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DewDiligence

05/08/18 6:11 PM

#218925 RE: poorgradstudent #217246

RETA upsizes phase-2 PAH trial to 200 patients (from the prior range of 130-200) based on a blinded interim analysis:

https://finance.yahoo.com/news/reata-pharmaceuticals-inc-announces-first-210000898.html

The sample size range for the CATALYST trial was based upon data from the Phase 2 LARIAT trial and set at a range of 130 to 200 patients. The final sample size is determined by a prospectively-defined, pooled, and blinded sample size recalculation occurring after enrollment of at least 100 patients. The purpose of this analysis is to preserve statistical power, and it incorporates baseline characteristics and observed 6MWD variability from enrolled patients. The sample size recalculation was recently performed and indicated that a sample size of 200 patients will be sufficient to support the initial statistical assumptions and preserve statistical power of the study.

This is somewhat bearish, of course. A recent case in point: OCRX (#msg-112337117, #msg-128251911).