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Re: mcbio post# 209237

Thursday, 09/21/2017 5:09:50 PM

Thursday, September 21, 2017 5:09:50 PM

Post# of 257481
VSAR -82%(!)/AH on phase-3 failure in pediatric GHD:

https://finance.yahoo.com/news/versartis-announces-phase-3-velocity-203000629.html

Non-inferiority versus daily growth hormone [i.e. Genotropin] was not demonstrated in the intent to treat (ITT) population for the primary efficacy variable, height velocity (HV) at 12 months. The 12-month HV for ITT patients receiving somavaratan twice monthly was 9.44 cm, versus 10.70 cm for those receiving Genotropin daily.

Non-inferiority was defined as the lower bound of the two-sided 95% confidence interval of the difference between somavaratan and Genotropin HV greater than or equal to -2.0 cm/year. In the ITT study population the lower bound of this confidence interval was -2.3 cm/year.

Actually, a pretty close miss given the agreed-upon NI interval. Non-inferiority (according to the above definition) was met in the per-protocol population, but that's small consolation.

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