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Re: DewDiligence post# 221024

Monday, 09/24/2018 5:02:17 PM

Monday, September 24, 2018 5:02:17 PM

Post# of 251799
From SNDX's PR:

Syndax also announced today that ECOG-ACRIN Cancer Research Group has informed the Company that enrollment in the ongoing E2112 Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer is now scheduled to close in late October. The Company will release the results of the PFS analysis following its review, and anticipates communicating this in the fourth quarter.

The trial remains ongoing, with interim overall survival (OS) analyses scheduled to occur every May and November until either the appropriate number of events are achieved or definitive interim results are obtained.

If the PFS analysis is positive (i.e. statsig based on the allocated alpha), then the trial will be unblinded immediately and SNDX will submit an NDA regardless of what the OS data to date show.

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