Sunday, October 04, 2015 3:38:32 PM
R-IT population was always TG 150-500. (Acc. to Inv. Pres. the potential market is 34M with 150-199 and 36M with 200-499, app 49/51%.). The final mix will be:
- app. 3,000 with TG 150-200
- app 5,000 with TG 200-500 (ANCHOR population)
(app 38/62%) and it is the mix as the study was designed.
They enrolled the lower risk patients (3,000 w TG 150-200) during November 2011 and May 2013, together with 2,000 who had TG 200-500. We could not say that the change was made to "back into", since we do not know how the study was designed exactly. (I mean, we do not know how they planned (when) to enroll TG 150-200 patients.).
It isn't a question, that the overall risk is higher after May 2013, but it does not mean necessarily that it was not in line with the design. The change means one thing only: they had enough patients w TG 150-200.
- the design could contain this effect
- the original expected placebo rate was 5.9%, the 5.2% is the minimum only (and both are average during the median 4.year follow-up)
Best,
G
#STRONGERTOGETHER
Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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