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HOUSE_OVERSIGHT_024906

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COWEN COLLABORATIVE INSIGHTS February 25, 2019 month and the average age of patients in the trial was 16 yrs, although 30% were 18 yrs or older. On the primary endpoint, 20 mg/kg Epidiolex produced a median reduction in monthly drop seizures of 42% compared to a reduction of 17% in patients taking placebo, p=0.0047. There was also a suggestion of a dose response in the data, with the lower 10 mg/kg/day dose of Epidiolex producing a median reduction in monthly drop seizures of 37%, p=0.0016. In both dose groups the difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period. GW disclosed that the trial's secondary endpoints, and a series of sensitivity analyses, confirmed the robustness of the results. Similar to Epidiolex's other Phase Ill studies, although patients on clobazam (51%) had some additional benefit, GW indicated that Epidiolex also showed efficacy in patients not on clobazam. Figure 125 GWPCARE3: Reduction In Drop Seizures Figure 126 GWPCARE3: Responder Analysis 50 z = Treatment Period 70 Maintenance Period A MCBD 20 mglig (n=78) sen 94 ni i ; g i t CBD 10 mpg (n=73) tpl). 005 al ‘pe0.0s 0, Ea ce 340 { PLE (n=76) a a fpe0.001 Ras e i = g zai Baseline median (@1, Q3) drop seizure frequency: ; = , 8 + CBD 20 mg/kg: 88 (38, 162) ;* 7 ry: «* 3% «CBD 10 mg/kg: 87 (41, 190) Ro a x ; Yn + Placebo: 80 (48, 148) = : E 7 # 20 = 20 € 5 . : 10 Estimated treatment differences vs placebo a 15 * " 13 Ss = CBD 20 mg/kg: -21.6 (25% Cl: -34.8, -6.7) © CBD 10 mg/kg: -19.2 (96% Cl: -31.2, -7.7) a 9 - 0 225% 250% 27% 225% 250% 275% Treatment Period (Primary) Maintenance Period @CBD 20 mg/kg (n=76) =CBD 10 mg/kg (n=73) ™@PLB (n=76) Source: GW Pharma, AAN 2017 Source: GW Pharma, AAN 2017 Additional data were presented at AAN 2017. Included in this presentation were several of the trial's secondary endpoints and a series of sensitivity analyses. All of these confirmed the robustness of the results. F

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