3 Positive Phase 3 from Sativex - FDA meeting for regulatory pathway to U.S. expected in December.
Resumed @ Piper Jaffray on Nov 5th as overweight; The Street updated to sell after the drop ; Market edge on avoid.
-Epidiolex launched on November 1st in the U.S. and now available by prescription
-Sales organization actively engaging with clinicians
Epidiolex demand coming from both major centers of excellence and local epilepsy clinics
Active engagement with U.S. payors ongoing
Epidiolex now covered on growing number of formularies
U.S. supply chain distribution network operational and filling prescriptions
Commercial footprint in place in 5 major European markets in preparation for 2019 European launches
DEA rescheduled Epidiolex to Schedule V
Scheduling decision specific to FDA approved CBD
European submission under review by the with decision expected in Q1 2019
Positive results in second Dravet syndrome Phase 3 trial
Primary endpoint achieved in both Epidiolex doses (10 mg/kg/day and 20 mg/kg/day) compared to placebo
Both Epidiolex doses also demonstrated statistically significant improvements versus placebo in all key secondary endpoints
Phase 3 trial in Tuberous Sclerosis Complex fully recruited with data expected H1 2019
sNDA submission expected in H2 2019
IND submitted for pivotal Rett Syndrome study with expected start in H1 2019.
More details in the chart!