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Re: DewDiligence post# 210475

Wednesday, 04/05/2017 6:15:13 PM

Wednesday, April 05, 2017 6:15:13 PM

Post# of 251709
AGN’s PR on phase-2 Botox depression trial:

http://finance.yahoo.com/news/allergan-reports-topline-phase-ii-203000719.html

The BOTOX 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment (LS mean) difference for 30 U was -4.2 at 3 weeks (p- value 0.005); -3.7 at week 6 (p-value 0.053) and -3.6 at week 9 (p-value 0.049). The primary end point was at week 6. The 50 U did not demonstrate superior efficacy over placebo (LS mean difference was 1.3).

Both secondary efficacy variables (CGI-S and HAMD-17) showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for 30 U, but not for 50 U.

The efficacy comparison of the combined 30U + 50U Botox arms vs the combined placebo arms was not statisg, or the PR would surely have said so. This plus the inverted dose response spell trouble for the phase-3 trials, IMO.

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