Active
Indication
FORMULATION
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
Transdermal Synthetic CBD
Parkinson’s Disease
Transdermal Dronabinol (THC)
Parkinson’s Disease
Potential 505(b)2 pathway
Potential 505(b)2 pathway
- Targeting an accelerated 505(b)2 registration pathway allows Sponsor to reference existing clinical safety and efficacy data – reducing risk, cost, and time to FDA approval.
- Potential to leverage pipeline for investigation into treating other serious neurological diseases.