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Re: Ville post# 1922

Thursday, 11/09/2017 6:11:54 PM

Thursday, November 09, 2017 6:11:54 PM

Post# of 3283
Yes, I agree that needing 2 P3 studies to submit is one of the reasons I suspect. The #2 suspect has to do with the PK study they started earlier in the year. Suspect #2 was my #1 suspect as I discussed in post 1762. But after listening to the 3Q CC, I believe it has to do with needing 2 P3 studies in order to submit the BLA. I may be misinterpreting/reading too much into what JT said

RECOVER study is an international study that will enroll around 218 patients from Europe, the U.S. and other selected countries. This study is enrolling well and should yield results next year in time for us to file a BLA for ROLONTIS in the fourth quarter of 2018.

but to me that means they need both studies.