study for pivotal mono will start within couple of months it will have a very good chance to finish in 2019.

If they will be doing in 2 parts as they were planning.
6 weeks induction stage
24 weeks maintenance stage.

Enrollment should not be a problem with mono ..

I dont know how many mg is decided or not yet decided but he said probably in about 2 weeks or so will be PR.

He stressed few times that they have a very good talks with FDA.