PPP001* – Smokable Bio Cannabis Pharmaceutical
A prescription controlled drug for management of uncontrolled pain in cancer and AIDS patients and patients with Rare Disorders (Orphan Drug).
- Type B pre-IND meeting with FDA scheduled January 2017.
– Discussion of road map to market.
- Submitted two applications for Orphan Drug Designation.
– Protecting markets with 7-year exclusivity.
- Submitted Request for Designation to FDA to obtain binding confirmation of regulatory path and requirements.
– Nov. 8th 2016: FDA confirms Combination Product status with jurisdiction assigned to CDER, FDA.
– Maximizing exclusivity and protecting market.
- Secured supply of GMP source of medical marijuana & ability to address CMC requirements of 505(b)(2).
– A key Language for FDA and physicians.
- Phase I trial – Pharmaceutical safety study in healthy human volunteers.
– Defining the benefit to risk for human subjects.
– Conforming to a first significant issue for physicians & 505(b)(2).
- Phase II-III and Expanded Access Program – Canada-USA initiated in Q3 2017.
– Substantial evidence of effectiveness
- Based on regulatory precedents, anticipating submissions for marketing approval in Canada and USA in early 2019.