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ghmm

04/02/18 4:17 PM

#218206 RE: DewDiligence #218201

hazard ratio of 0.26 and a p-value of 0.023



Doesn't that p-value seem kinda high for such a low hazard ratio with n=98?
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iwfal

04/03/18 1:59 AM

#218220 RE: DewDiligence #218201

SLS - a lot of strange things in that PR, among them:

1) DSMB gives out results for a blinded trial, albeit single blinded, at interim despite not being stat sig overall

2) my guess is the non- picked subgroups (ie hormone treated and not TNBC) probably had an HR meaningfully above 1. If so this implies the HR seen in the subgroups is suspect.

3) The company announced complete enrollment of 300 people in Sept, but the PR was only for 275. Where did the other 25 go?

4) why does the relative risk reduction not equal 1-HR?

5) and just a reminder that this is a GALE drug and a GALE trial.