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Summer2762

05/10/12 11:15 AM

#141721 RE: iwfal #141653

I wouldn't describe setting the endpoint of the ph iii portion



I dont think "Progression-free survival in two co-primary populations" is for P3. On page 33 of the presentation you referenced (thanks for that info as I missed that. Here is a link for others http://www.syntapharma.com/Documents/Synta_Corporate_presentation.pdf ) the co states that the primary endpoint of the P3 portion is not yet set (PFS or OS).

In that (page 33), the co states (for the P2 portion of the Galaxy trial)

Co-primary endpoint, PFS: ITT, KRAS populations
~90% power ITT: 3mo -> 5mo,
KRAS: 5wk -> 10wk

So it seems like they consider ITT as the other subpopulation.