long entry from $100; PT1 $125 PT2 $143
Q1 2019 - FDA meeting outcome on Sativex;
Sativex (nabiximols) is an oromucosal spray of a formulated botanical extract of cannabis
that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:1 ratio
Approved in >25 countries outside of the U.S. for the treatment of spasticity due to multiple sclerosis (MS); sold via marketing partners
• Three positive Phase 3 trials completed in Europe
U.S. development and commercialization plan
• Evaluating NDA path for MS spasticity
• Potential for multiple indications
• >10 additional placebo-controlled trials completed
• Significant U.S. life cycle management opportunities
Epidiolex
EMA decision Q1 2019
Phase 3 TSC data Q2 2019
Dravet 2 data presentation Q2 2019
Rett syndrome Phase 3 study start Q2 2019
TSC FDA sNDA submission Q4 2019
Sativex
FDA meeting outcome Q1 2019
Phase 3 MS study start 2H 2019
Cash at 30 September 2018
$354.9m
Net cash from October financing
$324.2m
Q ending 31 December 2018 operating expense guidance
$90m–$100m
Q1 2019 - FDA meeting outcome on Sativex;
Sativex (nabiximols) is an oromucosal spray of a formulated botanical extract of cannabis
that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:1 ratio
Approved in >25 countries outside of the U.S. for the treatment of spasticity due to multiple sclerosis (MS); sold via marketing partners
• Three positive Phase 3 trials completed in Europe
U.S. development and commercialization plan
• Evaluating NDA path for MS spasticity
• Potential for multiple indications
• >10 additional placebo-controlled trials completed
• Significant U.S. life cycle management opportunities
Epidiolex
EMA decision Q1 2019
Phase 3 TSC data Q2 2019
Dravet 2 data presentation Q2 2019
Rett syndrome Phase 3 study start Q2 2019
TSC FDA sNDA submission Q4 2019
Sativex
FDA meeting outcome Q1 2019
Phase 3 MS study start 2H 2019
Cash at 30 September 2018
$354.9m
Net cash from October financing
$324.2m
Q ending 31 December 2018 operating expense guidance
$90m–$100m
Comment:
Let this winner run!
Trade closed manually:
Profits taken at 150. Watch on Q4 earnings. Epidiolex